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

NCT ID: NCT01695044

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-02-28

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PSMA ADC

Intervention Type: DRUG

PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.

Interventions

PSMA ADC

PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivien Wong, PhD

Role: STUDY_DIRECTOR

Progenics Pharmaceuticals, Inc.

Locations

Birmingham, Alabama, United States

Tucson, Arizona, United States

Burbank, California, United States

Encinitas, California, United States

Los Angeles, California, United States

San Diego, California, United States

Denver, Colorado, United States

New Haven, Connecticut, United States

Norwalk, Connecticut, United States

Port Saint Lucie, Florida, United States

Honolulu, Hawaii, United States

Fairway, Kansas, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Rockville, Maryland, United States

Boston, Massachusetts, United States

Ann Arbor, Michigan, United States

Rochester, Minnesota, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Lake Success, New York, United States

New York, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Huntersville, North Carolina, United States

Raleigh, North Carolina, United States

Cleveland, Ohio, United States

Pittsburgh, Pennsylvania, United States

Providence, Rhode Island, United States

Greenville, South Carolina, United States

Myrtle Beach, South Carolina, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Norfolk, Virginia, United States

Seattle, Washington, United States

Countries

United States

Other Identifiers

PSMA ADC 2301

Identifier Type: -

Identifier Source: org_study_id