CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
Olaparib +2 moredrug
Likely dose
Olaparib 200 mgfrom 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/NCT01758731
NCT01758731Phase 1Completed
CompareCT.gov

Phase I Trial of Olaparib (AZD2281) in Combination With C225 and Radiation Therapy in Patients With Locally Advanced, Stage IVA-B Squamous Cell Carcinomas of the Head/Neck With Heavy Smoking Histories

University of Colorado, Denver·interventional·Posted Jan 1, 2013·Updated Sep 23, 2019

In Brief

A Phase 1 clinical trial evaluating Olaparib, Cetuximab, and 1 other intervention for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 17 participants across 1 site.

Detailed Summary

This is a research study that plans to learn more about the safety and tolerability of an investigational drug called Olaparib, in combination with radiation therapy and cetuximab. Hypothesis: Intensity modulated radiotherapy with concurrent C225 and Olaparib represents a feasible, biologically-based alternative to standard chemoradiation, with acceptable toxicity, for treatment of locally-advanced HNSCC in patients having a ≥ 10 pack-year smoking history.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Head and Neck
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 1, 2013
Enrollment StartOct 22, 2012
Primary CompletionDec 5, 2016
Study CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.5 years ago

Interventions

Olaparibdrug

Olaparib PO (25, 50, 100 or 200 mg bid) in combination with RT and C225. BID, beginning three days prior to first C225 infusion and discontinued after RT completed.

Cetuximabdrug

Pre-RT cetuximab (C225), 400 mg/m²IV and weekly C225, 250 mg/m2 IV in during RT.

Radiation Therapyradiation

RT to a total dose of 69.3 Gy (primary tumor and involved lymph nodes) in 33 fractions over 6 and 1/2 weeks