Nintedanib (BIBF 1120) in Mesothelioma
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/20/2019 |
| Start Date: | September 19, 2013 |
| End Date: | August 31, 2018 |
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
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.
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.
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
We found this trial at
11
sites
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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