A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)

Phase 2/3 Terminated 253 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin

Timeline

Start: 2007-05
Primary completion: 2008-12
Completion: 2008-12

Outcome

Missed primary endpoint

Stopped: “The study was terminated based on the recommendation by the DSMB following a pre-planned protocol interim analysis because the endpoint was not achieved.”

registry MEDIAN Vorinostat + Paclitaxel + Carboplatin: 11.0 (0.2 to 17.3) Months NCT00473889 ↗

registry MEDIAN Placebo + Paclitaxel + Carboplatin: 14.0 (0.03 to 18.7) Months NCT00473889 ↗

registry p = 0.992; Stratified Log Rank NCT00473889 ↗

Publications

Beaumont H, Souchet S, Labatte JM, Iannessi A, Tolcher AW. Changes of lung tumour volume on CT - prediction of the reliability of assessments. Cancer Imaging. 2015 Oct 31;15:17. doi: 10.1186/s40644-015-0052-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vorinostat	Small molecule	400 mg	—
Background	Carboplatin	Small molecule	—	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous