NCT03418324

Study of TRC105 With Abiraterone and With Enzalutamide in Prostate Cancer Patients Progressing on Therapy

A Phase 2 Study of TRC105 (Anti-endoglin Antibody) With Abiraterone and With Enzalutamide in Metastatic, Castration Resistant Prostate Cancer Patients Progressing on Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being done to measure the clinical benefit of TRC105 in combination with abiraterone or enzalutamide in metastatic, castration-resistant prostate cancer patients who are taking either abiraterone or enzalutamide and showing signs of biochemical progression without radiographic progression. A patient who is progressing on AR-therapy will continue the same AR-therapy on study with the addition of TRC105. The two arms will accrue in parallel and independently.

Detailed description

This is a Phase II, open-label study of TRC105 (anti-endoglin antibody) in combination with abiraterone or enzalutamide in metastatic, castration-resistant prostate cancer patients who are taking either abiraterone or enzalutamide and showing signs of biochemical progression without radiographic progression. A patient who is progressing on AR-therapy will continue the same AR-therapy on study with the addition of TRC105. The two arms will accrue in parallel and independently. There will be a 2-week washout of the active AR-targeted therapy prior to initiation of combination therapy. Tumor response should be assessed at a frequency of 8 weeks by CT/MRI chest, abdomen and pelvis as well as bone scan. Patients may continue on therapy until radiographic progression by RECIST 1.1 or PCWG3 criteria.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	TRC105	Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks
DRUG	Abiraterone	Patients who are progressing on Abiraterone will undergo a washout period and then continue treatment with standard dosing of Abiraterone plus TRC105.
DRUG	Enzalutamide	Patients who are progressing on Enzalutamide will undergo a washout period and then continue standard treatment with Enzalutamide plus TRC105.

Timeline

• Start date: 2018-03-05
• Primary completion: 2019-11-06
• Completion: 2019-11-06
• First posted: 2018-02-01
• Last updated: 2020-12-30
• Results posted: 2020-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study