Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors

Summary

This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors that have spread to other places in the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and gemcitabine hydrochloride may work better in treating patients with solid tumors.

Timeline

Start

2018-01-04

Primary completion

2022-05-17

Completion

2022-05-17

Publications

• Norman A, Seetharam M, Allred J, Kong J, Opyrchal M, Ma WW, Lou Y, Dy GK, Mahipal A, Weroha SJ, Wahner Hendrickson AE, Reid JM, Adjei AA. A phase I study of the CDK4/6 inhibitor ribociclib combined with gemcitabine in patients with advanced solid tumors. BJC Rep. 2025 Jan 14;3(1):1. doi: 10.1038/s44276-024-00107-0.
• Seetharam M, Norman A, Allred J, Kong J, Opyrchal M, Ma WW, Lou Y, Dy GK, Mahipal A, Weroha J, Wahner-Hendrickson A, Reid JM, Adjei AA. A Phase I Study of sequences of the CDK4/6 Inhibitor, Ribociclib Combined with Gemcitabine in Patients with Advanced Solid Tumors. Res Sq [Preprint]. 2024 Apr 25:rs.3.rs-4261257. doi: 10.21203/rs.3.rs-4261257/v1.

Drugs

Indications