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Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Docetaxel
Nintedanib
Nintedanib
Nintedanib
Nintedanib
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

-Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible).

First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.

  • ECOG inferior or equal to 1 at screening.
  • Further inclusion criteria apply

Exclusion criteria:

  • Patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic NSCLC.
  • Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or patients known to be positive for ALK translocation
  • Further exclusion criteria apply.

Sites / Locations

  • HOP d'Angers
  • HOP Jean Minjoz
  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
  • Krankenhaus Martha-Maria Halle-Dölau gGmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Level 0

Level 1

Level 2

Level 3

Arm Description

Nintedanib low dose with docetaxel

Nintedanib medium dose with docetaxel

Nintedanib high dose with docetaxel

Nintedanib continuous high dose with docetaxel

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel
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
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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2016
Last Updated
January 11, 2021
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02668393
Brief Title
Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
Official Title
An Open Label Phase I of Oral Nintedanib Plus Weekly Docetaxel Therapy in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma After Failure of Platinum -Based First Line Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2016 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Level 0
Arm Type
Other
Arm Description
Nintedanib low dose with docetaxel
Arm Title
Level 1
Arm Type
Other
Arm Description
Nintedanib medium dose with docetaxel
Arm Title
Level 2
Arm Type
Other
Arm Description
Nintedanib high dose with docetaxel
Arm Title
Level 3
Arm Type
Other
Arm Description
Nintedanib continuous high dose with docetaxel
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Intervention Description
Low Dose
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Intervention Description
Medium dose
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Intervention Description
High dose
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Intervention Description
Continuous high dose
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel
Description
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.
Time Frame
First treatment cycle, the first 28 days following the start of trial medication.
Title
Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle
Description
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.
Time Frame
First treatment cycle, the first 28 days following the start of trial medication.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: -Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible). First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed. ECOG inferior or equal to 1 at screening. Further inclusion criteria apply Exclusion criteria: Patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic NSCLC. Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or patients known to be positive for ALK translocation Further exclusion criteria apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
HOP d'Angers
City
Angers
ZIP/Postal Code
49 933
Country
France
Facility Name
HOP Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Dölau gGmbH
City
Halle/Saale
ZIP/Postal Code
06120
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

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Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

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