BMS-599626 in Patients With Advanced Solid Malignancies

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer, Metastases

Intervention / Treatment
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* Drug: panHer


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 MTD Study<br> | Drug: panHer<br>* 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.<br>* Other names: BMS-599626;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumors, cancer, HER-2-expressing tumors