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Oral Cancer Drug for Squamous Cell Carcinoma
Phase 1
Waitlist Available
Led By Stuart J. Wong, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on day 1
Awards & highlights
Study Summary
This trial looks at the effects of an oral cancer drug on patients between their cancer diagnosis and surgery.
Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Specific side effects are not listed here but generally may include reactions related to the immune system, liver function changes, fatigue, gastrointestinal issues, blood-related problems based on similar pharmacological profiles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on day 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the Curve (AUC) for Saliva
Plasma Exchange
Cmax for Plasma
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Antitumor B KACExperimental Treatment1 Intervention
ATB will be administered on an outpatient basis.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,575 Total Patients Enrolled
Stuart J. Wong, MDPrincipal InvestigatorMedical College of Wisconsin
4 Previous Clinical Trials
171 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am following the required birth control measures.My cancer is at a stage where surgery is possible.I have a history of active liver disease.I am currently taking prescribed medications.I have had chemotherapy for oral cancer before.I had radiotherapy for oral cancer and have been disease-free for a year.I have been diagnosed with squamous cell cancer of the mouth.I have been examined by an ear, nose, and throat doctor and a cancer specialist within the last 30 days.I can do most of my daily activities without help.My kidney and liver are functioning well.I can take medicine through a tube in my stomach.I am scheduled for surgery to remove part of a tumor.I do not have severe heart disease, uncontrolled infections, or severe lung problems.My recent blood test shows my bone marrow is working well.I have a new or returning oral cancer after 6 months of clear health post-surgery.My oral cancer has been confirmed as squamous cell cancer by a pathologist.I am 18 years old or older.I can take the study medication for at least seven days.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Antitumor B KAC
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants being enrolled in this experiment at present?
"This medical research, which was initially published on December 1st 2022 and last updated on July 6th 2022, is not recruiting at this time. Nonetheless, there are 8 other trials currently seeking volunteers."
Answered by AI
To what extent might Antitumor B KAC be harmful to individuals?
"This assessment of Antitumor B KAC's safety was concluded with a score of 1. This is due to the limited clinical data available for this phase one trial, which means there are minimal supporting evidence for its efficacy and safety."
Answered by AI
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