A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02792465|
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Cancers||Drug: CFI-402257||Phase 1|
CFI-402257 is an oral drug that blocks TTK protein kinase (also known as Monopolar spindle 1 [Mps1]) activity. TTK is a protein that is important in regulating cell growth, and cell death, and ensuring proper division. Many tumors are shown to make too much TTK. When there is too much TTK produced, it is believed to contribute to uncontrolled cancer cell growth and division leading to additional mutations in cancer cells. Therefore, it is believed that blocking this protein from working will lead to cancer cell death, stopping tumors from growing or shrinking them.
This study will have two parts: dose escalation and dose expansion.
The dose escalation part will test different dose levels of study drug in groups of patients to find the highest dose of study drug that can be given safely to patients (called maximum tolerated dose or MTD).
The expansion part will further assess the safety, tolerability, and PK of the MTD found in the escalation part of the study in additional group of patients.
|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-402257 Administered Orally to Patients With Advanced Solid Tumors|
|Actual Study Start Date :||November 11, 2016|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
CFI-402257 capsules will be taken orally, once a day, every day.
- Highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing cohort [ Time Frame: 2 years ]
- Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03 [ Time Frame: 2 years ]
- Treatment-emergent changes in vital signs [ Time Frame: 2 years ]
- Treatment-emergent changes in clinical laboratory tests from baseline values obtained prior to treatment [ Time Frame: 2 years ]
- Treatment-emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), at periodic intervals during the study and at End of Treatment [ Time Frame: 2 years ]
- Area under the plasma concentration-time curve (AUC) [ Time Frame: 2 years ]
- Elimination half-life (T½) [ Time Frame: 2 years ]
- Maximum plasma concentration (Cmax) [ Time Frame: 2 years ]
- Minimum plasma concentration (Cmin) [ Time Frame: 2 years ]
- Time when Cmax occurs (Tmax) [ Time Frame: 2 years ]
- Average plasma concentration at steady state (Cavg) [ Time Frame: 2 years ]
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): NCT02792465
|Contact: Philippe Bedard, M.D.||416-946-4534|
|Canada, British Columbia|
|BC Cancer Agency||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Contact: Daniel Renouf, M.D. (604) 877-6000|
|Principal Investigator: Daniel Renouf, M.D.|
|The Ottawa Hospital Cancer Centre||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: John Hilton, M.D. (613) 737-7700|
|Principal Investigator: John Hilton, M.D.|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Philippe Bedard, M.D. (416) 946-4534|
|Principal Investigator: Philippe Bedard, M.D.|
|Principal Investigator:||Philippe Bedard, M.D.||Princess Margaret Cancer Centre|