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A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Advanced and/or Metastatic Solid Tumors


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Solid Cancers, Metastatic Cancer

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Trial Information

A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Advanced and/or Metastatic Solid Tumors


Phase 1

Inclusion Criteria:



- Subjects with advanced and/or metastatic solid tumors who are either refractory to or
have relapsed from standard therapies, or for whom a standard therapy does not exist.

- ECOG performance status ≤ 2

- Accessible for treatment, PK sample collection and required study follow-up

- Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 2.5 x ULN

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Subjects with known or suspected brain metastasis, primary brain tumors, or brain as
the only site of disease

- Exposure to any investigational agent within 4 weeks of study drug administration

- Subjects a history of gastrointestinal disease

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:

Determine maximum tolerated dose and anti-tumor activity of BMS-863233 when administered to subjects with advanced and/or Metastatic solid tumors

Outcome Time Frame:

Every 28 days until the MTD is reached

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:

CA198-002

NCT ID:

NCT00886782

Start Date:

May 2009

Completion Date:

August 2010

Related Keywords:

  • Advanced Solid Cancers
  • Metastatic Cancer
  • Advanced and/or Metastatic solid cancers
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Karmanos Cancer InstituteDetroit, Michigan  48201