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A Trial of PT2977 Tablets In Patients With Advanced Solid Tumors

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Peloton Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Peloton Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02974738
First received: November 23, 2016
Last updated: December 22, 2016
Last verified: December 2016
  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

Condition Intervention Phase
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 Drug: PT2977 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multiple-Dose, Dose-Escalation and Expansion Trial of PT2977, a HIF-2α Inhibitor, in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Peloton Therapeutics, Inc.:

Primary Outcome Measures:
  • maximum tolerated dose (MTD) [ Time Frame: 3 Weeks ]
    21-Day Dose Limiting Toxicity Observation Period per Dose Group


Estimated Enrollment: 125
Study Start Date: December 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1A

Drug: PART 1A: PT2977 for the treatment of advanced solid tumors

PT2977 inhibits HIF-2α and is a novel approach to treatment of solid tumors.

Drug: PT2977
PT2977 is a highly selective small molecule that inhibits the function of the HIF-2α transcription factor. As a result, hypoxic signaling in cancer cells is impaired, blocking the transcription of several genes involved in oncogenesis
Other Name: PT2977 Tablets, PT-2977, HIF-2α
Experimental: Part 1B

Drug: PART 1B: PT2977 for the treatment of advanced ccRCC

PT2977 inhibits HIF-2α and is a novel approach to treatment of ccRCC.

Drug: PT2977
PT2977 is a highly selective small molecule that inhibits the function of the HIF-2α transcription factor. As a result, hypoxic signaling in cancer cells is impaired, blocking the transcription of several genes involved in oncogenesis
Other Name: PT2977 Tablets, PT-2977, HIF-2α
Experimental: Part 2

Part 2: PT2977 for the treatment of other specified solid tumors

PT2977 inhibits HIF-2α and is a novel approach to treatment of specified solid tumors.

Drug: PT2977
PT2977 is a highly selective small molecule that inhibits the function of the HIF-2α transcription factor. As a result, hypoxic signaling in cancer cells is impaired, blocking the transcription of several genes involved in oncogenesis
Other Name: PT2977 Tablets, PT-2977, HIF-2α

Detailed Description:

Part 1A: This is a Phase 1, multiple-dose, dose-escalation trial of PT2977 Tablets, where patients with advanced solid tumors will be assigned to sequential dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, electrocardiograms (ECGs), and hematology and chemistry laboratory studies, and by recording all adverse events (AEs). Blood will be obtained for analysis of the concentration of PT2977 and to assess biomarkers.

Part 1B: Once the MTD and/or the RP2D is achieved, and expansion cohort of 25 patients with advanced clear cell renal cell carcinoma (ccRCC) will be enrolled.

Part 2: After determination of the MTD/RP2D, up to 25 patients with other specified solid tumors may be enrolled. Up to 3 different tumor types may be included in this part of the study.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a diagnosis of locally advanced or metastatic solid tumor
  • Is of age ≥ 18 years
  • Has a life expectancy of ≥ 3 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02974738

Contacts
Contact: Richard Kelley 972-629-4088 clinicalstudies@pelotontx.com

Locations
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact    877-691-7274      
United States, Texas
South Texas Accelerated Research Therapeutics (START) Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez, RN, MSN    210-593-5252      
Contact       Isabel.Jimenez@start.stoh.com   
Sponsors and Collaborators
Peloton Therapeutics, Inc.
  More Information

Responsible Party: Peloton Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02974738     History of Changes
Other Study ID Numbers: PT2977-101
Study First Received: November 23, 2016
Last Updated: December 22, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Adenocarcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma, Clear Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 22, 2017