Status:
COMPLETED
Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75 mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area (BSA) \<1.5 m2 an...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients aged 20 years or older at the date of informed consent
- Patients with body surface area (BSA)\<1.5 m2 at screening
- Patients with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer (NSCLC) 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 is accepted.
- Patients who have life expectancy of at least 3 months
- Patients who are Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening
- Patients obtained written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP)and Japanese GCP
- 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 (Prior monotherapies with an epidermal growth factor receptor tyrosine kinase inhibitors \[EGFR-TKI\]) or anaplastic lymphoma kinase (ALK) inhibitor can be allowed)
- Patients who have received previous therapy with other vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) inhibitors (other than bevacizumab) for the treatment of NSCLC at any time
- Patients who have received following treatments within 4 weeks prior to start of study therapy 1) Other investigational drugs 2) Chemo-, hormone-, immunotherapy, or monoclonal antibody.
- Patients who have received molecular target therapy including EGFR TKIs and ALK inhibitors within 2 weeks prior to start of study therapy
- Patents who have received radiotherapy within the past 3 months (in the case of limited -field \[e.g. brain or bone metastasis\] radiotherapy with palliative intent), within 2 weeks) prior to start of study therapy
- Patients who not recovered clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy (=CTCAE grade 2 Adverse Event from previous treatment) at screening
- further exclusion criteria may be applied
Exclusion
Key Trial Info
Start Date :
December 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02300298
Start Date
December 24 2014
End Date
October 27 2017
Last Update
February 11 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
1199.90.81001 Boehringer Ingelheim Investigational Site
Chiba , Kashiwa, Japan
2
1199.90.81003 Boehringer Ingelheim Investigational Site
Kanagawa, Yokohama, Japan
3
1199.90.81007 Boehringer Ingelheim Investigational Site
Osaka, Osakasayama, Japan
4
1199.90.81006 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan