Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE January 27, 2016
First Posted Date  ICMJE January 29, 2016
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE March 7, 2016
Estimated Primary Completion Date December 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Number of patients with Dose Limiting Toxicity (DLT) for nintedanib with weekly docetaxel during the first treatment cycle [ Time Frame: 4 weeks ]
  • Maximum Tolerated Dose (MTD) of nintedanib in association with weekly docetaxel. [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02668393 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Docetaxel
  • Drug: Nintedanib
    Low Dose
  • Drug: Nintedanib
    Medium dose
  • Drug: Nintedanib
    High dose
  • Drug: Nintedanib
    Continuous high dose
Study Arms  ICMJE
  • Level 0
    Nintedanib low dose with docetaxel
    Interventions:
    • Drug: Docetaxel
    • Drug: Nintedanib
  • Level 1
    Nintedanib medium dose with docetaxel
    Interventions:
    • Drug: Docetaxel
    • Drug: Nintedanib
  • Level 2
    Nintedanib high dose with docetaxel
    Interventions:
    • Drug: Docetaxel
    • Drug: Nintedanib
  • Level 3
    Nintedanib continuous high dose with docetaxel
    Interventions:
    • Drug: Docetaxel
    • Drug: Nintedanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 5, 2019)
14
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2016)
30
Estimated Study Completion Date  ICMJE December 5, 2019
Estimated Primary Completion Date December 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02668393
Other Study ID Numbers  ICMJE 1199.224
2015-000317-52 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP