Clinical Trial: PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: An Open Label Phase 2 Study to Evaluate PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma
Brief Summary: The primary objective of this study is to assess the overall response rate (ORR) of von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC) tumors in VHL patients treated with PT2385.
Detailed Summary: This open-label Phase 2 study will evaluate the efficacy, safety, PK, and PD of PT2385 in patients with VHL disease who have at least 1 measurable VHL disease-associated ccRCC tumor (as defined by RECIST 1.1). PT2385 will be administered orally and treatment will be continuous. Changes in VHL disease-associated non-ccRCC tumors will also be evaluated.
Sponsor: Peloton Therapeutics, Inc.
Current Primary Outcome: Overall Response Rate (ORR) [ Time Frame: 4-5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression Free Survival (PFS) [ Time Frame: 4-5 years ]Progression free survival (PFS) in VHL disease-associated ccRCC tumors
- Duration of Response (DOR) [ Time Frame: 4-5 years ]Duration of response (DOR) in VHL disease-associated ccRCC tumors
- Time to Response (TTR) [ Time Frame: 4-5 years ]Time to response (TTR) in VHL disease-associated ccRCC tumors
Original Secondary Outcome: Same as current
Information By: Peloton Therapeutics, Inc.
Dates:
Date Received: March 28, 2017
Date Started: April 2017
Date Completion: September 2022
Last Updated: April 25, 2017
Last Verified: April 2017