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

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Nintedanib; Drug: Docetaxel

• Registration Number: NCT02300298
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Study Start: 2014-12-24
• Primary Completion: 2016-01-15
• Results First Submitted: 2017-01-12
• Study Completion: 2017-10-27
• Results First Submitted QC: 2017-11-07
• Results First Posted: 2018-08-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nintedanib plus Docetaxel	Nintedanib	patients to receive backbone chemotherapy and nintedanib
Nintedanib plus Docetaxel	Docetaxel	patients to receive backbone chemotherapy and nintedanib

Primary Outcome Measures

Name	Time	Method
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1	Cycle 1, from first administration of study medication up to 21 days thereafter.	DLT was defined as any of the following study drug related adverse events (AEs): * Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 non-haematological toxicity except transient electrolyte abnormality and isolated increase of gamma-glutamyltransferase (GGT); gastrointestinal toxicity, despite adequate supportive care; * CTCAE grade 4 haematological toxicity; Neutrophil count decreased or white blood cell count (not associated with fever) for \>7 days despite adequate supportive treatment; * CTCAE grade 4 febrile neutropenia with fever ≥38.5 degrees; * CTCAE grade ≥2 alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increase in conjunction with CTCAE grade ≥2 total bilirubin increase; * Inability to resume nintedanib dosing within 14 days after stopping Investigators judged clinically as DLT after dose reduction and severity medically notable (CTCAE, version 3). Sponsor with safety review committee was allowed to confirm the adequacy of this judgment.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 to Time of the Last Quantifiable Concentration (AUC0-tz)	At 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 after first drug administration of docetaxel in cycle 1.	This outcome measure presents the area under the concentration-time curve of nintedanib over the time interval from 0 to time of the last quantifiable concentration in plasma (AUC0-tz) in cycle 1.
AUC0-tz of Docetaxel	just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)	This outcome measure presents AUC0-tz of docetaxel in plasma in cycles 1 and 2.
Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)	at 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 h after first drug administration of docetaxel in cycle 1.	This outcome measure presents the Area under the concentration-time curve of nintedanib over the time interval from 0 extrapolated to infinity in plasma (AUC0-infinity) in cycle 1.
AUC0-infinity of Docetaxel	just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)	This outcome measure presents the AUC0-infinity of docetaxel in plasma in cycles 1 and 2.
Maximum Measured Concentration (Cmax) of Nintedanib	At 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 h after first drug administration of docetaxel in cycle 1.	This outcome measure presents the maximum measured concentration (Cmax) of nintedanib in plasma in cycle 1.
Cmax of Docetaxel	just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)	This outcome measure presents the Cmax of docetaxel in plasma in cycles 1 and 2.

Trial Locations

Locations (6)

1199.90.81006 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan

1199.90.81001 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiba , Kashiwa, Japan

1199.90.81003 Boehringer Ingelheim Investigational Site; 🇯🇵 Kanagawa, Yokohama, Japan

1199.90.81007 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osakasayama, Japan

1199.90.81004 Boehringer Ingelheim Investigational Site; 🇯🇵 Shizuoka, Sunto-gun, Japan

1199.90.81002 Boehringer Ingelheim Investigational Site; 🇯🇵 Tokyo, Chuo, Japan