A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
- Trial number:
- NCT02974738
- Trial phase:
- 1
- Study type:
- Targeted therapy
- Overall status:
- Active, not recruiting
Study start date
Scientific title
Summary
* 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 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 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)