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Phase I Study of BMS-599626 in Patients With Advanced Solid Malignancies, Including Malignancies That Express HER2 at the Maximum Tolerated Dose and/or Recommended Phase II Dose


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer, Metastases

Thank you

Trial Information

Phase I Study of BMS-599626 in Patients With Advanced Solid Malignancies, Including Malignancies That Express HER2 at the Maximum Tolerated Dose and/or Recommended Phase II Dose


Inclusion Criteria:



- Diagnosis of metastatic cancer that has progressed on currently available therapies;

- At least 3 month life expectancy;

- Primary cancer must be solid (non-hematologic);

- Adequate bone marrow, liver & kidney function;

- Negative pregnancy test.

Exclusion Criteria:

- Serious, uncontrolled medical disorder;

- Individuals not willing or able to use an acceptable method to avoid pregnancy for
the entire study period and for at least 3 months after the study;

- Pregnant or breastfeeding women;

- Patients with known brain metastasis;

- Uncontrolled or significant cardiovascular disease;

- Anticancer therapy within 2-6 weeks prior to study drug (depending on the therapy)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Det. the max tolerated dose,biologically active doses & recommended phase 2 dose of BMS-599626 when adm. as a daily oral dose to pts with HER2 expressing-metastatic solid tumors who have progressed on or following standard therapy

Authority:

United States: Food and Drug Administration

Study ID:

CA181-002

NCT ID:

NCT00095537

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Cancer
  • Metastases
  • Solid tumors
  • cancer
  • HER-2-expressing tumors
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Local InstitutionPhoenix, Arizona  
Local InstitutionCorona, California