intedanib (BIBF 1120) in Mesothelioma

Phase 1

• Conditions: nresectable Malignant Pleural Mesothelioma; MedDRA version: 18.1Level: PTClassification code 10059518Term: Pleural mesothelioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005201-48-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm. V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

- Histologically confirmed MPM (subtype: epithelioid or biphasic)
- Life expectancy of at least 3 months in the opinion of the investigator
- ECOG score of 0 or 1
- Measurable disease according to modified RECIST criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 262

Exclusion Criteria

- Previous systemic chemotherapy for MPM
- Prior treatment with nintedanib or any other prior line of therapy
- Patients with sarcomatoid subtype MPM
- Radiotherapy (except extremities) within 3 months prior to baseline imaging
- Patients that may be eligible for or being considered for radical resection or elective surgery during the course of the study.
- Radical surgery within 4 weeks prior to randomisation
- Active brain metastases (e.g. stable for < 4 weeks)
- Therapeutic anticoagulation or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
- Major injuries within the past 4 weeks prior to randomisation with incomplete wound healing
- Other malignancies within 3 years prior to screening other than basal cell skin cancer or carcinoma in situ of the cervix

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified