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Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoblastic Leukemia, Acute T-cell, Precursor T-Cell Lymphoblastic Lymphoma

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Trial Information

Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma


Inclusion Criteria:



- Subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
refractory to or relapsed from standard therapies

- Life expectancy of at least 2 months

- Performance status (PS) 0-1 (a measure of the ability to carry out activities of
daily living); subjects with PS 2 are eligible if due to disease related symptoms

- Prior anti-cancer treatment permitted (with specific criteria)

- Adequate organ function

Exclusion Criteria:

- Infection

- Elevated triglycerides

- Gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel
disease)

- Unable to tolerate bone marrow biopsy

- Taking medications known to increase risk of Torsades De Pointes (an abnormal heart
rhythm)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of subjects with adverse events as a measure of safety and tolerability

Outcome Time Frame:

Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year.

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:

CA216-002

NCT ID:

NCT01363817

Start Date:

September 2011

Completion Date:

April 2014

Related Keywords:

  • Lymphoblastic Leukemia, Acute T-cell
  • Precursor T-Cell Lymphoblastic Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Dana Farber Cancer InstituteBoston, Massachusetts  02115
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009