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Monoclonal Antibodies
PD 0332991 + Cetuximab for Squamous Cell Carcinoma
Phase 1 & 2
Waitlist Available
Led By Douglas Adkins, M.D.
Research Sponsored by Washington University School of Medicine
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 up to 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see what dose is safe and what side effects it causes when combined with another cancer drug.
Who is the study for?
This trial is for adults with incurable squamous cell carcinoma of the head and neck (SCCHN), who have tried at least one treatment cycle without success. Participants must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and cannot have certain health conditions like uncontrolled heart disease or active infections.Check my eligibility
What is being tested?
The study is testing the combination of a drug called PD 0332991 with cetuximab to find the highest dose patients can tolerate without severe side effects. It's in Phase I/II which means they're looking at safety and how well it works on different groups based on prior treatments and HPV-related cancer status.See study design
What are the potential side effects?
Possible side effects include allergic reactions similar to those from compounds related to PD 0332991 or cetuximab, as well as general risks associated with cancer drugs such as fatigue, digestive issues, skin reactions, blood disorders, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I - Maximum Tolerated Dose (MTD)
Phase II: Efficacy as Measured by Overall Response Rate
Secondary outcome measures
Phase I: Most Frequent Adverse Events
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Phase II: Cetuximab Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
+4 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Phase II Arm 3:Experimental Treatment2 Interventions
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Group II: Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHNExperimental Treatment2 Interventions
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Group III: Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHNExperimental Treatment2 Interventions
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Group IV: Phase I: Dose Level 2Experimental Treatment2 Interventions
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Group V: Phase I: Dose Level 1Experimental Treatment2 Interventions
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
PD 0332991
2008
Completed Phase 2
~360
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Who is running the clinical trial?
PfizerIndustry Sponsor
4,582 Previous Clinical Trials
14,634,701 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,729 Total Patients Enrolled
Douglas Adkins, M.D.Principal InvestigatorWashington University School of Medicine
11 Previous Clinical Trials
467 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received treatment with cetuximab in the past for your condition.You are currently taking medications called proton pump inhibitors.You have had allergic reactions to similar drugs like PD 0332991 or cetuximab in the past.You are not currently taking any experimental drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
- Group 2: Phase I: Dose Level 2
- Group 3: Phase I: Dose Level 1
- Group 4: Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
- Group 5: Phase II Arm 3:
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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