- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02020135
An Open-label Extension Study of PSMA ADC 2301 in mCRPC
February 21, 2017 updated by: Progenics Pharmaceuticals, Inc.
An Open-label Treatment Extension of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
PSMA ADC 2301EXT is an open-label study to further assess the anti-tumor activity as measured by radiographic imaging and biomarkers, safety and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in subjects with mCRPC.
Subjects who have participated in the PSMA ADC 2301 study and who, in the opinion of the Principal Investigator are likely to benefit from continued treatment with PSMA ADC are eligible for the PSMA ADC 2301 extension study.
Subjects who are benefiting from treatment may be able to receive up to an additional eight to sixteen doses (every 3 weeks) of PSMA ADC.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States
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Louisiana
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New Orleans, Louisiana, United States, 70112
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Maryland
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Baltimore, Maryland, United States, 21201
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Nevada
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Las Vegas, Nevada, United States, 89169
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New York
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Stony Brook, New York, United States, 11794
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Subjects who have completed the PSMA ADC 2301 study and who, in the opinion of the investigator, are likely to benefit from continued treatment with PSMA ADC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- If chemically castrated, subjects must agree to stay on androgen-deprivation therapy for the duration of the study
- If applicable, men must agree to commit to the use of a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug
Exclusion Criteria:
- An acute infection requiring ongoing antibiotic therapy (e.g., UTI, indwelling catheter or other potential site(s) of infection)
- History of significant hypersensitivity reactions to PSMA ADC or any of its components, or to any prior investigational or approved monoclonal antibodies (mAbs), immunoglobulin (Ig) fusion proteins (e.g., circulating neutralizing antibodies), or ADC
- Clinically significant cardiac disease or severe debilitating pulmonary disease
- Any recent or ongoing medical condition that may interfere with a subject's participation or compliance with the study or evaluation of PSMA ADC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Total Serum PSA Response
Time Frame: 25 Weeks
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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%.
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25 Weeks
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CTC Response
Time Frame: 25 weeks
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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%.
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25 weeks
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Overall Radiologic Response
Time Frame: 25 weeks
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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.
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25 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
December 18, 2013
First Submitted That Met QC Criteria
December 18, 2013
First Posted (Estimate)
December 24, 2013
Study Record Updates
Last Update Posted (Actual)
March 24, 2017
Last Update Submitted That Met QC Criteria
February 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSMA ADC 2301EXT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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