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- Klinische proef NCT00004877
BMS-214662 in Treating Patients With Advanced Solid Tumors
Phase I Study of BMS-214662 Oral Dosing in Patients With Advanced Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of BMS-214662 in treating patients who have advanced solid tumors.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended phase II dose, and safety of BMS-214662 in patients with advanced solid tumors. II. Determine the pharmacokinetics of BMS-214662 in these patients. III. Assess the absolute oral bioavailability of BMS-214662 using a capsule and single intravenous dose in these patients. IV. Determine any preliminary evidence of antitumor activity of BMS-214662 in these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-214662 IV over 1 hour on day -7, followed by oral BMS-214662 daily on days 0-14 for course 1 only. Beginning with course 2, patients receive oral BMS-214662 twice daily for 14 days. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 2 of 6 patients experience dose limiting toxicity. Patients are followed every 4 weeks until toxicities resolve.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 12-18 months.
Studietype
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan-Kettering Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumor that is refractory to standard therapy or for which no effective therapy exists No active brain metastases including evidence of cerebral edema by CT or MRI scan, progression from prior imaging study, any requirement for steroids, or clinical symptoms
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL ALT and AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Cardiovascular: No uncontrolled or significant cardiac disease No myocardial infarction within the past 6 months No congestive heart failure (with or without therapy) No history of atrial or ventricular arrhythmias No history of second or third degree heart block No prolonged QTc interval on electrocardiogram Pulmonary: No uncontrolled or significant pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious uncontrolled medical disorder or active infection No dementia or altered mental status No prior or concurrent gastrointestinal disease within past 6 months No history of malabsorption No impaired oral ingestion (e.g., patients with feeding tubes)
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy (except replacement hormone therapy) Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of the bone marrow No concurrent radiotherapy Surgery: No prior surgery that would impact the absorption of BMS-214662 Other: At least 4 weeks since prior investigational agents No other concurrent experimental anticancer medications No prior CYP3A4 substrates within 1 week before, during, and for at least 1 week after study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- CDR0000067537
- MSKCC-99045
- BMS-CA158-004
- NCI-G00-1671
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Klinische onderzoeken op BMS-214662
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National Cancer Institute (NCI)VoltooidNiet-gespecificeerde solide kindertumor, protocolspecifiek | Niet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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National Cancer Institute (NCI)VoltooidNiet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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National Cancer Institute (NCI)VoltooidTerugkerende volwassen acute myeloïde leukemie | Volwassen acute promyelocytische leukemie (M3) | Myelodysplastische syndromen bij kinderen | Eerder behandelde myelodysplastische syndromen | Terugkerende volwassen acute lymfoblastische leukemie | Terugkerende acute lymfoblastische leukemie... en andere voorwaardenVerenigde Staten
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National Cancer Institute (NCI)VoltooidNiet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)VoltooidNiet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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Bristol-Myers SquibbVoltooid
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Bristol-Myers SquibbVoltooidMultiple sclerose (MS)Verenigde Staten, Verenigd Koninkrijk
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Bristol-Myers SquibbVoltooidHartdecompensatie, acuutVerenigde Staten
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Bristol-Myers SquibbVoltooidGezonde vrijwilligersVerenigde Staten
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Bristol-Myers SquibbBeëindigdSyndroom van SjogrenAustralië, Verenigde Staten, Italië, Mexico, Colombia, Peru, Puerto Rico, Zuid-Afrika, Chili, Polen, Russische Federatie