This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Peloton Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Peloton Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02293980
First received: November 14, 2014
Last updated: June 12, 2017
Last verified: June 2017
  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: No masking
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: 151
Study Start Date: November 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: March 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

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
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: NCT02293980

Contacts
Contact: Richard Kelley 972-629-4081 clinicalstudies@pelotontx.com

  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
Study First Received: November 14, 2014
Last Updated: June 12, 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

ClinicalTrials.gov processed this record on June 23, 2017