MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class (MASTIFF)
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|ClinicalTrials.gov Identifier: NCT03036228|
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : February 21, 2019
The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of cancer.
Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Karonudib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Dose escalation
Karonudib is an oral inhibitor of MTH1 and will be supplied as an oral solution to be taken every other day. There are eight planned dose cohorts. Patients will be given every second day dosing from week 1 (after evaluation of PK data and safety).
Dose escalation of administration with oral solution of Karonudib.
- Safety and tolerability of Karonudib (TH1579) will be evaluated. [ Time Frame: 28 days, first treatment cycle for the patient. ]
Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD). DLTs will be assessed during first cycle of therapy, week 1-4 based on Haematological toxicity and Non-haematological toxicity.
MTD: The highest dose of Karonudib that does not cause unacceptable side effects is defined as the MTD.
- To determine the pharmacokinetics of Karonudib. [ Time Frame: 28 days, first treatment cycle for the patient ]Peak Plasma Concentration, Cmax
- To determine the pharmacokinetics of Karonudib. [ Time Frame: 28 days, first treatment cycle for the patient ]Tmax, time is the time to reach Cmax (Peak Plasma Concentration)
- To determine the pharmacokinetics of Karonudib. [ Time Frame: 28 days, first treatment cycle for the patient ]biological half-life (plasma T1/2)
- To determine the pharmacokinetics of Karonudib. [ Time Frame: 28 days, first treatment cycle for the patient ]Area under the Curve (AUC)
- To determine preliminary signs of clinical efficacy of Karonudib. [ Time Frame: 54 days, two treatment cycles for the patient ]RECIST 1.1
- To determine overall survival. [ Time Frame: Up to 12 months. ]SAE
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): NCT03036228
|Contact: Teresa Sandvall, MScfirstname.lastname@example.org|
|Karolinska University Hospital||Recruiting|
|Contact: Jeffrey Yachnin, MD, PhD|
|Principal Investigator: Jeffrey Yachnin, MD, PhD|
|Study Director:||Teresa Sandvall, MSc||Oxcia|