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Status:

COMPLETED

BMS-599626 in Treating Patients With Metastatic Solid Tumors

Lead Sponsor:

Jonsson Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: BMS-599626 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-599626 in tr...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose, biologically active dose, and recommended phase II dose(s) of BMS-599626 in patients with metastatic HER2/neu-overexpressing primary solid...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed primary solid (i.e., non-hematologic) tumor
  • Radiographic or tissue confirmation of metastatic disease
  • Locally advanced disease allowed if no surgical or local therapeutic treatment exists
  • HER2/neu overexpression (1+, 2+, or 3 +) by immunohistochemistry
  • Tumors with HER2 gene amplification by fluorescence in situ hybridization analysis allowed
  • Tumor paraffin tissue block OR 20-30 unstained slides from tumor tissue block must be available for biomarker and predictive marker analyses
  • Disease progression during or after standard therapy OR no standard therapy exists
  • Measurable or non-measurable disease
  • Measurable disease is required for the expanded cohort treated at the maximum tolerated dose of the study drug
  • No known brain metastasis
  • Patients with controlled brain metastasis with no disease progression 60 days after prior therapy and no neurologic signs or symptoms are allowed
  • Patients with signs or symptoms suggestive of brain metastasis are eligible provided that brain metastasis is ruled out by CT scan or MRI
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • At least 3 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN
  • PT/PTT ≤ 1.5 times ULN
  • INR ≤ 1.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Calcium normal
  • Cardiovascular
  • LVEF ≥ 45%
  • Heart rate ≥ 50 beats/min on electrocardiogram
  • No uncontrolled cardiovascular disease
  • No myocardial infarction within the past 12 months
  • No uncontrolled angina within the past 6 months
  • No congestive heart failure within the past 6 months
  • No prolonged QTc (\> 450 msec) on electrocardiogram
  • No diagnosed or suspected congenital long QT syndrome
  • No history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
  • No history of second- or third-degree heart block
  • Patients with pacemakers may be eligible
  • No uncontrolled hypertension
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study participation
  • Potassium normal
  • Magnesium normal
  • No medical condition that has a risk of causing torsades de pointes
  • No active infection
  • No serious uncontrolled medical disorder that would preclude study participation
  • No dementia or altered mental status that would preclude giving informed consent
  • No known allergy to BMS-599626 or related compound
  • No prisoners or patients involuntarily incarcerated for treatment of either a psychiatric or physical (e.g., infectious disease) illness
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • At least 4 weeks since prior immunotherapy
  • At least 2 weeks since prior targeted kinase inhibitor (e.g., trastuzumab \[Herceptin\^®\])
  • Chemotherapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome)
  • Endocrine therapy
  • At least 2 weeks since prior anticancer hormonal therapy
  • Radiotherapy
  • At least 4 weeks since prior radiotherapy
  • Surgery
  • Not specified
  • Other
  • Recovered from prior therapy
  • Prior adjuvant or neoadjuvant therapy allowed
  • No short-acting antacids (e.g., Maalox\^® or TUMS\^®) 8 hours before or 4 hours after study drug administration
  • No recent anticancer therapy
  • More than 4 weeks since prior investigational agents
  • At least 5 days (or 5 half-lives) since prior drugs that cause torsades de pointes
  • At least 48 hours since prior proton pump inhibitors (e.g., omeprazole or lansoprazole) or histamine H\_2 antagonists (e.g., ranitidine, famotidine, or cimetidine)
  • Concurrent low-dose coumadin allowed
  • No other concurrent investigational agents
  • No concurrent drugs that may cause torsades de pointes or QTc prolongation

Exclusion

    Key Trial Info

    Start Date :

    August 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    9 Patients enrolled

    Trial Details

    Trial ID

    NCT00093730

    Start Date

    August 1 2004

    Last Update

    October 4 2012

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781