Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
|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: NCT04149691|
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Bladder Cancer Squamous Non-small Cell Lung Cancer Cholangiocarcinoma Sarcoma Endometrial Cancer||Drug: CPL304110||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies|
|Actual Study Start Date :||July 19, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
CPL304110 will be administered once daily to adults with advanced solid malignancies in 28-day cycles.
CPL304110 is to be administered orally as hard gelatine capsules once daily in 28-day cycles.
Other Name: PG19
- Maximum tolerated dose (MTD) [ Time Frame: First cycle of 28 days ]Maximum tolerated dose (MTD) of CPL304110 when administered orally once daily to adults with advanced solid malignancies. The MTD is the highest dose associated with the occurrence of dose-limiting toxicities (DLTs) in <33% of patients.
- Safety profile [ Time Frame: First cycle of 28 days ]Overall safety profile of CPL304110, as assessed by the type, frequency, severity, timing, and relationship to study drug of any adverse events (AEs), serious adverse events (SAEs), and changes in vital signs, ECGs, and safety laboratory test.
- Recommended Phase 2 Dose (RP2D) determined on the base of the MTD. [ Time Frame: Approximately up to 12 months ]The RP2D will be determined after review and discussion of the pharmacokinetics (PK) profile, type and severity of drug related toxicity and clinical suitability for long-term administration.
- ORR, objective rate response [ Time Frame: Approximately up to 12 months ]ORR, objective rate response defined as the rate of confirmed complete response (CR) or partial response (PR) by RECIST 1.1.
- Maximum plasma concentration (Cmax) [ Time Frame: up to 24 hours after CPL304110 administration ]Cmax defines the maximum concentration of the product in plasma during observation period.
- Time to maximum plasma concentration (tmax) [ Time Frame: up to 24 hours after CPL304110 administration ]tmax defines Time to reach maximum plasma concentration
- Area under the plasma concentration versus time curve (AUC) from 0 up to the time of last quantifiable concentration (AUC0-t) [ Time Frame: up to the time of last quantifiable concentration after CPL304110 administration ]AUC(0-t) defines the area under the curve of plasma concentration vs time, from time point zero up to the time of last quantifiable concentration
- Area under the plasma concentration versus time curve AUC from 0 to infinity (AUC0-inf) [ Time Frame: up to 24 hours after CPL304110 administration ]AUC0-inf defines the area under the curve of plasma concentration vs time, from time point zero extrapolated to infinity
- Terminal half-life (t½) [ Time Frame: up to 24 hours after CPL304110 administration ]Plasma elimination half-life
- Kel: Terminal elimination rate constant [ Time Frame: up to 24 hours after CPL304110 administration ]Terminal elimination rate constant
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): NCT04149691
|Contact: CROS CRO||+48 791 690 firstname.lastname@example.org|
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