Search Cancer Clinical Trials
Recruiting
Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).
- Prostate Cancer Metastatic
- ARV-110
Phase 1/Phase 2
Interventional
Primary Outcome:
- Part A: Incidence of Dose Limiting Toxicities of ARV-110
- Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110
- Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110
- Part B: Measurement of PSA response rate per PCWG3 accessing anti-tumor activity of ARV-110
- Part B: Measurement of overall RECIST response rate accessing the anti-tumor activity of ARV-110
- Part B: To evaluate the clinical anti-tumor activity of ARV-110 in patients with mCRPC
Secondary Outcome:
- Part A: Anti-tumor activity based on the overall PSA response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
- Part A: Anti-tumor activity based on the overall RECIST response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
- Part A: Anti-tumor activity based on the progression free survival in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
- Part A: Anti-tumor activity based on the duration of response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
- Part A: Anti-tumor activity based on the time to progression in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
- Part A: Anti-tumor activity based on the overall survival in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
- Part A: Concentration-time curve (AUC) for single and multiple dose of ARV-110
- Part A: Maximum concentration (Cmax) for single and multiple dose of ARV-110
- Part A: Minimum concentration (Cmin) for single and multiple dose of ARV-110
- Part A: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110
- Part B: Concentration-time curve (AUC) for single and multiple dose of ARV-110
- Part B: Maximum concentration (Cmax) for single and multiple dose of ARV-110
- Part B: Minimum concentration (Cmin) for single and multiple dose of ARV-110
- Part B: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110
- Part B: Duration of response
- Part B: Overall survival
250
March 1, 2019
- Gender: Male
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Arvinas Androgen Receptor, Inc.
Arvinas Inc.
A Phase 1/2, Open-label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer
NCT03888612
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.