Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Ph I Dasatinib + Erlotinib in Recurrent MG

15 luglio 2014 aggiornato da: Duke University

Phase I Study of Dasatinib Plus Erlotinib in Recurrent Malignant Glioma

Primary:

To determine maximum tolerated dose & dose limiting toxicity of dasatinib when combined w erlotinib among pts w recurrent MG

Secondary:

To further evaluate safety & tolerability of dasatinib + erlotinib To evaluate pharmacokinetics of dasatinib when administered w erlotinib among recurrent MG pts who are on & not on CYP-3A enzyme inducing anti-epileptic drugs To evaluate for anti-tumor activity with this regimen in this patient population

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

Tarceva administered on continuous oral dosing schedule at 150 mg/day for pts not on EIAEDs & 450 mg/day for pts on EIAEDs. Starting dose level of dasatinib will be 100 mg once day via continuous oral daily dosing. Dasatinib will be increased in successive cohorts of enrolled pts. Pts will remain on treatment until excessive toxicity, progressive disease, withdrawal of consent/death.

Pts have confirmed diagnosis of recurrent/progressive WHO gr IV MG / WHO grade III MG. Phase I 3+3 dose escalation design w 2 independently escalated stratum: stratum A-pts not on CYP3A-enzyme inducing anti-epileptic drugs; stratum B-pts on EIAEDs. Assessment of safety will be based mainly on frequency of adverse events, particularly adverse events leading to discontinuation of treatment & on number of significant lab abnormalities.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

47

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Health System

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Diagnosis of recurrent/progressive WHO grade IV MG or WHO grade III MG. Pts with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO grade III / IV MG
  • >18 yrs
  • Karnofsky Performance Status >70 percent
  • Pts presenting in 1st, 2nd / 3rd relapse. Prior therapy must have included external beam XRT
  • Adequate bone marrow, liver & renal function as assessed by following:
  • Hemoglobin>9.0g/dl
  • ANC>1,500/mm3
  • Platelet count>100,000/mm3
  • Total bilirubin<1.5 x ULN
  • ALT & AST<2.5 x ULN
  • INR<1.5 or PT/PTT within normal limits. Pts receiving anti-coagulation treatment w low-molecular weight heparin allowed to participate, oral warfarin is not permitted
  • Creatinine<1.5 x ULN
  • Serum Na, K+, Mg2+, Phosphate & Ca2+ >LLN
  • Interval<2 wks between prior surgical resection & initiation of study regimen
  • Interval <12 weeks from completion of standard, daily XRT, unless one of following occurs: new area of enhancement on MRI imaging that is outside XRT field; biopsy proven recurrent tumor; / radiographic evidence of progressive tumor on 2 consecutive scans >4 wks apart.
  • Interval <4weeks from prior chemotherapy unless there is unequivocal evidence of tumor progression & pt has recovered from all anticipated toxicities from prior therapy
  • Interval <4weeks from prior investigational agent unless there is unequivocal evidence of tumor progression & pt has recovered from all anticipated toxicities from prior therapy
  • Signed written informed consent including HIPAA according to institutional guidelines. Signed informed consent must be obtained prior to any study specific procedures
  • If sexually active, pts will take contraceptive measures for duration of treatments & for 4 weeks following discontinuation of dasatinib & Erlotinib.
  • Women of childbearing potential must have negative serum or urine pregnancy test within 72 hrs prior to start of study drug administration

Exclusion Criteria:

  • No prior dasatinib / oral EGFR-inhibitor therapy
  • Pregnancy/breast feeding
  • History of significant concurrent illness

    ->3 prior episodes of progressive disease

  • Significant cardiac disease
  • Excessive risk of bleeding as defined by stroke <6 months, history of CNS / intraocular bleed,/ septic endocarditis.
  • Concurrent severe and/or uncontrolled medical disease that could compromise participation in study including any of following: pleural / pericardial effusion of any grade; uncontrolled diabetes; uncontrolled hypertension; active clinically serious infection >CTCAEv3 Gr2 requiring active intervention; history of clinically-significant bleeding diathesis or coagulopathy including platelet function disorder or acquired bleeding disorder within 1yr; impairment of GI function /GI disease that may significantly alter absorption of study regimen; ongoing or recent significant gastrointestinal bleeding
  • Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks <6 months
  • Any hemorrhage/bleeding event >CTCAEv3AE Gr3 within 4wks of 1st dose of study drug
  • Serious non-healing wound, ulcer, /bone fracture
  • Major surgery, open biopsy /significant traumatic injury <4 weeks of 1st study drug
  • Known HIV infection/chronic Hepatitis B/C
  • Pt is <3yrs free of another primary malignancy except: if other primary malignancy is either not currently clinically significant/does not require active intervention. Existence of any other malignant disease is not allowed.
  • Pts unwilling to/unable to comply with protocol including ability to swallow whole pills/presence of any malabsorption syndrome
  • Concurrent administration of warfarin, rifampin/St. John's Wort
  • Subjects w hypokalemia/hypomagnesemia if it cannot be corrected
  • Prisoners/subjects who are compulsorily detained for treatment of either psychiatric/physical illness

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Stratum A
Pts not on EIAEDs
You will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected & will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 & at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib & Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib & Erlotinib given daily for 28 days for purpose of scheduling evaluations.
Altri nomi:
  • Tarceva
  • Sprycel
  • Erlotinib
  • Dasatinib
Sperimentale: Stratum B
Pts on EIAEDs
You will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected & will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 & at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib & Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib & Erlotinib given daily for 28 days for purpose of scheduling evaluations.
Altri nomi:
  • Tarceva
  • Sprycel
  • Erlotinib
  • Dasatinib

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
To determine MTD & DLT of Dasatinib when combined w Erlotinib among pts w Recurrent MG
Lasso di tempo: 12 months
12 months

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
To further evaluate safety & tolerability of Dasatinib + Erlotinib
Lasso di tempo: 12 months
12 months
To evaluate the PK of Dasatinib when administered w Erlotinib among Recurrent MG pts who are on & not on EIAEDs
Lasso di tempo: 12 months
12 months
To evaluate for anti-tumor activity w this regimen in this pt population
Lasso di tempo: 12 months
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2008

Completamento primario (Effettivo)

1 luglio 2010

Completamento dello studio (Effettivo)

1 luglio 2010

Date di iscrizione allo studio

Primo inviato

25 gennaio 2008

Primo inviato che soddisfa i criteri di controllo qualità

25 gennaio 2008

Primo Inserito (Stima)

7 febbraio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 luglio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2014

Ultimo verificato

1 aprile 2012

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi