For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.
CLINICAL TRIAL- NCT01907100
Nintedanib (BIBF 1120) in Mesothelioma
Official Title- LUME-Meso: Double Blind Randomized, Multicentre, Phase 11/111 Study of Nintedanib in Combination with Pemetrexed /Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination with Pemextred/ Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients with Unresectable Malignant Pleural Mesothelioma.
Listing on www.clinicaltrials.gov
Sponsor: Boehringer Ingelheim
Location: Multiple locations throughout the world. In the United States, there are 10 different locations.
- University of Alabama at Birmingham Alabama 35249
- University of California San Francisco California 94115
- Rocky Mountain Cancer Centers, Colorado Springs, Colorado 80907
- Comprehensive Cancer Centers of Nevada- Peak Office Henderson, Nevada 89052
- University of Pittsburg Medical Center, Pittsburg Pennsylvania 15232
- Greenville Health System, Greenville South Carolina 29615
- University of Texas MD Anderson Cancer Center, Houston Texas 77030
- Texas Oncology McAllen Texas 78503
- Texas Oncology San Antonio Northeast San Antonio Texas 78217
- Cancer Care Northwest Centers, PS Spokane Valley, Washington 99216
Principal Investigator: Giorgio V. Scagliotti MD, PhD, university of Torino Italy and Nicholas J. Vogelzang MD, Comprehensive Cancer Centers of Nevada- in the United States
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 firstname.lastname@example.org
Number of Participants: Estimated – 537 – September 19, 2013 – October 30,2019
Purpose: This is a Phase ll/lll study to confirm that by adding nintedanib (BIBF 1120) in combination with first line therapy pemextred and cisplatin in one arm of the study- and a second arm having the first line therapy pemextred and cisplatin along with a placebo instead of Nintedanib.
The study will then primarily measure progression free survival measured by the time of randomization for the trial until disease progression, or death from any cause, whichever happens first. The time frame for this follow up is up to 3 years.
The secondary outcomes that will be measured are overall survival measured from the time of randomization to the time of death of any cause. Objective response according to the modified RECIST score. Disease control measured according to modified RECIST by disease control rate. The time frame on all these objectives is up to 3 years.
Screening: 18 years or older- male or female
Not have sarcomatoid sub type of malignant pleural mesothelioma
Eligibility Criteria: Histologically confirmed malignant pleural mesothelioma – Phase ll epithelioid or biphasic subtype only- Phase lll epithelioid subtype only
- Life expectancy of at least 3 months- decision by the investigator
- Eastern Cooperative Oncology Group (EGOG) score of 0 or1
- Measurable disease according to modified RECIST (Response Evaluation in Solid Tumors) criteria
Exclusion Criteria: Previous systemic chemotherapy for malignant pleural mesothelioma
Prior treatment with Nintedanib or any other prior line of therapy
Phase ll patients with sarcomatoid subtype malignant pleural mesothelioma or Phase
lll patients with biphasic or sarcomatoid subtype malignant pleural mesothelioma
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 tumors or local invasion of major blood
Vessels by malignant pleural mesothelioma
Significant cardiovascular diseases
Inadequate hematologic, renal, or hepatic function
How the Research Study is Designed to Work: By administering Nintedanib and a placebo to two different randomized groups of patients who have epithelial type malignant pleural mesothelioma, along with the first line chemotherapy agents, cisplatin and pemextred. The results will then be analyzed with attention to overall survival, time to progression of disease recurrence, and time toward death by any cause.
With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials. Please do not hesitate to reach out with any questions.