NCT00352677

Safety and Tolerability Study of INNO-406 to Treat Chronic Myeloid Leukemia or Acute Lymphocytic Leukemia

A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INNO-406 in Adult Patients With Imatinib-Resistant or Intolerant Philadelphia Chromosome-Positive (Ph+) Leukemias

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: CytRx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and effectiveness of INNO-406 in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.

Detailed description

The purpose of this study is to determine the safety, tolerability and pharmacokinetic profile of INNO-406 when administered as a daily oral agent in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.

Conditions

• Chronic Myeloid Leukemia
• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	INNO-406	Oral, twice daily self-administration of 10 mg and/or 50 mg tablets

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2006-07-17
• Last updated: 2009-06-01

Locations

6 sites across 3 countries: United States, Germany, Israel