Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

NCT02668393 | Completed Phase 1 Results

• 2 other identifiers: 1199.2242015-000317-52
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 4

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• 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.

  First treatment cycle, the first 28 days following the start of trial medication.

• 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.

  First treatment cycle, the first 28 days following the start of trial medication.

Study Arms (4)

Level 0

OTHER

Nintedanib low dose with docetaxel

Drug: Docetaxel; Drug: Nintedanib

Level 1

OTHER

Nintedanib medium dose with docetaxel

Drug: Docetaxel; Drug: Nintedanib

Level 2

OTHER

Nintedanib high dose with docetaxel

Drug: Docetaxel; Drug: Nintedanib

Level 3

OTHER

Nintedanib continuous high dose with docetaxel

Drug: Docetaxel; Drug: Nintedanib

Interventions

Docetaxel DRUG

Level 0; Level 1; Level 2; Level 3

Nintedanib DRUG

Low Dose

Level 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

HOP d'Angers

Angers, 49 933, France

Location

HOP Jean Minjoz

Besançon, 25030, France

Location

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, 06120, Germany

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; nintedanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

Recruitment was prematurely discontinued after dose level 2 (200 milligram) due to difficulties in recruiting subjects.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: March 7, 2016
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: January 29, 2021
• Results First Posted: January 29, 2021

Record last verified: 2021-01

Locations

FR (2); DE (2)