Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

Phase 1

Completed

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

• Registration Number: NCT02668393
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-29
• Study Start: 2016-03-07
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Results First Submitted: 2020-11-24
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Results First Posted: 2021-01-29
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Level 3	Docetaxel	Nintedanib continuous high dose with docetaxel
Level 2	Nintedanib	Nintedanib high dose with docetaxel
Level 0	Docetaxel	Nintedanib low dose with docetaxel
Level 0	Nintedanib	Nintedanib low dose with docetaxel
Level 2	Docetaxel	Nintedanib high dose with docetaxel
Level 1	Nintedanib	Nintedanib medium dose with docetaxel
Level 1	Docetaxel	Nintedanib medium dose with docetaxel
Level 3	Nintedanib	Nintedanib continuous high dose with docetaxel

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel	First treatment cycle, the first 28 days following the start of trial medication.	Maximum tolerated dose (MTD) of nintedanib administered in combination with docetaxel. The MTD was defined as the highest dose combination studied for which the incidence of DLTs was no more than 1 out of 6 subjects experiencing a DLT during the first treatment cycle i.e. the incidence of DLTs was no more than 17%. In case dose escalation reached dose level 3 (200 mg bid nintedanib administered without interruption on days of docetaxel infusion) and no more than 1 out of 6 subjects experienced a DLT during the first 28-day cycle at this dose level, dose level 3 was considered the MTD.
Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle	First treatment cycle, the first 28 days following the start of trial medication.	Number of participants with DLT occurring during the first treatment cycle. DLT was defined as any of the following adverse events related to nintedanib: * Non-haematological drug-related Common Terminology Criteria for AEs (CTCAE) grade 3 or greater; * diarrhoea CTCAE grade 2 for \>7 days despite supportive care; * nausea CTCAE grade 3 or greater despite supportive care; * vomiting CTCAE grade 2 or greater despite supportive care; * increase in Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) to CTCAE grade 3 or greater; * A increase in ALT and/or AST to CTCAE grade 2 or greater in conjunction with; * total bilirubin increase of CTCAE grade 1 or greater; * Platelets \<50 000/mm3 with bleeding (CTCAE ≥3); * neutropenia of any grade or duration accompanied by fever \>38.5°C; * neutropenia grade 4 without fever of \>7 days duration; * Inability to resume nintedanib dosing within 21 days after stopping due to toxicity.

Trial Locations

Locations (4)

HOP d'Angers; 🇫🇷 Angers, France

HOP Jean Minjoz; 🇫🇷 Besançon, France

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH; 🇩🇪 Großhansdorf, Germany

Krankenhaus Martha-Maria Halle-Dölau gGmbH; 🇩🇪 Halle/Saale, Germany