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- Klinische proef NCT00436605
Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma
A Phase 2 Study of Dasatinib in Advanced Melanoma
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib.
II. Determine the progression-free survival of patients treated with this drug.
SECONDARY OBJECTIVES:
I. To assess the expression of targets of Dasatinib prior to treatment by obtaining pre-treatment biopsies or examining paraffin-embedded tissues from previous tumor resections.
II. In selected patients (approximately 5-10) where tumor tissue is available pre-treatment and can be obtained post-treatment with Dasatinib (21 days after initiation of therapy), to determine if Dasatinib induces changes in expression of selected targets and downstream mediators, including MEK, ERK and RSK-1.
III. To assess toxicity.
OUTLINE:
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06520
- Yale University
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55455
- Masonic Cancer Center, University of Minnesota
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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
Inclusion Criteria:
- Histologically confirmed stage III unresectable or stage IV melanoma
- Measurable disease
- Must have evidence of tumor growth or new lesions within the past 6 months
- No large pleural effusions
No known brain metastases or leptomeningeal metastases
- Previously treated brain metastases allowed provided there is no requirement for steroids AND no evidence of progression for ≥ 8 weeks after treatment
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Life expectancy > 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
- Bilirubin ≤ 1.5 mg/mL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- PT/INR and PTT normal
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
No medical condition that may affect the ability to swallow and retain dasatinib tablets, including any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication
- Requirement for IV alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
No clinically significant cardiovascular disease, including any of the following:
- Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- Prolonged QTc > 480 msec
- Major conduction abnormality (unless a cardiac pacemaker is present)
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
History of significant congenital or acquired bleeding disorder, including any of the following:
- Von Willebrand's disease
- Antifactor VIII antibodies
- Dyspnea at rest or with minimal exertion
- Uncontrolled seizure disorder
- Psychiatric illness or social situations that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active malignancy within the past 3 years except curatively treated stage I malignancies or resected skin carcinomas
- Recovered from prior therapy
- Prior adjuvant therapy for stage II or III melanoma allowed
- No prior cytotoxic therapy for metastatic melanoma
- No prior dasatinib or other inhibitors of src, bcr-abl, c-Kit, EPHA2, and PDGFRβ
- No more than 2 prior immunomodulator therapies for metastatic melanoma
- At least 1 week since prior and no concurrent warfarin or other anticoagulants or medications that inhibit platelet function (including acetylsalicylic acid)
At least 1 week since prior and no concurrent steroids or other immunosuppressive agents
- Concurrent steroids to treat induced pleural effusions allowed
At least 3 weeks since prior immunomodulators including, but not limited to, any of the following:
- Aldesleukin
- Cancer vaccines
- T-cell-activating monoclonal antibodies
At least 4 weeks since prior radiotherapy
- Prior palliative radiotherapy to a single site of disease allowed (tumor is not considered evaluable for response unless there is tumor progression at the site of radiation)
- More than 7 days since prior and no concurrent CYP3A4 inhibitors
- At least 7 days since prior and no concurrent agents with proarrhythmic potential
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- No concurrent enzyme-inducing anticonvulsant agents
- No concurrent grapefruit or grapefruit juice
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent CYP3A4 inducers
Studie plan
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 |
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Experimenteel: Treatment (kinase inhibitor therapy)
Patients receive oral dasatinib twice daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria
Tijdsspanne: After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
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Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response.
A Simon's optimum two-stage design will be used.
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After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
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Progression-free Survival
Tijdsspanne: Time from start treatment to time of progression, assessed up to 6 months
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Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee.
A Simon's optimum two-stage design will be used
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Time from start treatment to time of progression, assessed up to 6 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Harriet Kluger, Yale University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie 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
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Neuro-endocriene tumoren
- Nevi en melanomen
- Melanoma
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Proteïnekinaseremmers
- Dasatinib
Andere studie-ID-nummers
- NCI-2009-00219 (Register-ID: CTRP (Clinical Trial Reporting Program))
- CDR0000528937
- UMN-2007UC009
- YALE-HIC-0608001765
- HIC#0608001765 (Andere identificatie: Yale University)
- 7758 (Andere identificatie: CTEP)
- P30CA016359 (Subsidie/contract van de Amerikaanse NIH)
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 .
Klinische onderzoeken op Terugkerend melanoom
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National Taiwan University HospitalOnbekend
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The Netherlands Cancer InstituteOnbekendStadium IV huidmelanoom | Oog; MelanomaNederland
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University of AarhusDanish Cancer Society; AmbuFlexVoltooidMelanoma | Kwaliteit van het levenDenemarken
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Herlev HospitalVoltooidMelanoma | HuidkankerDenemarken
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Herlev HospitalVoltooidGeïntegreerde basiswetenschap binnen het instructieontwerp van patroonherkenningstraining (AISC-ISF)Melanoma | HuidkankerDenemarken
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University Medical Center GroningenWervingMelanoma | Hoofd- en nekneoplasmata | MSI-H-kankerNederland
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Vanderbilt-Ingram Cancer CenterWren Laboratories LLCVoltooidMelanomaVerenigde Staten
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Mayo ClinicActief, niet wervendMelanoma | Borstkanker | LymfoedeemVerenigde Staten
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University of UtahVoltooidMelanoma | JongvolwasseneVerenigde Staten
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WervingGlioom | Hematopoietisch en lymfoïde celneoplasma | Kwaadaardig solide neoplasma | Melanoma | SarcoomVerenigde Staten
Klinische onderzoeken op dasatinib
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Bristol-Myers SquibbVoltooidFarmacokinetische studie bij gezonde deelnemersVerenigde Staten
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Voltooid
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Hyoung Jin KangNog niet aan het wervenAcute lymfoblastische leukemie, pediatrisch
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Xspray Pharma ABQPS Bioserve India Pvt LimitedVoltooid
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National Cancer Institute (NCI)IngetrokkenHematopoietisch en lymfoïde celneoplasma | Geavanceerd lymfoom | Geavanceerd maligne solide neoplasma | Refractair lymfoom | Refractair maligne solide neoplasma | Refractair plasmacelmyeloomVerenigde Staten
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National Cancer Institute (NCI)NRG OncologyBeëindigdRecidiverend eileidercarcinoom | Recidiverend ovariumcarcinoom | Recidiverend primair peritoneaal carcinoom | Ovarieel heldercellig cystadenocarcinoom | Endometrium Clear Cell Adenocarcinoom | Terugkerende baarmoedercorpuskankerVerenigde Staten
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Jonsson Comprehensive Cancer CenterBristol-Myers SquibbVoltooid
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Peking University Cancer Hospital & InstituteOnbekendGastro-intestinale stromale tumorChina
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Voltooid
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Kanto CML Study GroupOnbekendMyelogene leukemie, chronische, chronische faseJapan