- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00609999
Ph I Dasatinib + Erlotinib in Recurrent MG
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
Condizioni
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
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
North Carolina
-
Durham, North Carolina, Stati Uniti, 27710
- Duke University Health System
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
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:
|
|
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:
|
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
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie, ghiandolari ed epiteliali
- Astrocitoma
- Glioma
- Neoplasie, Neuroepiteliali
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Glioblastoma
- Gliosarcoma
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Erlotinib cloridrato
- Dasatinib
Altri numeri di identificazione dello studio
- Pro00002272
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 .