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A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (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: NCT01695044
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : February 23, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Primary Completion Date : October 2014
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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%.

  2. 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%.

  3. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of metastatic castration-resistant prostate cancer.
  2. a) Prior history of treatment with at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). If a subject has received more than two cytotoxic chemotherapy regimens, Sponsor approval is required for study participation.

    OR

    b) No prior history of treatment with a cytotoxic chemotherapy regimen.

  3. Must have received and progressed on abiraterone acetate and/or enzalutamide. If subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  5. Life expectancy ≥ six months.
  6. Cytotoxic chemotherapy-naïve subjects ONLY must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223.

Exclusion Criteria:

  1. Treatment within 30 days prior to first dose of study drug of the following:

    • External Radiation therapy
    • Radiopharmaceuticals
    • Cytotoxic chemotherapy
    • Treatment with an investigational agent
  2. Clinically significant cardiac disease or severe debilitating pulmonary disease
  3. An acute infection requiring ongoing antibiotic therapy
  4. Any prior treatment with PSMA ADC or other therapies targeting PSMA, or other antibody drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE) (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME, RG7450) unless approved by Sponsor.
  5. History of drug and/or alcohol abuse
  6. History of pancreatitis
Contacts and Locations

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): NCT01695044


  Show 36 Study Locations
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
Study Director: Vivien Wong, PhD Progenics Pharmaceuticals, Inc.
More Information

Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01695044     History of Changes
Other Study ID Numbers: PSMA ADC 2301
First Posted: September 27, 2012    Key Record Dates
Results First Posted: February 23, 2017
Last Update Posted: March 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs