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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 3 Interventional 18 Years and older Boehringer Ingelheim 1199.93
2012-005201-48
NCT01907100
Enrolling patients

Study Design:


Principal Investigator

Professor of Medicine
Chair, Data and Safety Monitoring Committee
Bonnie J. and Anthony Addario Endowed Chair in Thoracic Oncology
UCSF Helen Diller Family Comprehensive Cancer Center

Clinical Research Coordinator

UCSF Helen Diller Family Comprehensive Cancer Center
(415) 514-6241 Phone
(415) 353-9721 Fax

Trial 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.

Eligibility

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

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 4/28/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
X