CompletedInterventionalPhase 1Last updated Feb 11, 2025

Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

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

Overview

ClinicalTrials.gov ID: NCT02300298
Lead Sponsor: Boehringer IngelheimINDUSTRY
Brief 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 Type

Status

Overall Status: Completed
Start Date: Dec 24, 2014Actual
Primary Completion Date: Jan 15, 2016Actual
Completion Date: Oct 27, 2017Actual

Study Record Dates

First Submitted: Nov 24, 2014
First Submitted that Met QC Criteria: Nov 24, 2014
First Posted: Nov 25, 2014Estimated
Last Update Submitted that Met QC Criteria: Jan 21, 2025
Last Update Posted: Feb 11, 2025Actual
Last Verified: Jan 2025

NCT02668393Completed

Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

NCT00876460Completed

BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I

NCT02231164Terminated

LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

NCT01594125Completed

Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma

NCT01658462Completed

Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer

NCT00118183Completed

Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer