Phase 2
Completed N=95
Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
leukemia · Childhood Myelodysplastic Syndromes · Chronic myelomonocytic leukemia · de Novo Myelodysplastic Syndromes
Source: ClinicalTrials.gov NCT00096122 ↗
Enrolled (actual)
95
Serious AEs
48.4%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With Complete Response — 61; 9 Participants
Summary
This phase I/II trial is studying the side effects and best dose of tipifarnib when given with idarubicin and cytarabine and to see how well it works in treating patients with newly diagnosed myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Tipifarnib (Zarnestra) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving idarubicin and cytarabine with tipifarnib may kill more cancer cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Response |
61; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of 1) AML (WHO classification definition of > 20% blasts), or 2) high risk MDS (defined as the presence of > 10% blasts)
- Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML or MDS; they could have received transfusions, hematopoietic growth factors or vitamins; temporary measures such as pheresis or hydrea (0.5 to 5g daily for up to 3 days) are allowed
- ECOG PS of 0-1 at screening
- Creatinine =< 2 mg/dl
- Total bilirubin =< 2 mg/dL, unless increase is due to hemolysis
- Transaminases (SGPT) =< 2.5 x ULN
- Ability to take oral medication
- Ability to understand and provide signed informed consent
Exclusion Criteria
- Subjects with APL
- Presence of active systemic infection
- Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study
- Known allergy to imidazole drugs (such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, tioconazole, terconazole)
Data sourced from ClinicalTrials.gov (NCT00096122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.