Clinical Trial DRUG B1371003
- A Phase 1B Study to Evaluate the Safety and Preliminary Efficacy of Pf-04449913, an Oral Hedgehog Inhibitor, in Combination with Intensive Chemotherapy, Low Dose ARA-C or Decitabine in Patients with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
- Principal Investigator
- Jessica Altman
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG B1371003
- The purpose of this study is to learn about the effects of the study drug, PF-04449913, in combination with chemotherapy, and to find the best dose of PF-04449913 for treating Acute Myeloid Leukemia (AML)and high-risk Myelodyplastic Syndrome(MDS).
- This study is for patients with untreated AML or high-risk MDS. PF-04449913 is an investigational drug. An investigational drug is one that is currently not approved by the Food and Drug Administration (FDA) for sale in this country. PF-04449913 is in a class of drugs known as hedgehog inhibitors and is designed to stop the growth of certain cancer stem cells which may be allowing the cancer to grow.
Some of the eligibility criteria include:
- Study participants must have a diagnosis of AML or high-risk MDS. Participants may have had one prior treatment for MDS and no prior treatment for AML.
- Participants must be 18 or older. Participants older than 75 may only be enrolled in arms A or B.
- Description of Treatment
- Participants will be assigned to one of three arms, dependent on whether or not they can tolerate intensive chemotherapy. Participants who cannot tolerate intensive chemotherapy will either be in Arm A or B. Participants who can tolerate intensive chemotherapy and their doctor feels this is the best treatment option will be in Arm C. Participants in Arm A will receive PF-0444913 in combination with low dose Ara-C (LDAC). LDAC is approved for the treatment of AML and MDS. Arm B participants will receive PF-04449913 in combination with Decitabine (Dacogen). Decitabine is approved for the treatment of high-risk MDS but it is not approved for the treatment of AML. Arm C participants will receive PF-04449913 in combination with intensive chemotherapy (Ara-C and Daunorubicin).
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects with Advanced Hematologic Malignancies with an IDH2 Mutation
- 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 II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
last updated: 04-May-16 06:09 PM
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