The purpose of this research is to test the safety of the study drug (OK-1) and see what effects (good and bad) this drug has on patients with recurrent solid tumors.
OK-1 capsules will be given twice a day, every day in 21-day blocks of time. Each block of time is called a cycle. The cycle will be repeated until the patient or doctor no longer feel participation in the study is right for the patient. There will be lab tests and examinations to monitor the patients progress. We expect that taking part in this research will last up to three years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
OK-1 orally in the form of 50 mg capsules. Four dose levels will be evaluated: 5.4mg/kg 7.0mg/kg 9.0mg/kg 12mg/kg
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Number of dose-limiting toxicities of treatment with OK-1
Time frame: 21 days
Dosage Recommendation for Phase 2
Time frame: 21 days
Rate of objective response
Time frame: up to three years
Median duration of response
Time frame: up to three years
Rate of disease control
Time frame: up to three years
Median progression free survival
Time frame: up to three years
Median overall survival
Time frame: up to three years
Incidence of adverse events
safety and tolerability of OK-1 using Common Terminology Criteria for Adverse Events (CTCAE) v.5.0
Time frame: up to three years
Tmax of PK plasma concentration
Time frame: 24 hours
Cmax of PK plasma concentration
Time frame: 24 hours
AUC of PK plasma concentration
Time frame: 24 hours
t1/2 of PK plasma concentration
Time frame: 24 hours
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