Clinical Trial: NCT02668393 - My Cancer Genome

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

URL:

https://clinicaltrials.gov/show/NCT02668393

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

Drug	Synonyms	Arms
Docetaxel		Level 0
Nintedanib		Level 0
Nintedanib		Level 1
Nintedanib		Level 2
Nintedanib		Level 3

Purpose

Trial Arms

Name	Type	Description	Interventions
Level 0	Other	Nintedanib low dose with docetaxel	Docetaxel Nintedanib
Level 1	Other	Nintedanib medium dose with docetaxel	Docetaxel Nintedanib
Level 2	Other	Nintedanib high dose with docetaxel	Docetaxel Nintedanib
Level 3	Other	Nintedanib 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

Clinical Trials /

Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma