A Phase I, Multiple-Dose, Dose-Escalation and Expansion Trial of PT2977, a HIF-2alpha Inhibitor, in Patients With Advanced Solid Tumors
Study Identifier:
PT2977-101-MK-6482-001
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Study Complete
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Study Summary
To identify the maximum tolerated dose (MTD) of belzutifan Tablets and/or the recommended Phase 2 dose (RP2D) of belzutifan Tablets in patients with advanced solid tumors
To evaluate safety, pharmacokinetics (PK) and pharmacodynamics (PD).
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female & Male
Age
18+ years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Study Complete
Requirements information
Inclusion criteria
- Has a diagnosis of locally advanced or metastatic solid tumor
- Is of age > or = 18 years
- Has a life expectancy of > or = 6 months
- Has adequate organ function
- If a female patient, must not be pregnant or breastfeeding and not a woman of childbearing potential (WOCBP) OR a WOCBP who uses contraception or is abstinent from heterosexual intercourse during the study and for a minimum of 30 days after the last study drug administration, or if a male patient, must be abstinent from heterosexual intercourse OR agree to use contraception
- 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
- Must have recovered from prior therapy to grade =1 severity (except for alopecia and lymphocytopenia) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
- Patients enrolled in the GBM cohort had histologically confirmed, IDH wild type GBM that is first recurrent following radiation therapy and temozolomide according to the Response Assessment in Neuro-Oncology (RANO) criteria and had a measurable contrast-enhancing lesion by MRI imaging and a Karnofsky performance scale score ≥60%.
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 (does not apply to GBM cohort)
- 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 belzutifan
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Kyriakos Papadopoulos
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Solid Carcinoma
Renal
Female genital organs
Brain