A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
|ClinicalTrials.gov Identifier: NCT01695044|
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : February 23, 2017
Last Update Posted : March 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: PSMA ADC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||February 2015|
Experimental: Arm 1: PSMA ADC
Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
Drug: PSMA ADC
PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
- Percentage of Participants With Total Serum PSA Response [ Time Frame: 24 Weeks ]Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.
- CTC Response [ Time Frame: 24 Weeks ]Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%.
- Overall Radiologic Response [ Time Frame: 24 weeks ]Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695044
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|Study Director:||Vivien Wong, PhD||Progenics Pharmaceuticals, Inc.|