Status and phase
Conditions
Treatments
About
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
Full description
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
47 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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