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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Chronic Myeloid Leukemia

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Trial Information

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

Inclusion Criteria:

- Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have
disease progression/relapse while on full-dose imatinib, or are intolerant of any
dose of imatinib.

- At least 3 months post stem cell transplantation

- Able to take daily oral capsules/tablets reliably

Exclusion Criteria:

- Subjects with Philadelphia chromosome, and bcr-abl negative CML

- Overt leptomeningeal leukemia

- Subjects without evidence of leukemia in bone marrow (extramedullary disease only)

Type of Study:


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:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




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



Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Washington, District of Columbia  20007-2197