Dose Escalation and Cohort Expansion Study of TEN-010 in Patients with Acute Myeloid Leukemia and Myelodysplastic SyndromePosted: November 17, 2014 Filed under: Clinical Trials | Tags: Acute Myeloid Leukemia, Blood Disorders, cancer, Gail Roboz, Gail Roboz MD, Leukemia, Myelodysplastic Syndrome Comments Off on Dose Escalation and Cohort Expansion Study of TEN-010 in Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome
The Weill Cornell Leukemia Program has recently opened a new clinical trial for men and women who have been diagnosed with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). The study sponsor is Tensha Therapeutics, Inc. and the principal investigator at Weill Cornell is Dr. Gail Roboz. For more information about the study, please call Tania Curcio, RN at (212) 746-2571 or e-mail firstname.lastname@example.org.
- Men and women age 18 and older with a confirmed diagnosis of AML or MDS
- Previously treated with at least one prior therapy
- Subjects with a history of allogeneic (from another person) stem cell transplant are eligible for study participation
- Life expectancy of at least 2 months
- Detailed eligibility reviewed when you contact the study team
This is a Phase 1, non-randomized, open-label, multi-center study that utilizes the investigational study drug TEN-010. TEN-010 belongs to a group of drugs called bromodomain inhibitors. Bromodomains are found in cancer cells and bromodomain inhibitors may have promise as a therapy for patients who have cancer. Currently, there are no bromodomain inhibitors approved by the FDA for humans. Research in the laboratory has shown that TEN 010 kills cancer cells in different types of both blood cancers.
The study is conducted in two parts; Part A and Part B. In Part A, escalating doses of TEN-010 will be administered to patients to evaluate safety and side effects that may limit the amount of TEN-010 given to patients. One of the goals of Part A is to establish the maximum tolerated dose (MTD) of TEN-010. Part B is an expansion study in which patients are treated at the MTD of TEN-010 to identify safety, tolerability, and how well the disease responds to treatment with TEN-010.
All subjects participating in this study will receive the study drug TEN-010 once daily. Subjects will be assigned to one of three different dose levels ranging from 0.06 mg/kg to 0.24 mg/kg .