Status:
COMPLETED
Ph I Dasatinib + Erlotinib in Recurrent MG
Lead Sponsor:
Duke University
Collaborating Sponsors:
Bristol-Myers Squibb
Genentech, Inc.
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 dasat...
Detailed 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 ora...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00609999
Start Date
January 1 2008
End Date
July 1 2010
Last Update
July 16 2014
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710