Ph I Dasatinib + Erlotinib in Recurrent MG

Completed · Phase 1

Conditions studied: Glioblastoma, Gliosarcoma

In brief

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

Key facts

Study ID

NCT00609999

Run by

Duke University

People needed

47

Starts

2008-01-01

Expected to finish

2010-07-01

Last updated by the study team

2014-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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