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:

Completed

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:	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.
Safety Issue:
Description:	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.

Details

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

Last Updated

January 29, 2021

Clinical Trials /

Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma