Treating Advanced Head and Neck Cancer with New Combination of Therapies
NCT05172245 · RecruitingThis trial is looking at the safety and best dose of ipatasertib when given with usual treatments for head and neck cancer. The usual treatment includes chemotherapy and radiation therapy. Doctors hope that using ipatasertib might improve the results for patients with advanced head and neck cancer compared to standard treatments alone.
Locations and contact
This trial is running at 18 locations in 2 countries. 13 of them are currently recruiting.
United States17 locations · 13 recruiting
- Moffitt Cancer CenterTampa, FloridaRecruiting
- Montefiore Medical Center - Moses CampusThe Bronx, New YorkRecruiting
- Montefiore Medical Center-Einstein CampusThe Bronx, New YorkRecruiting
- Northwestern UniversityChicago, IllinoisRecruiting
- Rutgers Cancer Institute of New JerseyNew Brunswick, New JerseyRecruiting
- Rutgers New Jersey Medical SchoolNewark, New JerseyRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterCincinnati, OhioRecruiting
- University of Cincinnati Cancer Center-West ChesterWest Chester, OhioRecruiting
- University of Kansas Cancer CenterKansas City, KansasRecruiting
- University of Kansas Clinical Research CenterFairway, KansasRecruiting
- University of Kansas Hospital-Westwood Cancer CenterWestwood, KansasRecruiting
- University of Maryland/Greenebaum Cancer CenterBaltimore, MarylandRecruiting
- VCU Massey Comprehensive Cancer CenterRichmond, VirginiaRecruiting
- Atrium Health Cabarrus/LCI-ConcordConcord, North CarolinaActive Not Recruiting
- Carolinas Medical Center/Levine Cancer InstituteCharlotte, North CarolinaActive Not Recruiting
- University of Kentucky/Markey Cancer CenterLexington, KentuckyActive Not Recruiting
- University of Virginia Cancer CenterCharlottesville, VirginiaSuspended
Canada1 location
- University Health Network-Princess Margaret HospitalToronto, OntarioSuspended
Who can join
This trial is open to adults aged 18 and older, including men and women. Participants must have a confirmed diagnosis of head and neck cancer and be able to swallow tablets. Some specific health criteria apply, which the trial team will check to confirm eligibility.
What happens during the trial
Participants will receive ipatasertib by mouth and also get chemotherapy (cisplatin) through an IV, along with daily radiation therapy. Everyone will be closely monitored and treatments will happen in cycles over a few weeks. There are two parts to the study: a dose escalation part to find the best dose and a dose expansion part for more participants.
The trial team
The trial is sponsored by the National Cancer Institute (NCI). The principal investigator is Dr. Malcolm D. Mattes from the University Health Network Princess Margaret Cancer Center.
Important dates
The trial began on September 19, 2022, and is expected to finish by July 1, 2027. It is currently enrolling new participants.
Additional information
The trial's ID number is NCT05172245. It is a Phase 1 study, which means it focuses on testing how well the treatment works and its safety. This study is regulated by the FDA and plans to include about 46 participants.
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