BMS-599626 in Patients With Advanced Solid Malignancies

NCT ID: NCT00095537

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31

Brief Summary

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.

Conditions

Cancer; Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 MTD Study

Group Type: EXPERIMENTAL

panHer

Intervention Type: DRUG

Tablets, Oral, A modified Fibonocci dose escalation system initiated at 100mg and escalating up to 880mg maximum dose (rounded down to 20mg increments based on smallest tablet size); -2 40mg -33%; -1 60mg -40%; 1 100mg --; 2 200mg 100%; 3 320mg 67%; 4 480mg 50%; 5 660mg 40%; 6 880mg 33.3%, Daily, Until DLT or study MTD is reached.

Interventions

panHer

Tablets, Oral, A modified Fibonocci dose escalation system initiated at 100mg and escalating up to 880mg maximum dose (rounded down to 20mg increments based on smallest tablet size); -2 40mg -33%; -1 60mg -40%; 1 100mg --; 2 200mg 100%; 3 320mg 67%; 4 480mg 50%; 5 660mg 40%; 6 880mg 33.3%, Daily, Until DLT or study MTD is reached.

Intervention Type: DRUG

Other Intervention Names

BMS-599626

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Locations

Local Institution

Scottsdale, Arizona, United States

Local Institution

Tucson, Arizona, United States

Local Institution

Los Angeles, California, United States

Countries

United States

Other Identifiers

CA181-002

Identifier Type: -

Identifier Source: org_study_id