Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-label Extension Study of PSMA ADC 2301 in mCRPC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020135
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : February 23, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: PSMA ADC Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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%.

  2. 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%.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  3. If chemically castrated, subjects must agree to stay on androgen-deprivation therapy for the duration of the study
  4. 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:

  1. An acute infection requiring ongoing antibiotic therapy (e.g., UTI, indwelling catheter or other potential site(s) of infection)
  2. 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
  3. Clinically significant cardiac disease or severe debilitating pulmonary disease
  4. Any recent or ongoing medical condition that may interfere with a subject's participation or compliance with the study or evaluation of PSMA ADC

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Vivien Wong, PhD Progenics Pharmaceuticals, Inc.
Layout table for additonal information
Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02020135    
Other Study ID Numbers: PSMA ADC 2301EXT
First Posted: December 24, 2013    Key Record Dates
Results First Posted: February 23, 2017
Last Update Posted: March 24, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases