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Phase I Multiple Ascending Dose Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Japanese Patients With Advanced or Metastatic Solid Tumors


Phase 1
20 Years
N/A
Not Enrolling
Both
Solid Tumors

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Trial Information

Phase I Multiple Ascending Dose Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Japanese Patients With Advanced or Metastatic Solid Tumors


Inclusion Criteria:



- Patients must have measurable disease

- Documented failure to standard therapies exist, or which are determined to be
inappropriate by the investigator

- ECOG PS: 0-1

Exclusion Criteria:

- Subjects with centrally located squamous cell carcinoma of the lung

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose Limiting Toxicity

Outcome Time Frame:

at the end of the first cycle of the study

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol Myers

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CA182-012

NCT ID:

NCT00390936

Start Date:

October 2007

Completion Date:

March 2010

Related Keywords:

  • Solid Tumors
  • Neoplasms

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