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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 Advanced Solid Tumors


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

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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 Advanced Solid Tumors


Inclusion Criteria:



- Subjects with advanced or metastatic solid tumors (non-hematologic) refractory to or
relapsed from standard therapies or for which there is no know effective treatment
during dose escalation.

- Subjects with colorectal cancer, non-small cell lung cancer, triple-negative breast
or other solid tumor types for which Notch activation has been demonstrated (such as
pancreatic, ovarian and melanoma) during dose expansion

- Biopsy accessible tumor (may be waived under certain circumstances)

- Life expectancy of at least 3 months

- Eastern Cooperative Oncology Group (ECOG) 0-1

- Adequate organ and bone marrow function

Exclusion Criteria:

- Infection

- Elevated triglycerides

- Gastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory
bowel disease (IBD))

- Taking medications known to increase risk of Torsades De Pointes

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 event as well as an assessment 30 day 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:

CA216-001

NCT ID:

NCT01292655

Start Date:

March 2011

Completion Date:

February 2015

Related Keywords:

  • Cancer

Name

Location

Wayne State UniversityDetroit, Michigan  48202
Local InstitutionAustin, Texas  
Local InstitutionJackson, Mississippi  
Anthony El-Khoueiry, MdLos Angeles, California  90033