BENITIONSClinical Trial Intelligence

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

1/2상 진행 중(모집 완료) NCT01064648

대상 질환Epithelioid Mesothelioma, Pleural Malignant Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatoid Mesothelioma
임상 단계1/2상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수117 명
중재(약물)Cediranib Maleate, Cisplatin, Laboratory Biomarker Analysis, Pemetrexed Disodium, Placebo Administration
시작일2010년 3월 15일
완료일2018년 6월 1일
결과 공개일2020년 2월 5일

요약

This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and to see how well it works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.

Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)

Weekly during first cycle (1cycle = 21 days). Then will be reported every cycle while patient is on treatment. · mg

All Phase I Participants20 mg

Progression-free Survival (Phase II)

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever came first, assessed up to 5 years.Disease assessment will be repeated every 6 weeks until disease progression. · month

Phase II Cisplatin-pemetrexed Cediranib 20mg7.2 month
Phase II Cisplatin-pemetrexed Placebo5.6 month
p-value0.06
Hazard Ratio (HR)0.71 (95% CI 0.54–0.95)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

같은 질환의 다른 임상

전체 임상

이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.