At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 58 enrolled
Drug / intervention
Cetuximab( erbitux®) +1 moredrug
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.
A Phase Ib Dose Escalation Study of Afatinib in Combination With Cetuximab in Patients With Advanced Solid Tumours
In Brief
A Phase 1 clinical trial evaluating Cetuximab( erbitux®) and Afatinib for Neoplasms. Completed, enrolled 58 participants across 2 sites in 2 countries.
Detailed Summary
The trial is divided in two parts, Part A and Part B. Part A will involve dose-finding of dose-limiting toxicity (DLT) and MTD in patients with advanced solid tumours. Part B will involve expansion of the MTD to 3 cohorts including non-small cell lung cancer squamous histology, recurrent/ metastatic squamous cell carcinoma of head and neck and other advanced solid tumours (except sarcomas).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesFrance, Spain
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedDec 2013
Primary CompletionJan 2015
Study CompletionApr 2016
TodayJul 2026
First PostedDec 25, 2013
Enrollment StartDec 1, 2013
Primary CompletionJan 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.5 years ago
Interventions
Cetuximab( erbitux®)drug
once per week
Afatinibdrug
once per day