NCT00397293

Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer

An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ascenta Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer

Detailed description

Further Study Details provided by Ascenta:

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AT-101	40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
DRUG	topotecan	40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-11-09
• Last updated: 2010-08-24

Locations

19 sites across 3 countries: United States, Russia, Ukraine