Clinical Trial DRUG KCP-330-008
- A Randomized, Open Label, Phase 2 Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) Versus Specified Physician’s Choice in Patients = 60 Years Old with Relapsed/Refractory Acute Myeloid Leukemia (AML) Who are Ineligible for Intensive Chemotherapy and/or Transplantation
- Principal Investigator
- Olga Frankfurt
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG KCP-330-008
- The purpose of this study is to evaluate the effects of KPT-330 in treatment of relapsed/refractory acute myleloid leukemia(AML).
- Relapsed/refractory AML can have limited treatment options. The medical and scientific communities are always looking at promising treatments. The study drug, KPT-330, is an investigational drug. It has not been approved by the U.S. Food & Drug Administration. KPT-330 works by trapping certain proteins in the cell and cause the cancer cells to die or stop growing. KPT-330 has been tested to establish a safe dose. This study will look at what effects, good and/or bad, has on AML and the participants by comparing it to treatment by current standard drugs.
Some of the eligibility criteria include:
- Participants must be at least 60 years of age or older.
- Participants must have relapsed(cancer came back)/refractory(cancer does not respond to treatment)acute myeloid leukemia (AML).
- Participants have not undergone and are not eligible for stem cell transplantation.
- Description of Treatment
- This is a randomized (like the flip of a coin) study. Participants will be assigned to one of two groups, 2/3 of participants will be put into group 1. Group 1 will take KPT-330 orally (by mouth) twice a week. Group 2 will receive one of 3 current standard treatments for AML. The study doctor will decide which one a participant in group 2 will receive. Participants will remain on the study until their disease worsens or the study doctor feels it is in their best interest to stop.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839 in Patients with Relapsed and/or Treatment-Refractory Leukemia
- A Phase 1b Study of ABT-199 (GDC-0199) in Combination with Azacitidine or Decitabine in Treatment Naïve Subjects with Acute Myelogenous Leukemia Who Are >/= 65 Years of Age and Who Are Not Eligible for Standard Induction Therapy
last updated: 01-Dec-15 05:41 PM
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