BMS-599626 in Patients With Advanced Solid Malignancies

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095537
• Other study ID #: CA181-002
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2004
• Last updated: February 27, 2010
• Start date: March 2004

Study information

• Verified date: October 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Metastases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Local Institution	Los Angeles	California
United States	Local Institution	Scottsdale	Arizona
United States	Local Institution	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Evaluate the effect of BMS-599626 on biomarkers & predictive markers of HER1/2 in skin metabolic act. through PET imaging & preliminary evidence of anti-tumor act.,determine the effect of gastric acid modifying agents on systemic exposure of BMS-599626

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm