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A Phase 2 Study of PT2977 for the Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03401788
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Peloton Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE January 17, 2018
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE March 20, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
Overall response rate (ORR) [ Time Frame: 4-5 Years ]
ORR per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03401788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
  • Duration of response (DOR) [ Time Frame: 4-5 Years ]
  • Time to response (TTR) [ Time Frame: 4-5 Years ]
  • Progression-free survival (PFS) [ Time Frame: 4-5 Years ]
  • Time to Surgery (TTS) [ Time Frame: 4-5 Years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of PT2977 for the Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma
Official Title  ICMJE An Open-Label Phase 2 Study to Evaluate PT2977 for the Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma
Brief Summary This study is designed to investigate PT2977 as a treatment for VHL disease associated RCC.
Detailed Description This open-label Phase 2 study will evaluate the efficacy and safety of PT2977 in patients with VHL disease who have at least 1 measurable RCC tumor. PT2977 will be administered orally and treatment will be continuous. Patients will be evaluated radiologically approximately 12 weeks after initiation of treatment and every 12 weeks thereafter while continuing in the study. Changes in VHL disease-associated non-RCC tumors will also be evaluated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Phase 2 Open Label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • VHL - Von Hippel-Lindau Syndrome
  • VHL
  • VHL Gene Mutation
  • VHL Syndrome
  • VHL Gene Inactivation
  • VHL-Associated Renal Cell Carcinoma
  • VHL-Associated Clear Cell Renal Cell Carcinoma
Intervention  ICMJE Drug: PT2977
HIF-2α Inhibitor
Study Arms  ICMJE Experimental: Open Label PT2977
PT2977 is a small molecule inhibitor of HIF-2α, which impairs hypoxic and pseudo-hypoxia signaling in cancer cells.
Intervention: Drug: PT2977
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 9, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2023
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration
  • Has at least 1 measurable solid RCC tumor and no RCC tumor that requires immediate surgical intervention. The diagnosis of RCC can be radiologic (histologic diagnosis not required). Patients may have VHL disease-associated tumors in other organ systems

Exclusion Criteria:

  • Has received prior treatment with PT2977 or another HIF-2α inhibitor
  • Has had any systemic anti-cancer therapy (includes anti-VEGF therapy or any systemic investigational anti-cancer agent)
  • Has an immediate need for surgical intervention for tumor treatment
  • Has evidence of metastatic disease on screening imaging
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   France,   United Kingdom,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03401788
Other Study ID Numbers  ICMJE PT2977-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peloton Therapeutics, Inc.
Study Sponsor  ICMJE Peloton Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peloton Therapeutics, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP