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A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02293980
First Posted: November 19, 2014
Last Update Posted: August 24, 2017
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.
Information provided by (Responsible Party):
Peloton Therapeutics, Inc.
  Purpose

PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD) of PT2385 Tablets and/or the recommended Phase 2 dose (RP2D) of PT2385 Tablets in patients with advanced clear cell renal cell carcinoma (ccRCC).

PART 2: The primary objective of this study is to identify the MTD of PT2385 Tablets up to the RP2D, in combination with nivolumab, in patients with advanced ccRCC.

PART 3: The primary objective of this study is to identify the MTD of PT2385 Tablets up to the RP2D, in combination with cabozantinib tablets, in patients with advanced ccRCC.


Condition Intervention Phase
ccRCC RCC Kidney Cancer Clear Cell Renal Cell Carcinoma Renal Cell Carcinoma Drug: PART 1: PT2385 Tablets Drug: PART 2: PT2385 Tablets in combination with nivolumab Drug: PART 3: PT2385 Tablets in combination with cabozantinib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multiple-Dose, Dose-Escalation Trial of PT2385 Tablets, a HIF-2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • maximum tolerated dose (MTD) [ Time Frame: PART 1: 3 Weeks, PART 2: 4 Weeks, PART 3: 4 Weeks ]

Estimated Enrollment: 107
Study Start Date: November 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: PT2385 Tablets
PART 1: Multiple Dose/Dose-Escalation
Drug: PART 1: PT2385 Tablets
PT2385 inhibits HIF-2α and is a novel approach to treatment for this patient population.
Other Name: PT2385, PT-2385, HIF-2a
Experimental: Part 2: PT2385 Tablets and nivolumab
PART 2: PT2385 Tablets in combination with nivolumab
Drug: PART 2: PT2385 Tablets in combination with nivolumab
PT2385 inhibits HIF-2α and in combination with nivolumab is a novel approach to treatment for this patient population.
Other Name: PT2385, PT-2385, HIF-2a, Opdivo
Experimental: Part 3: PT2385 and cabozantinib tablets
PART 3: PT2385 Tablets in combination with cabozantinib tablets
Drug: PART 3: PT2385 Tablets in combination with cabozantinib
PT2385 inhibits HIF-2α an upstream regulator of VEGF activation. In combination with the VEGF inhibitor cabozantinib tablets, this is a novel approach to treatment for this patient population.
Other Name: PT2385, PT-2385, HIF-2a, Cabometyx

Detailed Description:

PART 1: This is a Phase 1, multiple-dose, dose-escalation trial of PT2385 Tablets, where patients with advanced ccRCC 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 PT2385 and to assess biomarkers.

PART 2: This is a Phase 1 trial of PT2385 Tablets in combination with nivolumab, where patients with advanced ccRCC will be assigned to dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, ECGs, and hematology and chemistry laboratory studies, and by recording all AEs. Blood will be obtained for analysis of the concentration of PT2385 and to assess biomarkers.

PART 3: This is a Phase 1 trial of PT2385 Tablets in combination with cabozantinib tablets, where patients with advanced ccRCC will be assigned to dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, ECGs, and hematology and chemistry laboratory studies, and by recording all AEs. Blood will be obtained for analysis of the concentration of PT2385 and cabozantinb and to assess biomarkers.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria

PART 1

  • Has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen
  • 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

PART 2 - In addition to PART 1

  • Received no more than three prior systemic treatment regimens in the advanced or metastatic setting
  • Must have received at least one but not more than two prior anti-angiogenic therapy regimens

PART 3 - In addition to PART 1

• Must have received at least one vascular endothelial growth factor receptor (VEGFR) targeting tyrosine kinase inhibitor

Exclusion Criteria

PART 1

  • 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
  • Is receiving warfarin anticoagulant therapy or expected to require warfarin
  • 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

PART 2 - In addition to PART 1

  • Has received prior immunotherapy
  • Has any active or recent history of a known or suspected autoimmune disease

PART 3 - In addition to PART 1

  • Gastrointestinal (GI) disorders
  • Any history of congenital long QT syndrome
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293980


  Show 25 Study Locations
Sponsors and Collaborators
Peloton Therapeutics, Inc.
  More Information

Responsible Party: Peloton Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02293980     History of Changes
Other Study ID Numbers: PT2385-101
First Submitted: November 14, 2014
First Posted: November 19, 2014
Last Update Posted: August 24, 2017
Last Verified: August 2017

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