Peposertib + Radiation for Advanced Head and Neck Cancer
Trial Summary
Do I need to stop my current medications for the trial?
Yes, you may need to stop certain medications. The trial excludes participants who cannot discontinue proton pump inhibitors 5 days before treatment and those taking strong inhibitors, inducers, or sensitive substrates of specific enzymes (CYP3A4/5, CYP2C19, CYP2C9, CYP1A2, CYP2B6) before the study. Opioids are allowed, except methadone.
Will I have to stop taking my current medications?
The trial requires participants to stop taking proton pump inhibitors 5 days before treatment and any medications that are strong inhibitors, inducers, or sensitive substrates of certain liver enzymes (CYP3A4/5, CYP2C19, CYP2C9) before starting the study. Opioids are allowed, except for methadone.
What data supports the idea that Peposertib + Radiation for Advanced Head and Neck Cancer is an effective treatment?
The available research does not provide specific data on the effectiveness of Peposertib + Radiation for Advanced Head and Neck Cancer. Instead, it discusses other treatments like gefitinib, pembrolizumab, cetuximab, and tepotinib in combination with radiation or chemoradiation for similar conditions. These studies focus on the safety, feasibility, and potential benefits of these treatments, but do not mention Peposertib. Therefore, there is no direct evidence from the provided information to support the effectiveness of Peposertib + Radiation for this condition.12345
What data supports the effectiveness of the drug Peposertib in combination with radiation for advanced head and neck cancer?
The research on similar treatments, like the MET inhibitor tepotinib, shows that targeting specific pathways can enhance the effectiveness of radiation therapy in head and neck cancer by making cancer cells more sensitive to radiation. This suggests that Peposertib, which may work in a similar way, could potentially improve treatment outcomes when combined with radiation.12345
What safety data exists for Peposertib + Radiation in head and neck cancer?
The provided research does not contain specific safety data for Peposertib (also known as M3814, MSC2490484A, nedisertib) combined with radiation for head and neck cancer. The studies focus on other treatments and combinations, such as gefitinib, panitumumab, linifanib, cetuximab, and olaparib, in combination with radiation or chemoradiation for head and neck cancer. Therefore, no relevant safety data for Peposertib + Radiation is available in the provided research.14678
Is the drug Peposertib a promising treatment for advanced head and neck cancer?
What makes the drug Peposertib unique for treating advanced head and neck cancer?
What is the purpose of this trial?
This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.
Research Team
Maura L Gillison
Principal Investigator
NRG Oncology
Eligibility Criteria
This trial is for adults with advanced head and neck cancer who can't take cisplatin. Participants must be HIV-positive on effective treatment, able to swallow tablets, willing to use contraception, have certain types of oropharynx cancer stages, measurable disease per RECIST 1.1 criteria, specific blood cell counts within range, and no history of distant metastatic disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive peposertib orally once daily and undergo IMRT daily Monday-Friday for 7 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Peposertib
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
NRG Oncology
Collaborator