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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
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:

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

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteWashington, District of Columbia  20007-2197