Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Soli… (NCT04149691) | Clinical Trial Compass
UnknownPhase 1
Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
Poland42 participantsStarted 2019-07-19
Plain-language summary
The purpose of the study is to determine to evaluate safety and tolerability of CPL304110 when administered once daily to adults with advanced solid malignancies.
Who can participate
Age range25 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent to participate in the study must be performed before any procedure's protocol related
* age of ≥25 years old
* Performance Score ≥70 in accordance with the Karnofsky Performance Score (KPS),
* life expectancy period of at least 3 months on the screening day,
* Have measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
* subject (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception
* adequate blood, liver, renal and urine parameters
* phosphate levels within normal range
* HIV, HCV (hepatitis C virus) and HBV negative (hepatitis B virus),
* adequate cardiac function
Inclusion Criteria Specific for parts:
Part 1
* Patients with histologically confirmed advanced gastric cancer, bladder cancer, squamous lung cancer or non-small cell lung cancer with squamous immunophenotype, cholangiocarcinoma, sarcoma or endometrial cancer, be refractory to prior therapies and without effective further treatment options.
Part 2 and 3
* Patients with histologically confirmed advanced gastric cancer, bladder cancer, squamous lung cancer or non-small cell lung cancer with squamous immunophenotype, be refractory to prior therapies and without effective further treatment options.
* Subject's archival formalin-fixed paraffin-embedded (FFPE) tumour sample available for molecular alter…