Clinical trial · Interventional
Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia
Phase I Study of Zarnestra (R115777.USA30) and Gleevec (Imatinib Mesylate) in Chronic Phase Chronic Myelogenous Leukemia (CML)
NCT00040105CI-TRIAL-00007693completedPhase 1ClinicalTrials.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 goal of this clinical research study is to find the highest safe dose of the drugs ZarnestraTM (R115777) and Gleevec (imatinib mesylate) that can be given in combination for the treatment of chronic myelogenous leukemia (CML) in chronic phase. The effect of this combination on the leukemia will also be studied.
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 |
|---|---|---|---|
| Leukemia, Myeloid, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gleevec (Imatinib mesylate) | Drug | — | UNRESOLVED |
| Zarnestra (R115777) | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zarnestra + Gleevec
- interventionNames
- Drug: Zarnestra (R115777)
- Drug: Gleevec (Imatinib mesylate)
Primary outcomes (1)
- measure
- Maximum tolerated doses (MTD)
- timeFrame
- Every 3 months
Secondary outcomes (1)
- measure
- Toxicity of the ZARNESTRA and Gleevec combination
- timeFrame
- July 2009
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 16 years or older with Philadelphia chromosome (Ph)- or BCR/ABL-positive CML (as determined by cytogenetics, FISH, or PCR) are eligible if they are not candidates for known regimens or protocol treatments of higher efficacy or priority. Patients must be in the chronic phase of CML. * Patients must have failed therapy with imatinib mesylate. Failure will be defined as: 1) patients who have failed to achieve or have lost a complete hematologic remission at 3 months from the start of therapy with imatinib mesylate, or 2) patients who have failed to achieve or have lost at least a minimal cytogenetic response after 6 months of therapy with imatinib mesylate, or 3) patients who have failed to achieve or have lost a major cytogenetic response after 12 months of therapy with imatinib mesylate * Chronic phase will be defined by the following features: 1) blasts in peripheral blood or bone marrow \<10%, 2) basophils in PB or BM \<20%, 3) platelets \>100 x 10(9)/L, 4) absence of clonal evolution * Patients must sign an informed consent * Performance status \</= 2 by Zubrod scale * Patients must have adequate hepatic functions (bilirubin \</= 2.0 mg/dl) and renal functions (creatinine \</=2 mg/dl) * WBC \</= 30 x 10(9)/L. Patients may receive Hydroxyurea (or other similar agent) to bring the WBC below this level. Hydroxyurea (or its equivalent) must be discontinued 24 hours before the start of therapy. * Patients of childbearing potential should practice effective methods of contraception. Exclusion Criteria: * Patients under 16 years of age. * Pregnant and nursing females will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.