Clinical trial · Interventional
Tipifarnib and Bortezomib in Treating Patients With Acute Leukemia or Chronic Myelogenous Leukemia in Blast Phase
A Phase I Dose-Escalation Study of R115777 (Tipifarnib) Plus PS-341 (Bortezomib) in Relapsed or Refractory Acute Leukemias
NCT00383474CI-TRIAL-00017506completedPhase 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)
This phase I trial is studying the side effects and best dose of tipifarnib and bortezomib in treating patients with acute leukemia or chronic myelogenous leukemia in blast phase. Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tipifarnib together with bortezomib may kill more cancer cells.
Conditions
Conditions (21)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Basophilic Leukemia | Adult Acute Basophilic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Eosinophilic Leukemia | — | UNRESOLVED | — |
| Adult Acute Megakaryoblastic Leukemia | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Monoblastic Leukemia | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Monocytic Leukemia | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 | Adult Acute Myeloid Leukemia with inv(16)(p13.1q22); CBFB-MYH11 | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia With Maturation | Adult Acute Myeloid Leukemia with Maturation | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia With Minimal Differentiation |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients will receive an infusion of bortezomib twice a week for 2 weeks. They will also receive tipifarnib by mouth twice a day for 2 weeks.
- interventionNames
- Drug: Bortezomib
- Other: Laboratory Biomarker Analysis
- Drug: Tipifarnib
Primary outcomes (1)
- measure
- Dose-limiting toxicity and maximum tolerated dose of tipifarnib and bortezomib
- timeFrame
- 21 days
Secondary outcomes (4)
- measure
- Changes in apoptotic protein expression (Bim, Bax, AKT)
- timeFrame
- Baseline and day 8
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Meets 1 of the following disease-specific criteria: * Relapsed disease after =\< 2 prior chemotherapy regimens (consolidation therapy excluded) * Primary-induction failure * Previously untreated and deemed unfit for or refusing cytotoxic chemotherapy * No hyperleukocytosis (leukemic blasts \>= 30,000/mm\^3) * No acute promyelocytic leukemia (M3) * No active CNS leukemia * SGOT and SGPT =\< 2 times upper limit of normal (ULN) * Bilirubin normal * Creatinine =\< 1.5 times ULN * No uncontrolled hypertension, congestive heart failure, angina pectoris, or ventricular dysrhythmias * Not pregnant or nursing * Negative pregnancy test * No uncontrolled disseminated intravascular coagulation * Fertile patients must use effective contraception * Hormonal contraception must have been initiated ≥ 1 month prior to study entry * No active graft-vs-host disease * No active uncontrolled infection * No intrinsic impaired organ function * No known allergy to imidazole drugs * No neuropathy \>= grade 1 * No known hypersensitivity to bortezomib, tipifarnib, boron, or mannitol * No physical or psychiatric conditions that would preclude study participation, including poorly controlled psychosis * At least 48 hours since prior hydroxyurea * No prior tipifarnib, bortezomib, or investigational proteasomal inhibitors * No concurrent radiotherapy, chemotherapy, or immunotherapy * No concurrent enzyme-inducing antiepileptic medications (e.g., phenytoin, phenobarbital, or carbamazepine) * ECOG performance status 0-2 * LVEF \>= 40% * Pathologically confirmed diagnosis of 1 of the following: * Acute myeloid leukemia * Acute lymphoblastic leukemia * Chronic myelogenous leukemia in blast phase
References
Publications (0)
Data not yet available
No reference posted for this study.