Trials / Withdrawn
WithdrawnNCT03110588
Phase I Trial of PACE for Metastatic Prostate Cancer
Phase I Trial of Prednisone, Abiraterone, Cabazitaxel and Enzalutamide (PACE) for Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is being conducted to determine the feasibility and recommended dose of the combination of four drugs (prednisone, abiraterone, cabazitaxel and enzalutamide (PACE) as first-line therapy for metastatic castration-resistant prostate cancer (mCRPC).
Detailed description
Multiple agents have been shown to improve survival in patients with mCRPC by up to five months. The combination of prednisone, abiraterone, cabazitaxel and enzalutamide may be anticipated to be feasible therapy with minimal or no adverse drug interactions. This is a phase I trial to study the feasibility of the proposed therapy. Patients will undergo a combination of oral daily drug intake at varying doses over a period of three weeks. Monitoring including blood collection for laboratory testing will be done on Day 1 of each three-week cycle with additional monitoring during the first cycle. Imaging and correlative studies will be done every 12 weeks. Therapy will continue until disease progression or severe toxicities.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PACE with Cabazitaxel (15 mg/m2) | Prednisone, Abiraterone, and Enzalutamide are administered orally; Cabazitaxel is be administered intravenously @ 15 mg/m2. |
| DRUG | PACE with Cabazitaxel (20 mg/m2) | Prednisone, Abiraterone, and Enzalutamide are administered orally; Cabazitaxel is be administered intravenously @ 20 mg/m2. |
Timeline
- Start date
- 2018-05-09
- Primary completion
- 2019-12-18
- Completion
- 2019-12-18
- First posted
- 2017-04-12
- Last updated
- 2020-10-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03110588. Inclusion in this directory is not an endorsement.