A Trial of PT2977 Tablets In Patients With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Kidney Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:December 2016
End Date:June 2020
Contact:Richard Kelley
Email:clinicalstudies@pelotontx.com
Phone:972-629-4088

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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

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

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.

Part 2A: A cohort of 25 patients with glioblastoma (GBM)

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
We found this trial at
10
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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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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Houston, Texas 77030
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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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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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Philadelphia, Pennsylvania 19111
Phone: 215-728-3889
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San Antonio, Texas 78229
Phone: 210-593-5252
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Winston-Salem, North Carolina 27157
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