Clinical trial · Interventional
Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent Malignant Glioma
Phase I Study of Zactima (ZD6474) Plus Imatinib Mesylate and Hydroxyurea for Patients With 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 Objective To determine maximum tolerated dose \& dose limiting toxicity of Zactima when combined w standard dosing of imatinib mesylate \& hydroxyurea among pts w recurrent malignant glioma who are on \& not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety \& tolerability of Zactima + imatinib mesylate \& hydroxyurea To evaluate pharmacokinetics of Zactima among MG pts on \& not on enzyme inducing anti-epileptic drugs (EIAEDs) when combo w imatinib mesylate \& hydroxyurea To evaluate pharmacokinetics of imatinib mesylate among MG pts on \& not on EIAEDs when combo w Zactima \& hydroxyurea Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among recurrent malignant glioma (RMG) pts including radiographic response rate, 6-month progression free survival (PFS) rate \& median PFS
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 |
|---|---|---|---|
| Zactima, Gleevec, Hydroxyurea | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zactima + Gleevec + Hydrea
- interventionNames
- Drug: Zactima, Gleevec, Hydroxyurea
Primary outcomes (1)
- measure
- To determine MTD & dose-limiting toxicity (DLT) & Zactima when combo w Imatinib mesylate & Hydroxyurea among pt w Recurrent MG
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- To further assess safety & tolerability of Zactima & Imatinib mesylate & Hydroxyurea
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pts have baseline evaluations performed ≤14days prior to 1st dose of study drug unless otherwise specified. Written informed consent must be obtained from pt prior to enrollment * Pts w MG who are presenting in 1st, 2nd or 3rd recurrence or relapse * Pts may not have tumor biopsy \<1 wk or surgical resection \<2wks * For stratum of non-EIAED pts, each pt be off all EIAEDs for \>2 wks prior to starting study drug; similarly for stratum of EIAED pts, each pt be on EIAED for \>2 wks prior to starting study drug * Pts should be on non-increasing dose of steroids for \>7 days prior to obtaining baseline Gd-MRI of brain * Pts should be on non-increasing dose of steroids for \>7 days prior to starting study drug * Multifocal disease is eligible * Age \>18yrs * Karnofsky Performance Status (KPS) of \>70 * Absolute neutrophil count (ANC) \> 1.0 x 10 9/L * Hgb\>g/dL * Platelets\>100 x 10 9/L * Serum creatinine\<1.5 x upper limit of normal (ULN)/measured 24hr creatinine clearance (CrCl) \>50 milliliters/min/1.73m * Life ≥12wks * Written informed consent obtained prior to any screening procedures Exclusion Criteria: * Serum bilirubin \>1.5x ULN of reference range * Serum creatinine \>1.5 x Upper Limit of the Reference Range (ULRR)/CrCl \<50 milliliters/min * K\<4.0 mmol/L despite supplementation; serum Ca/Mg out of normal range despite supplementation * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 x ULRR * Evidence of severe/uncontrolled systemic disease or any concurrent condition which in Investigator's opinion makes it undesirable for pt to participate in trial or which would jeopardize compliance w protocol * Clinically significant cardiac event such as myocardial infarction; New York Heart Association (NYHA) classification of heart disease \>2 within 3 months before entry;/presence of cardiac disease that, in opinion of Investigator, increases risk of ventricular arrhythmia or dysfunction; ejection fraction\<50 percent prior to study initiation * History of arrhythmia-symptomatic/requires treatment/asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded * Previous history of corrected QT interval (QTc) prolongation as result from other medication that required discontinuation of that medication * Congenital long QT syndrome/1st degree relative with unexplained sudden death under 40 years * Presence of left bundle branch block * QTc with Bazett's correction that is unmeasurable/\>480 msec on screening ECG. If pt has QTc \>480 msec on screening ECG, screen ECG may be repeated twice. Average QTc from 3 screening ECGs must be \<480 msec in order for pt to be eligible for study * Any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes/induce cytochrome P450 3A4 (CYP3A4) function except for EIAEDs * Hypertension not controlled by medical therapy * Currently active diarrhea that may affect ability of pt to absorb study regimen/tolerate diarrhea * Pregnant/breast feeding * Previous/current malignancies of other histologies \<1yr, w exception of cervical carcinoma in situ \& adequately treated basal cell/squamous cell carcinoma of skin * Receipt of any investigational agents within 30 days prior to commencing study treatment unless pt has recovered from all anticipated toxicities of investigational agent * Last dose of prior chemo discontinued \<4 wks before start of study therapy unless pt has recovered from all anticipated toxicities of chemo * Last radiation therapy (XRT) \<4wks before start of study therapy, unless pt has recovered from all anticipated toxicities of XRT * Any unresolved toxicity \> Common Terminology Criteria (CTC) grade 1 from previous anti-cancer therapy * Previous enrollment/randomization of treatment in present study * Major surgery \<4 wks/incompletely healed surgical incision before starting study therapy * Pts who have received prior oral VEGFR, EGFR/PDGFR-directed therapies * Pts who are taking warfarin sodium
References
Publications (0)
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