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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
February 2015
NCT00093470Uploaded 03-19-2024
Access via NCI by Request
PDS UID: nci-data-540
A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure or Patients Over Age 60 in First Remission
Provider Information
Provider Data DescriptionThere are three submissions for PMID 34773794. This dataset, NCT00093470-D1, contains baseline, treatment, and efficacy data. Dataset NCT00093470-D2 contains toxicity data reported on study. Dataset NCT00093470-D3 contains toxicity data reported during the first three cycles of treatment or the first three months post registration.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies tipifarnib in treating patients with acute myeloid leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective than observation alone in preventing the recurrence of AML.
ConditionsAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With Minimal Differentiation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Adult Erythroleukemia
Adult Pure Erythroid Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
Myelodysplastic Syndrome With Excess Blasts
Recurrent Adult Acute Myeloid Leukemia
Intervention TypeProcedure: Clinical Observation
Drug: Tipifarnib
Drug(s)Drug: Tipifarnib
Total Enrolled144
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (tipifarnib) - Experimental
Arm B (clinical observation) - Other
Secondary IDNCI-2009-00535
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Israel
Peru
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00093470-D1
Data DictionaryNCT00093470-D1-Data-Dictionary_1.pdf
DATANCT00093470-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00093470-D2
Data DictionaryNCT00093470-D2-Data-Dictionary_1.pdf
DATANCT00093470-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00093470-D3
Data DictionaryNCT00093470-D3-Data-Dictionary_1.pdf
DATANCT00093470-D3-Dataset.csv
OTHERREADME.pdf
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