Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors

Summary

This phase I/II trial is studying the side effects and best dose of obatoclax mesylate when given together with topotecan hydrochloride and to see how well they work in treating patients with relapsed or refractory small cell lung cancer or advanced solid tumors. Obatoclax mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with topotecan hydrochloride may help kill more tumor cells

Timeline

Start

2007-08

Primary completion

2010-08

Completion

2010-08

Outcome

Missed primary endpoint

paper There were no partial or complete responses. PMID 21620511 ↗

paper Obatoclax mesylate added to topotecan does not exceed the historic response rate seen with topotecan alone PMID 21620511 ↗

Publications

• Paik PK, Rudin CM, Pietanza MC, Brown A, Rizvi NA, Takebe N, Travis W, James L, Ginsberg MS, Juergens R, Markus S, Tyson L, Subzwari S, Kris MG, Krug LM. A phase II study of obatoclax mesylate, a Bcl-2 antagonist, plus topotecan in relapsed small cell lung cancer. Lung Cancer. 2011 Dec;74(3):481-5. doi: 10.1016/j.lungcan.2011.05.005. Epub 2011 May 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obatoclax	Small molecule	14 mg/m2	Intravenous
Background	Topotecan	Small molecule	1.25 mg/m2	Intravenous

Indications