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A Phase Ib Ascending Multi-arm, Dose Escalation Study of BMS-906024 Combined With Several Chemotherapy Regimens in Subjects With Advanced or Metastatic Tumors


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

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Trial Information

A Phase Ib Ascending Multi-arm, Dose Escalation Study of BMS-906024 Combined With Several Chemotherapy Regimens in Subjects With Advanced or Metastatic Tumors


Inclusion Criteria:



- Subjects with advanced or metastatic solid tumors for whom a chemotherapy regimen is
considered appropriate

- Subjects with colorectal cancer, non-small cell lung cancer, or triple-negative
breast are preferred

- Biopsy accessible tumor (may use archived tumor samples under certain circumstances)

- Life expectancy of at least 3 months

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

- Measurable disease

Exclusion Criteria:

- Uncontrolled brain metastases

- Infection

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

- Uncontrolled or significant cardiovascular disease

- Subjects 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: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety assessment based on reports of adverse events and clinical laboratory tests as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

Outcome Time Frame:

Up to 30 days after the last dose of study medication

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:

CA216-003

NCT ID:

NCT01653470

Start Date:

October 2012

Completion Date:

July 2014

Related Keywords:

  • Cancer

Name

Location
Usc Norris Cancer Hospital Laboratory Los Angeles, California  90033