A Phase 1/2 Study Of SKI-606 In Philadelphia Chromosome Positive Leukemias

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Dose Limiting Toxicity (DLT)

Outcome Description:

DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).

Outcome Time Frame:

Part 1 Baseline up to Day 28

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3160A4-200

NCT ID:

NCT00261846

Start Date:

January 2006

Completion Date:

November 2016

Related Keywords:

• Chronic Myeloid Leukemia
• Leukemia
• tyrosine kinase inhibitor
• philadelphia chromosome
• Myeloid
• Philadelphia Positive
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Philadelphia Chromosome