Clinical trial NCT01695044: A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official title: A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Progenics Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 119
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Total Serum PSA Response
timeFrame: 24 Weeks
measure: CTC Response
timeFrame: 24 Weeks
measure: Overall Radiologic Response
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Burbank
country: United States
state: California
city: Encinitas
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Norwalk
country: United States
state: Connecticut
city: Port St. Lucie
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Fairway
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Lake Success
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Huntersville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Greenville
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Vivien Wong, PhD
role: STUDY_DIRECTOR
References: