NCT00445198

A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies

A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Small Cell Lung Cancer or Other Non-Hematological Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose. (This portion of the study is complete). The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy.

Conditions

• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	ABT-263	Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. \- 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study. Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. \- 40 patients with SCLC

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-03-08
• Last updated: 2018-06-06

Locations

18 sites across 3 countries: United States, Canada, United Kingdom