Nintedanib (BIBF 1120) in Mesothelioma

Brief Title

Nintedanib (BIBF 1120) in Mesothelioma

Official Title

LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma

Brief Summary

      This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of
      nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF
      1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of
      patients with unresectable malignant pleural mesothelioma.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Progression-Free Survival (PFS)

Secondary Outcome

 Overall Survival (OS)

Condition

Mesothelioma

Intervention

Nintedanib

Study Arms / Comparison Groups

 Placebo + pemetrexed/cisplatin

Description:  Placebo controlled arm

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 19, 2013

Completion Date

August 31, 2018

Primary Completion Date

March 16, 2018

Eligibility Criteria

        Inclusion criteria:

          -  Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic
             subtype for Phase II patients; epithelioid subtype only for Phase III patients)

          -  Life expectancy of at least 3 months in the opinion of the investigator

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

          -  Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid
             Tumours) criteria

        Exclusion criteria:

          -  Previous systemic chemotherapy for MPM

          -  Prior treatment with nintedanib or any other prior line of therapy

          -  Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or
             sarcomatoid subtype MPM

          -  Patients with symptomatic neuropathy

          -  Radiotherapy (except extremities) within 3 months prior to baseline imaging

          -  Active brain metastases (e.g. stable for < 4 weeks)

          -  Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood
             vessels by MPM

          -  Significant cardiovascular diseases

          -  Inadequate hematologic, renal, or hepatic function

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Boehringer Ingelheim, ,

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations

NCT ID

NCT01907100

Organization ID

1199.93

Secondary IDs

2012-005201-48

Responsible Party

Sponsor

Study Sponsor

Boehringer Ingelheim

Study Sponsor

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Verification Date

March 2019