BMS-599626 in Patients With Advanced Solid Malignancies

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095537

Enrollment

Registered

2004-11-08

Start date

2004-03-31

Completion date

Unknown

Last updated

2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Metastases

Keywords

Solid tumors, cancer, HER-2-expressing tumors

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.

Interventions

DRUGpanHer

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	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

Measure	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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026