Spots Global Cancer Trial Database for PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma

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Trial Identification

Brief Title: PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma

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

Study ID: NCT03108066

Conditions

VHL Gene Mutation

VHL

VHL Syndrome

VHL Gene Inactivation

Von Hippel

Von Hippel-Lindau Disease

Von Hippel's Disease

Von Hippel-Lindau Syndrome, Modifiers of

Clear Cell Renal Cell Carcinoma

Clear Cell RCC

ccRCC

Interventions

PT2385 Tablets

Study Description

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 Description: 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.