Spots Global Cancer Trial Database for Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid Leukemia
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Trial Identification
Brief Title: Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid Leukemia
Official Title: A Phase 2 Study of Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other Myelodysplastic /Myeloproliferative Neoplasias, and Acute Myeloid Leukemia
Study ID: NCT02807272
Conditions
Interventions
Study Description
Brief Summary: A Phase 2 study to investigate the antitumor activity in terms of overall response rate (ORR) of tipifarnib in approximately 36 eligible subjects with Myelodysplastic/Myeloproliferative Neoplasias (MDS/MPN), including Chronic Myelomonocytic Leukemia (CMML), and 36 eligible subjects with Acute Myeloid Leukemia (AML). Subjects (amendment 3 Cohorts 1-4) will receive tipifarnib administered at a dose of 400 mg, orally with food, twice a day (bid) for 21 days in 28 day cycles.
Detailed Description: This Phase 2 study will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with Myelodysplastic/Myeloproliferative Neoplasias (MDS/MPN cohorts) and Acute Myeloid Leukemia (AML cohorts). For MDS/MPN cohorts, this study will assess the antitumor activity of tipifarnib, in terms of ORR, in subjects with MDS/MPN, including CMML, who have a high ratio of expression of CXCR4 to CXCR2 (CXCR4/2 ratio) in their bone marrow and in those with a low CXCR4/2 ratio. For AML cohorts, this study will assess the antitumor activity of tipifarnib, in terms of ORR, in subjects with AML who have a high ratio of expression of CXCR4 to CXCR2 (CXCR4/2 ratio) in their bone marrow and in those with low CXCR4/2 ratio. Subjects enrolled in the study will consist of patients with KRAS, NRAS wild type status. 1. Subjects with MDS/MPN with high CXCR4/2 ratio 2. Subjects with MDS/MPN with low CXCR4/2 ratio 3. Subjects with AML with high CXCR4/2 ratio 4. Subjects with AML with low CXCR4/2 ratio
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Scottsdale, Arizona, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc., Tampa, Florida, United States
Johns Hopkins University, Baltimore, Maryland, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Weill Cornell Medicine, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Contact Details
Name: TBD TBD, TBD
Affiliation:
Role: PRINCIPAL_INVESTIGATOR
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