Phase 1 Trial of OK-1 (SHetA2) in Patients With Advanced or Recurrent Solid Tumors
University of Oklahoma
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologic diagnosis of recurrent solid tumor which has progressed through available therapies with expected survival benefit. Histologic documentation of the original primary tumor is required via the pathology report. Patients must have adequate: * Bone marrow function as defined per protocol * Renal function as defined per protocol * Hepatic function as defined per protocol * International normalized ratio (INR) or prothrombin time (PT) ≤1.5x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) i…
Interventions
- DrugOK-1
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
Location
- Stephenson Cancer CenterOklahoma City, Oklahoma