Oral ONC201 in Treating Patients With Advanced Solid Tumors

Phase 1 Completed 58 enrolled Rutgers, The State University of New Jersey National Cancer Institute (NCI) · collab Rutgers Cancer Institute of New Jersey · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of Oral ONC201 in treating patients with advanced solid tumors. Oral ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Timeline

Start: 2015-01-12
Primary completion: 2018-10-18
Completion: 2018-10-25

Outcome

Met primary endpoint

paper The primary endpoint was to determine the RP2D of weekly ONC201, which was confirmed in an 11-patient dose expansion cohort. PMID 31118108 ↗

paper The RP2D was defined as 625 mg with no DLT, treatment discontinuation, or dose modifications due to drug-related toxicity. PMID 31118108 ↗

Publications

Stein MN, Malhotra J, Tarapore RS, Malhotra U, Silk AW, Chan N, Rodriguez L, Aisner J, Aiken RD, Mayer T, Haffty BG, Newman JH, Aspromonte SM, Bommareddy PK, Estupinian R, Chesson CB, Sadimin ET, Li S, Medina DJ, Saunders T, Frankel M, Kareddula A, Damare S, Wesolowsky E, Gabel C, El-Deiry WS, Prabhu VV, Allen JE, Stogniew M, Oster W, Bertino JR, Libutti SK, Mehnert JM, Zloza A. Safety and enhanced immunostimulatory activity of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration. J Immunother Cancer. 2019 May 22;7(1):136. doi: 10.1186/s40425-019-0599-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dordaviprone	Small molecule	—	Oral