Clinical trial · Interventional
Glivec Phase II Pediatric Study
Open Label, Pilot Phase II Study of Glivec in Children and Adolescents With Life Threatening Diseases Known to Be Associated With One or More Glivec-Sensitive Tyrosine Kinases
NCT00180830CI-TRIAL-00000438terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether Glivec is effective, in children, adolescents and young adults, in the treatment of malignant disease in which evidence suggests a potential pathogenic role of one or more of the tyrosine kinases known to be inhibited by Glivec.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gleevec | Drug | — | UNRESOLVED |
| Glivec | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- - Tumour Response
Secondary outcomes (1)
- measure
- Progression-free Survival, overall Survival, safety and tolerability, pharmacokinetic profile and pharmacodynamics of Glivec, pharmacogenetics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients from 6 months to 21 years of age. * Malignant disease documented by conventional criteria to be refractory to standard, approved therapy, or for which no conventional therapies of definitive benefit exist. * Immunohistochemistry documentation of positivity of either Kit (CD117) or PDGF-R in tumor tissue relevant. Each positive tumor will be centrally reviewed before inclusion of the patient in the trial. * Measurable or evaluable disease. * WHO Performance status 0,1, or 2 or Lansky Play Scale \>= 50%. * Adequate organ function, defined as the following: total bilirubin \< 1.5 x ULN, SGOT and SGPT \< 2.5 x UNL (or \< 5 x ULN if hepatic disease involvement is present), creatinine \< 1.5 x ULN, ANC \> 1x 109/L, platelets \> 75 x 109/L. * Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. * Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. * Life expectancy of more than 6 weeks. * Written, voluntary, informed consent, including consent for retrieval and investigational use of tissue samples for evaluation signed by parents or young adult patients. * National and, when needed, local ethical approval. Exclusion Criteria: * Patient with hematological disease positive for the chimeric BCR-ABL fusion protein or for c-kit. * Patient has received any other investigational agents within 28 days of first day of study drug dosing. * Female patients who are pregnant or breast-feeding. * Patient has another severe and/or life-threatening medical diseasePatient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis). * Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. * Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by the study coordinator.
References
Publications (0)
Data not yet available
No reference posted for this study.