Antitumor-B KAC PK Study (NCT05452408) | Clinical Trial Compass
WithdrawnPhase 1
Antitumor-B KAC PK Study
Stopped: Study abandoned.
United States0Started 2026-12
Plain-language summary
Study Design: A Window of Opportunity Clinical Trial. This study design permits examination of effects of an oral agent on cancer patients during the "window" between diagnosis of their cancer and their definitive cancer surgery. Similar to a phase 0 study, the trial design permits examination of the biologic effects of an agent; in this study pharmacokinetic properties will be examined.
Who can participate
Age range18 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
✓. Clinical diagnosis of oral cavity squamous cell cancer.
✓. Patient can start study agent administration but histological confirmation of squamous cell cancer (SCC) of the oral cavity (or histologic variants of SCC) by the pathologist must happen within seven days of registration in order to continue study agent administration.
✓. Clinical stage II-IVA (as defined by the AJCC, 8th Edition) and amenable to surgical resection.
✓. New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a minimum remission of six months following previous definite surgery.
✓. History and physical examination by an otolaryngologist and medical oncologist within 30 calendar days of study registration.
✓. Study agent administration should start within seven days of registration.
✓. Patient must receive administration of study agent for a minimum of seven days.
✓. ECOG Performance status \< 2.
Exclusion criteria
✕. History of active liver disease.
✕. Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
✕. Concurrent use of any medicinal botanical, natural, or other herbal compound/s that the study PI believes could potentially have an impact on the results/objectives of this study.
What they're measuring
1
Area under the Curve (AUC) for Saliva
Timeframe: predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on Day 1
2
Area under the Curve for Plasma
Timeframe: predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on Day 1
. Planned subtotal or debulking surgery, as determined by enrolling physician determination, is not permissible.
✕. Prior systemic chemotherapy for oral SCC; note that prior chemotherapy for a different cancer is allowable.
✕. Prior radiotherapy for oral SCC is permissible if disease free for one year since prior oral cancer treatment and free of significant late radiation effects.
✕. Severe active comorbidity, such as uncontrolled cardiac disease, infection, severe COPD.