NCT01110486

ABT-348 as Monotherapy or Combination With Carboplatin or Docetaxel to Treat Advanced Solid Tumors

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-348 as Monotherapy, in Combination With Carboplatin or in Combination With Docetaxel in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel.

Detailed description

The primary purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel. The secondary purpose of this study is to evaluate safety at the recommended Phase 2 dose and evaluate preliminary efficacy data regarding objective response rate time to progression, duration of overall response, and ECOG performance status of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ABT-348	An oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
DRUG	ABT-348 and carboplatin	An oral dose of ABT-348 will begin in Cycle 2on Day 1 and Day 8; and an IV dose of carboplatin (AUC 5.0) on Day 1 of each 21-day cycle.
DRUG	ABT-348 and docetaxel	ABT-348 dosing will begin in Cycle 2. An oral dose of ABT-348 on Day 1 and Day 8; and an IV dose of docetaxel (75 mg/m2) on Day 1 of each 21-day cycle.
DRUG	ABT-348	An oral dose of ABT-348, twice daily on Day 1, Day 8, and Day 15 of each 28 day cycle
DRUG	ABT-348	An IV administration of ABT-348 two hour infusion on Day 1, Day 8 and Day 15 of each 28 day cycle.

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-04-26
• Last updated: 2013-11-06

Locations

2 sites across 1 country: United States