Clinical Trials /

Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

NCT02668393

Description:

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.

Related Conditions:
  • Lung Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 1199.224
  • SECONDARY ID: 2015-000317-52
  • NCT ID: NCT02668393

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
DocetaxelLevel 0
NintedanibLevel 0
NintedanibLevel 1
NintedanibLevel 2
NintedanibLevel 3

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Level 0OtherNintedanib low dose with docetaxel
  • Docetaxel
  • Nintedanib
Level 1OtherNintedanib medium dose with docetaxel
  • Docetaxel
  • Nintedanib
Level 2OtherNintedanib high dose with docetaxel
  • Docetaxel
  • Nintedanib
Level 3OtherNintedanib continuous high dose with docetaxel
  • Docetaxel
  • Nintedanib

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients with Dose Limiting Toxicity (DLT) for nintedanib with weekly docetaxel during the first treatment cycle
Time Frame:4 weeks
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Boehringer Ingelheim

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