Status:
COMPLETED
IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Assuntina G. Sacco, MD
Collaborating Sponsors:
The V Foundation for Cancer Research
Conditions:
Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Admi...
Detailed Description
This is a phase 2 window of opportunity trial in patients with locally advanced head and neck cancer. A key objective is to provide the first proof that macrophage phenotype switching can be accomplis...
Eligibility Criteria
Inclusion
- Have locally advanced that is amenable to surgical resection
- Must be able to swallow tablets
- Must be able to undergo a core tumor biopsy.
- Must have adequate organ function.
Exclusion
- Diagnosis of cutaneous squamous cell carcinoma (SCC) or Epstein-Barr virus (EBV) related nasopharynx cancer.
- Planned major surgery within 4 weeks prior to initiation of study drug
- Patients treated with chemotherapy, biologic therapy, or other investigational agent within \< 28 days of starting study drug
- History of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus (HCV)
- On going treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids
- Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g. gastric bypass surgery, gastrectomy)
- Female subjects who are pregnant or breastfeeding
- Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia
Key Trial Info
Start Date :
March 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03795610
Start Date
March 6 2020
End Date
August 24 2023
Last Update
July 25 2025
Active Locations (1)
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1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093