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a577e819-c928-4217-8743-f4809e852919
No uncontrolled intercurrent illness Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
No active infection requiring systemic therapy Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
Able to swallow oral medications and with no medical problems or prior surgeries that may interfere with the absorption of oral medications including the following: Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
Uncontrolled nausea, vomiting, or diarrhea Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
Lack of the physical integrity of the upper gastrointestinal tract Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
Malabsorption syndrome Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
No known hypersensitivity to bendamustine hydrochloride, mannitol, or erlotinib hydrochloride Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
No prior malignancy in the past 5 years except for adequately treated basal cell or squamous cell skin carcinoma, or adequately treated stage I-II cancer for which the patient is in complete remission Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
PRIOR CONCURRENT THERAPY: Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
See Disease Characteristics Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
Prior adjuvant or neoadjuvant chemotherapy and 1 prior chemotherapy regimen in the metastatic setting allowed provided recovered from all acute toxicities Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
No prior bendamustine hydrochloride or EGFR-directed therapy Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
No other concurrent antineoplastic treatments, including radiotherapy, chemotherapy, biological therapy, hormonal therapy, immunotherapy, gene therapy, and surgery Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
Intravenous bisphosphonates allowed Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
No concurrent antiretroviral therapy for HIV-positive patients Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
a577e819-c928-4217-8743-f4809e852919
No other concurrent investigational agents Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.
1
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Objective Response Rate (ORR) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Time frame: Up to 2 years. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Arm/Group Title: NKTR-102 14 Day the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Arm/Group Title: NKTR-102 21 Days the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Central Nervous System (CNS) Objective Response Rate secondary trial: Unit of Measure: percentage of subjects 35 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Objective Response Rate (ORR) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Time frame: Up to 2 years. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Arm/Group Title: NKTR-102 14 Day the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Arm/Group Title: NKTR-102 21 Days the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: secondary trial: Unit of Measure: percentage of subjects 35 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Objective Response Rate (ORR) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Time frame: Up to 2 years. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Arm/Group Title: NKTR-102 14 Day the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Arm/Group Title: NKTR-102 21 Days the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: CNS complete response (CR) is achieved if all of the following are satisfied: secondary trial: Unit of Measure: percentage of subjects 35 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Objective Response Rate (ORR) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Time frame: Up to 2 years. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Arm/Group Title: NKTR-102 14 Day the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Arm/Group Title: NKTR-102 21 Days the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases secondary trial: Unit of Measure: percentage of subjects 35 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Objective Response Rate (ORR) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Time frame: Up to 2 years. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Arm/Group Title: NKTR-102 14 Day the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Arm/Group Title: NKTR-102 21 Days the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new CNS lesions (defined as any new lesion >= 6 mm in LD) secondary trial: Unit of Measure: percentage of subjects 35 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Objective Response Rate (ORR) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Time frame: Up to 2 years. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Arm/Group Title: NKTR-102 14 Day the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Arm/Group Title: NKTR-102 21 Days the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Measure Type: Number the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: Stable or decreasing steroid dose secondary trial: Unit of Measure: percentage of subjects 35 (14.6 to 46.3) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new/progressive tumor-related neurologic signs or symptoms secondary trial: Objective Response Rate (ORR) the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new/progressive tumor-related neurologic signs or symptoms secondary trial: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new/progressive tumor-related neurologic signs or symptoms secondary trial: Time frame: Up to 2 years. the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new/progressive tumor-related neurologic signs or symptoms secondary trial: Arm/Group Title: NKTR-102 14 Day the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new/progressive tumor-related neurologic signs or symptoms secondary trial: Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0
bd073d05-3ba2-4898-9d86-a51951a7ad1f
primary trial: No new/progressive tumor-related neurologic signs or symptoms secondary trial: Overall Number of Participants Analyzed: 35 the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.
0