Von Hippel-Lindau Disease Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has at least 1 measurable ccRCC tumor and no solid ccRCC tumor greater than 3.0 cm, based on radiologic diagnosis (histologic diagnosis not required); may have VHL disease-associated lesions in other organ systems
Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration

Exclusion Criteria:

Has had prior radiotherapy or systemic anti cancer therapy for ccRCC (includes anti-VEGF therapy or any systemic investigational anti cancer agent)
Has a prior or concomitant non-VHL disease-associated invasive malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the patient has remained disease free for more than 2 years
Has any history of metastatic disease
Has had radiotherapy to any non-ccRCC site within 4 weeks prior to entering the study or has not recovered from adverse events (AE)
Has had any surgical procedure for VHL disease or any major surgical procedure completed within 4 weeks prior to entering the study or has any surgical lesions from recent major surgical procedures that are not well healed

Study is for people with:

Von Hippel-Lindau Disease

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT03108066

Recruitment Status:

Completed

Sponsor:

Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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There is 1 Location for this study

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National Institutes of Health Clinical Center
Bethesda Maryland, 20892, United States

How clear is this clinincal trial information?

Study is for people with:

Von Hippel-Lindau Disease

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT03108066

Recruitment Status:

Completed

Sponsor:


Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

How clear is this clinincal trial information?

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