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Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02668393
Recruitment Status : Completed
First Posted : January 29, 2016
Results First Posted : January 29, 2021
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Docetaxel Drug: Nintedanib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 7, 2016
Actual Primary Completion Date : November 27, 2019
Actual Study Completion Date : November 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Level 0
Nintedanib low dose with docetaxel
Drug: Docetaxel
Drug: Nintedanib
Low Dose

Level 1
Nintedanib medium dose with docetaxel
Drug: Docetaxel
Drug: Nintedanib
Medium dose

Level 2
Nintedanib high dose with docetaxel
Drug: Docetaxel
Drug: Nintedanib
High dose

Level 3
Nintedanib continuous high dose with docetaxel
Drug: Docetaxel
Drug: Nintedanib
Continuous high dose




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel [ Time Frame: 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.

  2. Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668393


Locations
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France
HOP d'Angers
Angers, France, 49 933
HOP Jean Minjoz
Besançon, France, 25030
Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle/Saale, Germany, 06120
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] November 4, 2015
Statistical Analysis Plan  [PDF] February 21, 2017

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02668393    
Other Study ID Numbers: 1199.224
2015-000317-52 ( EudraCT Number )
First Posted: January 29, 2016    Key Record Dates
Results First Posted: January 29, 2021
Last Update Posted: January 29, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma of Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Nintedanib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors