LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma
Stopped: Low enrollment
United States5 participantsStarted 2017-11-10
Plain-language summary
The purpose of this trial is to evaluate the disease control rate of nintedanib in subjects with metastatic appendiceal cancer for whom initial fluoropyrimidine-based chemotherapy has failed. Based on previous studies, the anticancer activity of nintedanib in lung and ovarian cancer trials, along with the similarities between appendiceal and colorectal cancer and potentially ovarian cancer, warrant additional investigation for the optimal treatment of metastatic appendiceal carcinomas.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age at least 18 years old
✓. Histologically confirmed appendiceal carcinoma stage IV
✓. Failure of initial fluoropyrimidine -based chemotherapy. Failure is defined as progression on or within 6 months of last day of therapy or intolerance of initial fluoropyrimidine-based chemotherapy.
✓. Life expectancy at least 3 months
✓. ECOG performance status score 0-2
✓. Presence of measurable and/or evaluable, non-measurable disease according to RECIST 1.1 criteria
✓. Written informed consent signed and dated by subject or Legally Authorized Representative (LAR) prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation.
Exclusion criteria
✕. Prior treatment with nintedanib or any other VEGFR inhibitor
✕. Known hypersensitivity to peanut or soya or to contrast media. History of hypersensitivity to contrast media is allowed if the subject is able to tolerate contrast media with pre-medication.
What they're measuring
1
Disease Control Rate
Timeframe: From first dose of study drug to date of progression as determined by RECIST 1.1, assessed up to 7.5 months.
✕. Chemo-, hormone-, radio-(except for brain and extremities) or immunotherapy, or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug.
✕. Radiotherapy to any target lesion within the past 3 months prior to baseline imaging when that target lesion is the only target lesion identified on baseline imaging, unless it has subsequently grown.
✕. Persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy as determined by the investigator.
✕. Active brain metastases (e.g. stable for \<4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month) or leptomeningeal disease.
✕. Radiographic evidence of cavitary or necrotic tumors.
✕. Tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels.