CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Axitinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02762513
NCT02762513Phase 2Completed

Phase II Expansion Trial Evaluating Axitinib in Patients With Unresectable Recurrent, or Metastatic Head and Neck Cancer Utilizing Choi Response Criteria Phase

University of Michigan Rogel Cancer Center·interventional·Posted May 5, 2016·Updated May 5, 2021

In Brief

A Phase 2 clinical trial evaluating Axitinib for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 29 participants across 1 site.

Detailed Summary

This study will be a prospective, single-institution, single-arm phase II study of Axitinib in patients with unresectable recurrent and metastatic head and neck squamous cell carcinoma. The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic response assessment after 8 weeks and subsequently every 2 months until disease progression or intolerable toxicity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 5, 2016
Enrollment StartAug 30, 2016
Primary CompletionApr 9, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.2 years ago

Interventions

Axitinibdrug