An Open-label Extension Study of PSMA ADC 2301 in mCRPC
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|ClinicalTrials.gov Identifier: NCT02020135|
Recruitment Status : Completed
First Posted : December 24, 2013
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 :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Treatment Extension of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||March 2015|
Experimental: Arm 1: PSMA ADC
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
Drug: PSMA ADC
Upon recommendation from the PI and after Sponsor approval, a subject benefiting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.
- Percentage of Participants With Total Serum PSA Response [ Time Frame: 25 Weeks ]Total serum PSA (prostate-specific antigen) was measured at baseline and had at least one post-baseline assessment. PSA response was examined at two levels: at least 30% decrease or at least 50% decrease in serum PSA. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 30% or 50%.
- CTC Response [ Time Frame: 25 weeks ]Circulating tumor cells (CTC) response was measured at baseline and had at least one post-baseline assessment. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 50%.
- Overall Radiologic Response [ Time Frame: 25 weeks ]Overall radiologic response was measured at baseline and post-baseline. 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020135
|United States, Arizona|
|Tucson, Arizona, United States|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70112|
|United States, Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89169|
|United States, New York|
|Stony Brook, New York, United States, 11794|
|United States, South Carolina|
|Myrtle Beach, South Carolina, United States, 29572|
|Study Director:||Vivien Wong, PhD||Progenics Pharmaceuticals, Inc.|