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Dasatinib (BMS-354825) Combined With SMO Inhibitor (BMS-833923; XL139) in CML With Resistance or Suboptimal Response to a Prior TKI


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Dasatinib (BMS-354825) Combined With SMO Inhibitor (BMS-833923; XL139) in CML With Resistance or Suboptimal Response to a Prior TKI


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Key

Inclusion Criteria:



- Subjects ≥ 18 years of age

- Chronic myeloid leukemia (CML) in chronic or advanced phase (including Ph+ALL) with
progression/failure during or suboptimal response to imatinib, nilotinib or dasatinib
(see protocol for details)

- Performance Status 0-1 with resolution of toxicity from prior therapy

Key Exclusion Criteria:

- Known Abl-kinase T315I or T315A mutation

- Laboratory abnormalities:

- Uncorrected serum calcium or phosphate below institutional LLN

- Amylase or lipase Grade ≥1

- Blood count values Grade ≥3

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

- Women who are pregnant or breastfeeding or WOCBP who are unwilling or unable to use
an acceptable method to avoid pregnancy during the entire study period

- Must be ≥6 months after stem cell transplantation

- Sexually active fertile men (with partners that are WOCBP) not using effective birth
control for duration of study and for at least 3 months following combination
treatment.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary endpoint is identification of a recommended Phase 2 dose (RP2D) for BMS-833923 plus dasatinib in subjects with chronic phase CML

Outcome Time Frame:

Approximately 120 weeks

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-323

NCT ID:

NCT01218477

Start Date:

January 2011

Completion Date:

April 2013

Related Keywords:

  • Leukemia
  • Leukemia
  • (CML- Chronic Phase and Advanced)
  • Leukemia

Name

Location

UT M.D. Anderson Cancer CenterHouston, Texas  77030
Sidney Kimmel Cancer Center At Johns HopkinsBaltimore, Maryland  21231
University of California Medical CenterSan Francisco, California  94143