NCT01009073

A Study Evaluating ABT-263 With Erlotinib, ABT-263 With Irinotecan, and ABT-263 Monotherapy in Cancer Subjects

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-263 in Combination With Erlotinib and ABT-263 in Combination With Irinotecan, and Evaluating the Safety of ABT-263 Monotherapy in Subjects With Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a three arm study to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with erlotinib (Arm A), to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with irinotecan (Arm B), and to evaluate safety of ABT-263 monotherapy (Arm C).

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	ABT-263	ABT-263 is taken orally. Note - The dose and schedule is variable based on Arm and subject to change based on the toxicities observed.
DRUG	erlotinib	150 mg of erlotinib is taken orally once daily.
DRUG	irinotecan (3-week schedule)	180 mg/m2 over 90 minutes, irinotecan will be given by intravenous infusion on Day 1 of each 21 day cycle. Note - The dose and schedule is subject to change based on the toxicities observed.
DRUG	irinotecan (weekly schedule)	75 mg/m2 over 45 minutes, irinotecan will be given by intravenous infusion on Days 1 and 8 of each 21 day cycle. Note - The dose and schedule is subject to change based on the toxicities observed.

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2009-11-06
• Last updated: 2017-11-20

Locations

4 sites across 1 country: United States