Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS
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|ClinicalTrials.gov Identifier: NCT03187288|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : April 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndromes Relapsed Cancer Refractory Cancer||Drug: CFI-400945 Fumarate||Phase 1|
Participants will be screened prior to the start of the study drug for eligibility.
Eligible participants will take CFI-400945 by mouth, once a day, every day of each 28 day cycle. Participants will be asked to keep a study drug diary.
While receiving the study drug, participants will have standard tests and procedures done for safety purposes.
Procedures for research purposes include bone marrow aspirate and additional blood collection for biomarker research, and additional blood samples for pharmacokinetic research.
When participants stop the study drug permanently for any reason, they will be asked to have an End of Treatment Visit and be followed for safety purposes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Dose Escalation, Safety and Pharmacokinetic Study of CFI-400945 Fumarate Administered Orally to Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome|
|Actual Study Start Date :||May 25, 2018|
|Estimated Primary Completion Date :||April 2, 2021|
|Estimated Study Completion Date :||April 4, 2022|
CFI-400945 will be given by mouth at 64,96,128,160,192 or 224 mg/day, everyday until intolerable side effects or disease progression.
Drug: CFI-400945 Fumarate
CFI-400945 is an investigational drug that is being look at for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CFI-400945 is an oral (taken by mouth) drug that blocks Polo-like kinase 4 (PLK4) activity. PLK4 is a protein that is important in regulating cell growth and division and cell death. Many tumors are shown to make too much PLK4. When there is too much PLK4 produced, it is believed to contribute to uncontrolled cancer cell growth and division. Therefore, by blocking this protein from working, it is believed to stop tumors from growing or shrink them.
- Evaluation of the frequency and severity of treatment-emergent adverse events in patients [ Time Frame: 5 years ]This will be done to assess safety and tolerability of CFI-400945 fumarate
- Highest tolerated dose of CFI-400945 fumarate [ Time Frame: 5 years ]The Maximum Tolerated Dose MTD is defined as the highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing cohort.
- Recommended phase 2 dose of CFI-400945 fumarate [ Time Frame: 5 years ]Following completion of dosing of at least 1 cycle for all patients enrolled the Recommended Phase 2 Dose (RP2D) will be determined.It will be based upon the MTD established during dose escalation and its comprehensive outcome
- Number of participants with response to treatment [ Time Frame: 5 years ]Patients responses will be assess using the International Working Group response criteria for AML and MDS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187288
|Contact: Karen Yee, M.D.||firstname.lastname@example.org|
|Juravinski Hospital and Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada, L8V 1C3|
|Contact: Brian Leber, M.D. 905-521-2100|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Karen Yee, M.D. 416-946-4495|
|Principal Investigator:||Karen Yee, M.D.||Princess Margaret Cancer Centre|