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Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer
24 juli 2012 bijgewerkt door: Cephalon
An Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer
The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities of CEP-11981 in patients with advanced, relapsed/refractory solid tumors.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
43
Fase
- Fase 1
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Key Inclusion Criteria:
The patient:
- has a histologically or cytologically confirmed solid tumor that has relapsed or is refractory. Additionally, the tumor must be considered unresponsive or poorly responsive to accepted treatment modalities.
- has a life expectancy of at least 12 weeks.
- has an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2.
- has normal neurologic examination findings. Patients having neurologic signs and symptoms indicative of brain metastases must undergo magnetic resonance imaging (MRI) to rule out brain metastases.
- has fully recovered from any prior surgical procedure(s).
- has fully recovered from reversible side effects of prior therapy for cancer including radiation therapy, chemotherapy, and immunotherapy.
- is in appropriate health as determined by medical and psychiatric history, medical examination, electrocardiography (ECG), serum chemistry and hematology tests, and urinalysis.
- if a woman of childbearing potential (not surgically sterile or who are not 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
- if a man, not surgically sterile or who is capable of producing offspring, must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
- is willing and able to comply with study restrictions and to return to the clinic for evaluations (including follow-up).
Key Exclusion Criteria:
The patient:
- has any of the following hematologic values: absolute neutrophil count (ANC) less than 1500/mm3, platelet count less than 100000/mm3, hemoglobin less than 9 g/dL.
- has any of the following hepatic function values: bilirubin greater than 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 times the ULN in the absence of known hepatic metastases, or ALT or AST greater than 3.0 times the ULN in the presence of known hepatic metastases.
- has a serum creatinine value greater than 1.5 mg/dL.
- has known cerebral metastases.
- is currently on warfarin or heparin therapy.
- has any pre-existing coagulopathy, recent hemoptysis, gross hematuria, or gastrointestinal bleeding, and a history of a clinically significant cardiovascular or cerebrovascular event within 6 months prior to study entry.
- has uncontrolled hypertension defined as a blood pressure measurement greater than 150 mm Hg systolic or 90 mm Hg diastolic with medication.
- is receiving any other antineoplastic treatment for solid tumors. (Continuing hormonal treatment is permitted.)
- has received any investigational drug within the past 4 weeks.
- has previously been enrolled in the study or received CEP-11981.
- has known hypersensitivity to gelatin or lactose monohydrate.
- is a woman who is pregnant or lactating.
- has taken a medication known to be a potent inducer of CYP1A2, CYP2C8, or CYP3A4 within 4 weeks prior to the first dose of study drug.
- has taken a medication known to be a potent inhibitor of CYP1A2, CYP2C8, or CYP3A4 within 2 weeks prior to the first dose of study drug.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 1
At least one 6-week (42-day) cycle in which patients will be treated daily with CEP-11981 for 28 days, followed by a treatment-free period of 14 days.
|
Patients will be treated with oral CEP-11981 once daily for 28 days, followed by a treatment-free period of 14 days.
This 42-day (6-week) period will constitute 1 cycle.
The starting dose for the study will be 3 mg/m2.
Dose escalation from this starting dose follows a modified Fibonacci sequence.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of CEP-11981, as defined in the Study Protocol.
Tijdsspanne: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
|
At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Tumor response or progression using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Tijdsspanne: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
|
At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
|
Measurement of Pharmacokinetic parameters
Tijdsspanne: Cycle 1 (42 days) and Day 1 of Cycle 2
|
Cycle 1 (42 days) and Day 1 of Cycle 2
|
Safety and tolerability of CEP-11981
Tijdsspanne: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
|
At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2007
Primaire voltooiing (Werkelijk)
1 juni 2011
Studie voltooiing (Werkelijk)
1 juni 2011
Studieregistratiedata
Eerst ingediend
1 april 2009
Eerst ingediend dat voldeed aan de QC-criteria
2 april 2009
Eerst geplaatst (Schatting)
3 april 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
25 juli 2012
Laatste update ingediend die voldeed aan QC-criteria
24 juli 2012
Laatst geverifieerd
1 juli 2012
Meer informatie
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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