BMS-599626 in Treating Patients With Metastatic Solid Tumors

NCT00093730 | Completed Phase 1

• 3 other identifiers: CDR0000389510UCLA-0404066-01BMS-CA181002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 treating patients with metastatic solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose of BMS-599626

  28 days

Study Arms (1)

BMS-59926

EXPERIMENTAL

Drug: BMS-59926

Interventions

BMS-59926 DRUG

BMS-59926

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Study Officials

• Mark D. Pegram, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: August 1, 2004
• Primary Completion: April 1, 2006
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

US (1)