NCT00649207

A Phase I Study of ABT-888 in Combination With Conventional Whole Brain Radiation Therapy (WBRT) in Cancer Patients With Brain Metastases

A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of ABT-888 in Combination With Whole Brain Radiation Therapy in Subjects With Brain Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain metastases.

Detailed description

This is a Phase 1, multicenter, dose-escalation study evaluating the safety, tolerability and pharmacokinetics of the PARP inhibitor ABT-888 in combination with conventional whole brain radiation therapy (WBRT) in the treatment of subjects with solid tumors metastatic to the brain.

Conditions

• Brain Diseases
• Brain Neoplasms
• Central Nervous System Diseases
• Neoplasm Metastasis
• Nervous System Neoplasms

Interventions

Type	Name	Description
DRUG	ABT-888	Oral Capsules
RADIATION	Whole Brain Radiation Therapy	15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy

Timeline

• Start date: 2008-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2008-04-01
• Last updated: 2017-11-21

Locations

9 sites across 3 countries: United States, Canada, Puerto Rico