Clinical Trial DRUG CYC682-12
- A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia
- Principal Investigator
- Jessica Altman
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CYC682-12
- This study has two parts. The purpose of the first part of this study is to confirm the safety and tolerability of giving sapacitabine in alternating cycles with decitabine. The purpose of the second part of this study is to learn that among several drug options, which one is more likely to keep your cancer in check as long as possible.
- This Phase III study assesses an experimental anti-cancer drug called sapacitabine and a marketed anti-cancer drug called decitabine. An experimental drug means it has not been approved by the U.S. Food and Drug Administration (FDA) or other regulatory agencies for marketing and is still under study to determine whether or not it is effective in the treatment of cancer. Decitabine has been approved the FDA for the treatment of a bone marrow disease called myelodysplastic syndromes (MDS), but has not been approved for the treatment of acute myeloid leukemia (AML).
Some of the eligibility criteria include:
- Participants must be 70 years of age or older.
- Participants must be diagnosed with acute myeloid leukemia (AML).
- Participants may not have been previously treated with systemic therapy (for example, chemotherapy).
- Description of Treatment
- Participants will join either the first part of the study or the second part of the study. Study drug will be given per cycle. One cycle is 28 days. If participating in the first part of the study, participants will receive decitabine for the first cycle, sapacitabine for the second cycle, decitabine again for the third cycle, sapacitabine again for the fourth cycle, so on and so forth. For all odd-numbered cycles, participants will receive decitabine by vein. For all even-numbered cycles, participants will take sapacitabine capsules by mouth two times a day. If participating in the second part of this study, participants will be randomly assigned by a computer to take one of the study drug options, in the same way as the cycles described above. Neither participant nor study doctor can choose the assignment.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients with Advanced Hematologic Malignancies with an IDH1 and/or IDH2 Mutation
- A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
- A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
last updated: 06-Oct-15 09:29 PM
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