A Trial of PT2977 in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC)



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Kidney Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:September 21, 2018
End Date:September 1, 2022
Contact:Richard Kelley
Email:clinicalstudies@pelotontx.com
Phone:972-629-4088

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A Phase 2 Trial of PT2977 in Combination With Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

An open-label Phase 2 study of PT2977 in combination with cabozantinib in patients with
advanced ccRCC.

This is an open-label Phase 2 study which will evaluate the efficacy and safety of PT2977 in
combination with cabozantinib in patients with advanced ccRCC. PT2977 will be administered
orally and cabozantinib will be administered orally once daily.

Inclusion Criteria:

- Has the ability to understand and willingness to sign a written informed consent form
before the performance of any study-specific procedures

- 18 years of age or older

- Has locally advanced or metastatic RCC with predominantly clear cell subtype

- Has at least one measurable lesion as defined by RECIST version 1.1

- Eastern Cooperative Oncology Group (ECOG) 0-1

- Has adequate organ function defined as follows:

- Absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL and platelet
count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks
prior to obtaining the hematology values at screening;

- Serum creatinine level ≤ 2.0 × upper limit of normal (ULN)

- Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total
bilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease

- Cohort 1: Patients must not have received prior systemic therapy for advanced or
metastatic ccRCC

- Cohort 2: Patients must have received prior immunotherapy and no more than two prior
treatments for advanced or metastatic ccRCC

Exclusion Criteria:

- Has received prior treatment with PT2977 or other HIF2α inhibitors

- Has received prior treatment with cabozantinib

- Has had radiation therapy for bone metastases within two weeks of starting study drug

- Has a history of untreated brain metastases 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 anticoagulant therapy

- 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 3 months before first study drug administration

- Has an active infection requiring systemic treatment

- Is participating in another therapeutic clinical trial
We found this trial at
8
sites
1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
Phone: 305-243-1287
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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Miami, FL
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4100 John R
Detroit, Michigan 48201
800-527-6266
Phone: 313-576-9391
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-3713
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Seattle, Washington 98104
(206) 543-2100
Phone: 206-606-7341
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chattanooga, Tennessee 37404
Phone: 423-702-7897
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Chattanooga, TN
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Phone: 877-691-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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Seattle, Washington 98104
Phone: 206-386-9501
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Seattle, WA
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