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

This study is currently recruiting participants.
Verified February 2014 by Progenics Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01695044
First received: September 25, 2012
Last updated: February 10, 2014
Last verified: February 2014

September 25, 2012
February 10, 2014
September 2012
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01695044 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: PSMA ADC
PSMA ADC administered IV
Experimental: Arm 1: PSMA ADC
Intervention: Drug: PSMA ADC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
July 2015
March 2015   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Kathleen Huang 914-789-2855 khuang@progenics.com
Contact: Sandra Narain 914-784-1887 snarain@progenics.com
United States
 
NCT01695044
PSMA ADC 2301
No
Progenics Pharmaceuticals, Inc.
Progenics Pharmaceuticals, Inc.
Not Provided
Study Director: Hagop Youssoufian, MD Progenics Pharmaceuticals, Inc.
Progenics Pharmaceuticals, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP