A Double Blind, Placebo Controlled, Randomized Phase II Study Evaluating Gemcitabine With or With… (NCT03560973) | Clinical Trial Compass
CompletedPhase 2
A Double Blind, Placebo Controlled, Randomized Phase II Study Evaluating Gemcitabine With or Without Ramucirumab , for II Line Treatment MPM
Italy164 participantsStarted 2016-12-22
Plain-language summary
Study RAMES is a multicentre, double-blind, randomized Phase II study exploring the efficacy and evaluating the safety of the addition of ramucirumab to gemcitabine as the second-line treatment of patients with diffuse pleural mesothelioma. Patients will be randomly assigned (1:1) to receive intravenous gemcitabine 1000 mg/m2 on days 1 and 8 every 21 days with placebo or combined with intravenous ramucirumab 10 mg/Kg (ramucirumab group) on day 1 of a 21 day cycle until PD. Randomisation will be done via a centralized system and will stratified by performance status (0-1 vs 2), age (≤70 vs \>70), histology (epithelioid vs others), time to progression (TTP) after a previous treatment (first line therapy, adjuvant or neoadjuvant therapy) (\< 6 months vs ≥6 months).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The patient has a histopathologically or cytologically confirmed diagnosis of malignant pleural mesothelioma.
✓. The patient has documented disease progression after the last dose of first-line chemotherapy for metastatic disease,
✓. The patient received combination chemotherapy prior to disease progression.
✓. Prior chemotherapy regimens must include a platinum or pemetrexed component. Exposure to antineoplastic therapy, in addition to platinum and/or pemetrexed, is acceptable if the agents were used in the first-line metastatic or neoadjuvant/adjuvant setting.
✓. Patients who have had one or more components of first-line chemotherapy discontinued because of toxicity, but continued to receive the other component(s), are eligible following disease progression.
✓. The patient has metastatic disease or locally advanced disease that is measurable, or nonmeasurable but evaluable, by radiological imaging per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) (Eisenhauer et al. 2009 Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using intravenous and oral contrast unless clinically contraindicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed.
✓. The patient has an ECOG performance status of 0-2
What they're measuring
1
OS
Timeframe: 36 months
Trial details
NCT IDNCT03560973
SponsorGruppo Oncologico Italiano di Ricerca Clinica
✕4. The patient has cancer with histology other than mesothelioma.
✕5. The patient is receiving chronic therapy with any of the following within 7 days prior to randomization:
✕. nonsteroidal anti-inflammatory agents (NSAIDs; such as indomethacin, ibuprofen, naproxen, or similar agents)
✕. other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or anagrelide) Aspirin use at doses up to 325 mg/day is permitted.
✕6. The patient received radiotherapy within 14 days prior to randomization. Any lesion requiring palliative radiotherapy or which has been previously irradiated cannot be considered for response assessment.
✕7. The patient received \>1 line of prior therapy for the treatment MPM.
✕8. The patient received previous treatment with agents targeting the VEGF/VEGF Receptor 2 signaling pathway, including previous exposure to ramucirumab.
✕9. The patient has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression. Screening of asymptomatic patients is not required.