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

December, 2016

Scientific title

A Phase 1, Dose-Escalation and Expansion Trial of PT2977, a HIF-2α Inhibitor, in Patients With Advanced Solid Tumors

Summary

The primary objective of this study is 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

* 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)

Study design

Primary purpose: TREATMENT, Allocation: NON_RANDOMIZED, Intervention model: SINGLE_GROUP, Masking: NONE,

Conditions

Advanced Solid Tumors, Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, ccRCC, RCC, Clear Cell Adenocarcinoma, RCC, Kidney Cancer, Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma, Metastatic, Renal Cell Carcinoma Recurrent, Renal Cell Carcinoma, Clear Cell Adenocarcinoma, Glioblastoma, Glioblastoma, Adult, GBM, Glioblastoma Multiforme

Other study ID numbers

PT2977-101; MK-6482-001; 6482-001

Choose trial site (8)