Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)

NCT02060370 ↗

Phase 2 Completed 60 enrolled M.D. Anderson Cancer Center Pfizer · collab

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn more about the safety of giving sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which they receive no drug. Researchers want to learn more about the side effects of the drug and the effects of a different dosing schedule.

Timeline

Start: 2014-08
Primary completion: 2019-01-02
Completion: 2019-01-02

Outcome

Missed primary endpoint

paper The primary end point of decreased grade 3 toxicity was not met; PMID 29641297 ↗

Publications

Jonasch E, Slack RS, Geynisman DM, Hasanov E, Milowsky MI, Rathmell WK, Stovall S, Juarez D, Gilchrist TR, Pruitt L, Ornstein MC, Plimack ER, Tannir NM, Rini BI. Phase II Study of Two Weeks on, One Week off Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2018 Jun 1;36(16):1588-1593. doi: 10.1200/JCO.2017.77.1485. Epub 2018 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sunitinib	Small molecule	50 mg	Oral