Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1

Phase 1 Completed 53 enrolled G1 Therapeutics, Inc.

RandomizedSingle-groupDouble-blindOther

Summary

This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.

Timeline

Start: 2014-09
Primary completion: 2015-02
Completion: 2015-12-18

Publications

Li C, Hart L, Owonikoko TK, Aljumaily R, Rocha Lima CM, Conkling PR, Webb RT, Jotte RM, Schuster S, Edenfield WJ, Smith DA, Sale M, Roberts PJ, Malik RK, Sorrentino JA. Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer. Cancer Chemother Pharmacol. 2021 May;87(5):689-700. doi: 10.1007/s00280-021-04239-9. Epub 2021 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	G1T28-1	Unknown	6 mg/m2	Intravenous

Indications

No indication recorded.