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

Prostate Cancer Clinical Trial

Official title:

A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695044
• Other study ID #: PSMA ADC 2301
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2012
• Last updated: March 10, 2015
• Start date: September 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Progenics Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• PSMA ADC
PSMA ADC administered IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-tumor response	Changes in tumor assessments (RECIST 1.1 criteria), changes in serum PSA and circulating tumor cells	25 weeks	No