STAT Inhibitor OPB-111077, Decitabine and Venetoclax in Treating Patients With Acute Myeloid Leukemia That Is Refractory or Newly Diagnosed and Ineligible for Intensive Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03063944|
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia||Drug: STAT Inhibitor OPB-111077 Drug: Decitabine Drug: Venetoclax||Phase 1|
I. To determine the safety and tolerability of STAT inhibitor OPB-111077 (OPB-111077) in combination with decitabine and venetoclax.
I. To describe any preliminary efficacy of OPB-111077 in combination with decitabine and venetoclax in patients with acute myeloid leukemia (AML).
II. To measure adenosine triphosphate (ATP) generation and perform metabolomics in patients with AML who are receiving OPB-111077 and decitabine and venetoclax.
III. To assess apoptosis and proliferation assays in patients with AML who are receiving OPB-111077, decitabine and venetoclax.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of OPB-111077 in Combination With Decitabine and Venetoclax for the Treatment of AML Refractory to or Ineligible for Intensive Chemotherapy|
|Actual Study Start Date :||March 17, 2017|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
Experimental: Treatment (STAT inhibitor OPB-111077, decitabine)
Patients receive STAT inhibitor OPB-111077 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive decitabine IV on days 8-12. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Drug: STAT Inhibitor OPB-111077
Other Name: OPB-111077
- Incidence of grade 4, non-hematologic dose limiting toxicities assessed by National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ]Data analysis will be descriptive. All estimates of dose-specific rates (e.g., response and toxicity) will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used for any rate related to definition of dose limiting toxicity, due to two-stage sampling. The method of Conover will be used otherwise.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063944
|Contact: Margaret Kasner, MDemail@example.com|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19171|
|Contact: Margaret Kasner, MD 215-955-5769|
|Principal Investigator:||Margaret Kasner, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|