Clinical trial · Interventional
Ph I Dasatinib + Erlotinib in Recurrent MG
Phase I Study of Dasatinib Plus Erlotinib in Recurrent Malignant Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib and Dasatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stratum A
- description
- Pts not on EIAEDs
- interventionNames
- Drug: Erlotinib and Dasatinib
- type
- EXPERIMENTAL
- label
- Stratum B
- description
- Pts on EIAEDs
- interventionNames
- Drug: Erlotinib and Dasatinib
Primary outcomes (1)
- measure
- To determine MTD & DLT of Dasatinib when combined w Erlotinib among pts w Recurrent MG
- timeFrame
- 12 months
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available