A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Summary

The Phase I portion of this protocol will determine the best phase II dose and schedule of obatoclax with carboplatin and etoposide in patients with extensive-stage small cell lung cancer. The Phase II portion will evaluate the response rate to this regimen.

Timeline

Start

2008-05

Primary completion

2011-11

Completion

2011-11

Outcome

Missed primary endpoint

paper ORR was 62% with CbEOb versus 53% with CbE (1-sided p=0.143). PMID 24997137 ↗

paper Obatoclax was well tolerated when added to carboplatin/etoposide in first-line treatment of ES-SCLC, but failed to significantly improve ORR, PFS, or OS. PMID 24997137 ↗

Publications

• Langer CJ, Albert I, Ross HJ, Kovacs P, Blakely LJ, Pajkos G, Somfay A, Zatloukal P, Kazarnowicz A, Moezi MM, Schreeder MT, Schnyder J, Ao-Baslock A, Pathak AK, Berger MS; GEM017 Investigators. Randomized phase II study of carboplatin and etoposide with or without obatoclax mesylate in extensive-stage small cell lung cancer. Lung Cancer. 2014 Sep;85(3):420-8. doi: 10.1016/j.lungcan.2014.05.003. Epub 2014 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obatoclax	Small molecule	—	Intravenous
Background	Carboplatin	Small molecule	—	—
Background	Etoposide	Small molecule	—	—

Indications