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 ]

Overall response rate (ORR) in VHL disease-associated ccRCC tumors


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