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.
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.
Completed
Phase 1
Drug | Synonyms | Arms |
---|---|---|
Docetaxel | Level 0 | |
Nintedanib | Level 0 | |
Nintedanib | Level 1 | |
Nintedanib | Level 2 | |
Nintedanib | Level 3 |
Name | Type | Description | Interventions |
---|---|---|---|
Level 0 | Other | Nintedanib low dose with docetaxel |
|
Level 1 | Other | Nintedanib medium dose with docetaxel |
|
Level 2 | Other | Nintedanib high dose with docetaxel |
|
Level 3 | Other | Nintedanib continuous high dose with docetaxel |
|
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 |
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: |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Boehringer Ingelheim |