Study of the Combination of Tivantinib Plus Pemetrexed and Carboplatin (NCT02049060) | Clinical Trial Compass
CompletedPhase 1/2
Study of the Combination of Tivantinib Plus Pemetrexed and Carboplatin
Italy31 participantsStarted 2013-01
Plain-language summary
This is a prospective, open-label, mono-centric, phase I-Ib trial of Tivantinib in combination with Pemetrexed and Carboplatin as first-line therapy in patients with advanced or metastatic cancer suitable for a Carboplatin and Pemetrexed regimen as part of their specific therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients must be diagnosed with MPM or non squamous NSCLC.
✓. Inoperable disease according to local surgeon, not previously treated with chemotherapy; patients relapsed/progressed after previous surgery will be also evaluable for inclusion.
✓. Age \> 18.
✓. ECOG Performance Status 0-1 and life expectancy of at least 12 weeks.
✓. Measurable and/or evaluable lesions according to modified RECIST criteria \[51\].
✓. Written informed consent.
✓. Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center.
✓. Patients must use effective contraception during the study lasting at least one month after the end of treatment for both sexes.
Exclusion criteria
✕. Any prior chemotherapy (including intracavitary administration).
✕. Symptomatic and/or unstable pre-existing brain metastases.To be enrolled in the study , subjects must have confirmation of stable disease by MRI or computer tomography (CT) scan within 4 weeks from day 1 of cycle 1 of treatment and have CNS metastases well controlled by steroids, anti - epileptics or other symptom-relieving medications
✕. Serious non-healing wound or ulcer.
What they're measuring
1
To determine the dose limiting toxicities (DLTs) of Tivantinib