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An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).


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

Thank you

Trial Information

An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).


1. Design:

Study Design and Duration as current described are no longer applicable since
enrollment was prematurely concluded due to a decision by the sponsor. Subjects
currently enrolled in the trial will continue to receive dasatinib alone at a starting
dose of 100 mg QD for:

1. a maximum of 5 years after entry into the study

2. until progression by Investigators determination/judgment

3. intolerance to Dasatinib

4. the study is terminated due to safety concerns or

5. other administrative reasons as communicated by the sponsor

2. Research Hypothesis :

The research hypothesis and primary objective of this study as originally designed are no
longer applicable as subjects enrolment has been terminated due to administrative reasons by
the sponsor. The objective of the altered design of this study is to describe the safety
profile and tolerability of dasatinib


Inclusion Criteria:



- Subjects ≥ 18 years of age who have signed informed consent

- Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase

- Previously untreated chronic phase CML, except for Anagrelide or Hydroxyurea.

- Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2

Exclusion Criteria:

- Known Abl-kinase T315I or T315A mutation

- Serious or uncontrolled medical disorder (including infection or cardiovascular
disease) or dementia or other serious psychiatric condition

- Prior chemotherapy.

- Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP)
who are unwilling or unable to use an acceptable method to avoid pregnancy during the
entire study period.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare Major Molecular Response (MMR) rates for dasatinib alone versus dasatinib combined with SMO-antagonist in newly diagnosed Chronic Phase (CP) CML subjects (who did not achieve MMR within 1 year of treatment with dasatinib alone).

Outcome Time Frame:

Within 18 months from start of treatment

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-363

NCT ID:

NCT01357655

Start Date:

September 2011

Completion Date:

May 2017

Related Keywords:

  • Leukemia
  • Myelogenous
  • Chronic
  • BCR-ABL Positive
  • Leukemia
  • Philadelphia Chromosome

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112
University of Texas Southwestern Medical Center at DallasDallas, Texas  75235-8897
Tennessee Oncology, PLLCClarksville, Tennessee  37043
The University Of Texas - M.D. Anderson Cancer CenterHouston, Texas  77030
John Theurer Cancer CenterHackensack, New Jersey  07601
Oncology Hematology Care, IncorporatedCincinnati, Ohio  45248