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Oral Cancer Drug for Squamous Cell Carcinoma

MC
Overseen ByMedical College of Wisconsin Cancer Center Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Stuart J. Wong, MD | Froedtert & the ...

Stuart J. Wong, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Adults diagnosed with oral cavity squamous cell cancer, fit for surgery (stage II-IVA), and have good organ function. They must not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and can't have had certain prior treatments for oral SCC. No severe comorbidities like uncontrolled heart disease or severe COPD.

Inclusion Criteria

Study agent administration should start within seven days of registration
I am following the required birth control measures.
Patients must be deemed able to comply with the study plan
See 13 more

Exclusion Criteria

Pregnant or lactating women
I have a history of active liver disease.
I am currently taking prescribed medications.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the natural botanical compound ATB-KAC and provide blood and saliva samples during administration

1-4 weeks
Multiple visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Antitumor B KAC
Trial Overview The trial is testing Antitumor B KAC's effects on patients with squamous cell carcinoma during the short period between their diagnosis and surgery. It focuses on how the body processes the drug (pharmacokinetics).
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Antitumor B KACExperimental Treatment1 Intervention
ATB will be administered on an outpatient basis.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+
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