Trials / Terminated
TerminatedNCT03999515
Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer
Erdafitinib Plus Abiraterone Acetate or Enzalutamide in Double Negative Prostate Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well erdafitinib in combination with abiraterone acetate or enzalutamide works in treating patients with double negative prostate cancer. Erdafitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Testosterone can cause the growth of prostate cancer cells. Abiraterone acetate lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Enzalutamide blocks the use of testosterone by the tumor cells. Giving erdafitinib with abiraterone acetate or enzalutamide may work better in treating patients with prostate cancer compared to abiraterone acetate or enzalutamide alone.
Detailed description
OUTLINE: Patients receive abiraterone acetate orally (PO) once daily (QD) or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Conditions
- Castration-Resistant Prostate Carcinoma
- Double-Negative Prostate Carcinoma
- Metastatic Prostate Carcinoma
- Prostate Adenocarcinoma
- Stage IV Prostate Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
- Stage IVB Prostate Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abiraterone Acetate | Given PO |
| DRUG | Enzalutamide | Given PO |
| DRUG | Erdafitinib | Given PO |
Timeline
- Start date
- 2020-04-27
- Primary completion
- 2021-06-06
- Completion
- 2021-06-06
- First posted
- 2019-06-26
- Last updated
- 2023-09-28
- Results posted
- 2023-09-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03999515. Inclusion in this directory is not an endorsement.