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: Accepting New Patients
- 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
Find Related Clinical Trials
Browse by Disease Sites
Other Clinical Trials by Jessica Altman
- A Phase I, Multi-Center, Single Arm, Open-Label Study of Mocetinostat (MGCD0103) in Combination with Azacitidine in Subjects with Intermediate or High Risk Myelodysplastic Syndrome (MDS)
- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation
- 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 IIa, Multicenter, Open-Label Study Designed to Evaluate the Safety and Efficacy of Escalating Doses of BL-8040 in Adult Subjects with Relapsed/Refractory Acute Myeloid Leukemia
- Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE
- A Phase 1 Study of CSL362 (Anti-IL3Ra / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse
- A Randomized Phase II Study of Oral Sapacitabine in Elderly Patients with Acute Myeloid Leukemia Previously Untreated or in First Relapse
- A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia
- A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Relapsed/Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic Malignancies
- Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age = 60 Years)
- A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients with Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
- 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: 17-Dec-14 06:43 PM
Clinical trial availability changes frequently. Please check this site often for updates or call 312.695.1102 for personal assistance.