BMS-599626 in Patients With Advanced Solid Malignancies

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Metastases

Cancer

Treatments

Drug: panHer

Study type

Interventional

Funder types

Industry

Identifiers

NCT00095537

CA181-002

Details and patient eligibility

About

The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21 days with a 7 day rest period in patients with cancer who no longer benefit from other commonly used treatments. The study will also test for other proteins that may be affected by BMS-599626; and the level of study drug in the blood will be studied.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)