TerminatedPhase 2

Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer

Stopped: Novartis has chosen to withdraw support for this trial

United States9 participantsStarted 2019-03-11

Plain-language summary

This phase II trial studies how well alpelisib works in treating participants with human papillomavirus(HPV)-associated stage I-IVA head and neck cancer that can be removed by surgery. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Cytologic or histologic diagnosis of p16+ squamous cell carcinoma of oropharyngeal or unknown primary metastatic to the cervical met.
✓. p16 positivity is defined as ≥70% of tumor cells demonstrating diffuse cytoplasmic and nuclear staining for p16 by immunohistochemistry in a CLIA certified pathology lab.
✓. Clinical stage I-IVa p16+ oropharyngeal squamous cell carcinoma, based upon the AJCC staging manual, 7th edition.
✓. No evidence of distant metastatic disease.
✓. Appropriate candidate and planned for primary transoral resection and/or neck dissection.
✓. ECOG performance status 0-1 at time of consent.
✓. Clinically or radiologically measurable disease; the primary tumor and/or neck nodes may be measurable according to RECIST 1.1(tumor diameter ≥ 1 cm; short-axis lymph node diameter ≥ 1.5 cm) OR by caliper measurement (tumor diameter ≥ 1 cm).
✓. Adequate hematologic, renal and hepatic function within 4 weeks of registration, as defined by:

Exclusion criteria

✕. Prior therapy for head and neck cancer is not allowed.

What they're measuring

Quantitative Change in the Sum of Response Evaluation Criteria in Solid Tumors (RECIST) -

Timeframe: Baseline up to 28 days

Percent Change in Tumor Size (Change in T) in Patients With Genomic PIK3CA Pathway Alteration (PIK3CA Mutation, Amplification, and Fluorescence in Situ Hybridization [FISH] for PTEN Loss)

Timeframe: Baseline up to 28 days

Trial details

NCT IDNCT03601507

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-24

Results submitted2023-12-22

View on ClinicalTrials.gov More CDKN2A-p16 Positive trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Cytologic or histologic diagnosis of p16+ squamous cell carcinoma of oropharyngeal or unknown primary metastatic to the cervical met.
✓. p16 positivity is defined as ≥70% of tumor cells demonstrating diffuse cytoplasmic and nuclear staining for p16 by immunohistochemistry in a CLIA certified pathology lab.
✓. Clinical stage I-IVa p16+ oropharyngeal squamous cell carcinoma, based upon the AJCC staging manual, 7th edition.
✓. No evidence of distant metastatic disease.
✓. Appropriate candidate and planned for primary transoral resection and/or neck dissection.
✓. ECOG performance status 0-1 at time of consent.
✓. Clinically or radiologically measurable disease; the primary tumor and/or neck nodes may be measurable according to RECIST 1.1(tumor diameter ≥ 1 cm; short-axis lymph node diameter ≥ 1.5 cm) OR by caliper measurement (tumor diameter ≥ 1 cm).
✓. Adequate hematologic, renal and hepatic function within 4 weeks of registration, as defined by:

Exclusion criteria

✕. Prior therapy for head and neck cancer is not allowed.

What they're measuring

Quantitative Change in the Sum of Response Evaluation Criteria in Solid Tumors (RECIST) -

Timeframe: Baseline up to 28 days

Percent Change in Tumor Size (Change in T) in Patients With Genomic PIK3CA Pathway Alteration (PIK3CA Mutation, Amplification, and Fluorescence in Situ Hybridization [FISH] for PTEN Loss)

Timeframe: Baseline up to 28 days