A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01695044
First received: September 25, 2012
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of 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). If a subject has received more than two cytotoxic chemotherapy regimens, Sponsor approval is required for study participation. 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 Intervention Phase
Prostate Cancer
Drug: PSMA ADC
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Progenics Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Anti-tumor response [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    Changes in tumor assessments (RECIST 1.1 criteria), changes in serum PSA and circulating tumor cells


Estimated Enrollment: 110
Study Start Date: September 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: PSMA ADC Drug: PSMA ADC
PSMA ADC administered IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695044

  Show 36 Study Locations
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
Study Director: Hagop Youssoufian, MD Progenics Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01695044     History of Changes
Other Study ID Numbers: PSMA ADC 2301
Study First Received: September 25, 2012
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014