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Palbociclib + Cetuximab for Head and Neck Cancer
Study Summary
This trial is testing if a combination of drugs improves overall survival for patients with head and neck squamous cell carcinoma who progressed after treatment with a PD-1/L1 inhibitor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT03007979Trial Design
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- My cancer has worsened despite treatment with a PD-1/L1 inhibitor.I do not have any unmanaged ongoing illnesses.I am 18 years old or older.I have had 3 or fewer treatments for my head and neck cancer.My cancer has a specific genetic change known as Rb loss.I have been treated with a CDK4/6 inhibitor for my head and neck cancer.I have had up to three treatments for my head and neck cancer.My bone marrow and organs are functioning normally.My throat cancer is not related to HPV and has been confirmed by a lab test.I have had another type of cancer in the past year.I have been treated with cetuximab for cancer that came back or spread.I am fully active and can carry on all my pre-disease activities without restriction.My cancer has a specific genetic change called CDKN2A loss-of-function.My cancer has worsened despite treatment with a PD-1/L1 inhibitor.I am 18 years old or older.My brain metastases have been treated and are not getting worse.My cancer has a specific genetic change called CDKN2A loss-of-function.My cancer is a specific type of throat cancer not related to HPV.My cancer can be measured by scans or physical exam.
- Group 1: Arm 1: Palbociclib + Cetuximab
- Group 2: Arm 2: Cetuximab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
What has been the most dangerous side effect linked to Palbociclib?
"This particular clinical trial for Palbociclib is Phase 3, meaning that there is already some data supporting its efficacy and multiple rounds of data supporting safety. Our team at Power rates it as a 3 on our safety scale."
What other research studies have included Palbociclib in their testing?
"As of now, there are a total of 268 clinical trials underway for Palbociclib. Out of these ongoing studies, 46 are in Phase 3. The majority of the research being conducted is based out of Dresden and Arizona; however, 12294 other locations across the globe are also running similar trials."
How many people are being given the opportunity to participate in this medical study?
"The clinical trial is currently enrolling 81 patients between 1 locations, according to the latest information on clinicaltrials.gov."
How is Palbociclib typically employed in medical treatment?
"Palbociclib can help patients with hnscc, squamous cell carcinoma, and other conditions that have been determined by an FDA-approved test. Additionally, it is sometimes used in conjunction with radiation therapy."
Are people still being recruited for participation in this research project?
"Yes, this study is still recruiting patients according to the latest update on clinicaltrials.gov. The original posting was on April 6th, 2022 and there have been no changes since then."
Has this sort of research been conducted before?
"As of today, there are 268 ongoing studies for Palbociclib in 61 countries and 1810 cities. The first clinical trial was sponsored by Bristol-Myers Squibb in 2005 and completed Phase 2 drug approval with the support of 154 participants. In the 15 years since then, 443 trials have been conducted."
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