Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
1/2상
진행 중(모집 완료)
NCT01386385
| 대상 질환 | Lung Adenocarcinoma, Lung Adenocarcinoma, Mixed Subtype, Lung Large Cell Carcinoma, Lung Squamous Cell Carcinoma |
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| 임상 단계 | 1/2상 |
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| 스폰서 | National Cancer Institute (NCI) |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 53 명 |
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| 중재(약물) | 3-Dimensional Conformal Radiation Therapy, Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Placebo Administration |
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| 시작일 | 2011년 6월 20일 |
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| 완료일 | 2019년 5월 26일 |
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| 결과 공개일 | 2021년 7월 12일 |
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요약
This phase I/II partially randomized trial studies the side effects and best dose of veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see how well it works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. It is not yet known whether radiation therapy, carboplatin, and paclitaxel are more effective with or without veliparib in treating non-small cell lung cancer.
Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I)
9 weeks · dose limiting toxicity
| Phase I 40mg Veliparib | 1 dose limiting toxicity |
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| Phase I 80mg Veliparib | 1 dose limiting toxicity |
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| Phase I 120mg Veliparib | 0 dose limiting toxicity |
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Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II)
The time from randomization to progression or death due to any cause, assessed up to 5 years · months
| Arm I (RT, Veliparib, Carboplatin, Paclitaxel) | 9.3 months |
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| Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel) | 9.9 months |
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