A Phase 1, Multiple-Dose, Dose-Escalation and Expansion Trial of PT2977, a HIF-2α Inhibitor, in Patients With Advanced Solid Tumors

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A Phase 1, Multiple-Dose, Dose-Escalation and Expansion Trial of PT2977, a HIF-2α Inhibitor, in Patients With Advanced Solid Tumors

Condition: Advanced Solid Tumors, Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, ccRCC, RCC, Clear Cell Adenocarcinoma, RCC, Kidney Cancer, Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma, Metastatic, Renal Cell Carcinoma Recurrent, Renal Cell Carcinoma, Clear Cell Adenocarcinoma, Glioblastoma, Glioblastoma, Adult, GBM, Glioblastoma Multiforme

Intervention:

  • Drug: PT2977

Purpose: The primary objective of this study is to identify the maximum tolerated dose (MTD) of PT2977 Tablets and/or the recommended Phase 2 dose (RP2D) of PT2977 Tablets in patients with advanced solid tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02974738

Sponsor: Peloton Therapeutics, Inc.

Primary Outcome Measures:

  • Measure: maximum tolerated dose (MTD)
  • Time Frame: 3 Weeks
  • Safety Issue:

Estimated Enrollment: 125

Study Start Date: December 2016

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Has a diagnosis of locally advanced or metastatic solid tumor
  • Is of age ≥ 18 years
  • Has a life expectancy of ≥ 6 months
  • Has adequate organ function
  • If a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
  • Able to swallow oral medications Additional Inclusion Criteria for GBM cohort
  • Must have histologically confirmed glioblastoma, IDH-wild type that is first recurrent following radiation therapy and temozolomide according to the Response Assessment in Neuro-Oncology (RANO) criteria
  • Must have archival tumor tissue available from a previous surgery for glioblastoma
  • Must have measurable (defined as at least 1 cm x 1 cm) contrast-enhancing lesion by MRI imaging within 21 days of starting treatment
  • Must be able to undergo MRI of the brain with gadolinium. Patients must be maintained on a stable or decreasing dose of corticosteroid regimen (no increase for 5 days) prior to this baseline MRI

Exclusion Criteria:

  • Has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression
  • Has failed to recover from the reversible effects of prior anticancer therapy
  • Has uncontrolled or poorly controlled hypertension
  • Has malabsorption due to prior gastrointestinal (GI) surgery or GI disease
  • Has had any major cardiovascular event within 6 months prior to study drug administration
  • Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
  • Has had major surgery within 4 weeks before first study drug administration
  • Has known HIV
  • Has an active infection requiring systemic treatment
  • Is participating in another therapeutic clinical trial Additional Excusion Criteria for GBM cohort:
  • Has received prior anti-VEGF therapy including bevacizumab (i.e. patients must be bevacizumab naïve)
  • Is receiving enzyme-inducing anti-epileptic drugs (EIAED). Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of PT2977

Locations:

  • University of Miami – Sylvester Comprehensive Cancer Center
  • Miami Florida 33136 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Beth Israel Deaconess Medical Center
  • Boston Massachusetts 02215 United States
  • Dana-Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Wake Forest Comprehensive Cancer Center
  • Winston-Salem North Carolina 27157 United States
  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111 United States
  • University of Pittsburgh Medical Center
  • Pittsburgh Pennsylvania 15232 United States
  • Tennessee Oncology
  • Nashville Tennessee 37203 United States
  • MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • South Texas Accelerated Research Therapeutics (START)
  • San Antonio Texas 78229 United States

View trial on ClinicalTrials.gov

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