BMS-599626 in Patients With Advanced Solid Malignancies

NCT00095537 | Completed Phase 1

• 1 other identifier: CA181-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Keywords

Solid tumors; cancer; HER-2-expressing tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Phase 1 MTD Study

EXPERIMENTAL

Drug: panHer

Interventions

panHer 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.

Also known as: BMS-599626

Phase 1 MTD Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Local Institution

Scottsdale, Arizona, United States

Location

Local Institution

Tucson, Arizona, United States

Location

Local Institution

Los Angeles, California, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

(4-((1-(3-fluorophenyl)methyl)-1H-indazol-5-ylamino)-5-methylpyrrolo(2,1-f)(1,2,4)triazin-6-yl)carbamic acid 3-morpholinylmethyl ester

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 5, 2004
• First Posted: November 8, 2004
• Study Start: March 1, 2004
• Primary Completion: May 1, 2006
• Last Updated: March 2, 2010

Record last verified: 2008-10

Locations

US (3)