At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 10 enrolled
Drug / intervention
Nintedanib +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.
An Open Label Phase I Safety run-in Trial of Oral Nintedanib Plus Docetaxel Therapy in Japanese Patients With Locally Advanced or Metastatic Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of Platinum-based First Line Chemotherapy
In Brief
A Phase 1 clinical trial evaluating Nintedanib and Docetaxel for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 10 participants across 6 sites.
Detailed Summary
To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75 mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area (BSA) \<1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer (NSCLC) after failure of first line platinum- based chemotherapy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartDec 2014
Primary CompletionJan 2016
Study CompletionOct 2017
TodayJul 2026
First PostedNov 25, 2014
Enrollment StartDec 24, 2014
Primary CompletionJan 15, 2016
Study CompletionOct 27, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.6 years ago
Interventions
Nintedanibdrug
Nintedanib
Docetaxeldrug
Docetaxel