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
第1/2相
実施中(募集終了)
NCT01386385
| 対象疾患 | Lung Adenocarcinoma, Lung Adenocarcinoma, Mixed Subtype, Lung Large Cell Carcinoma, Lung Squamous Cell Carcinoma |
|---|
| 相 | 第1/2相 |
|---|
| スポンサー | National Cancer Institute (NCI) |
|---|
| ステータス | 実施中(募集終了) |
|---|
| 参加者数 | 53 名 |
|---|
| 介入(薬剤) | 3-Dimensional Conformal Radiation Therapy, Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Placebo Administration |
|---|
| 開始日 | 2011年6月20日 |
|---|
| 完了日 | 2019年5月26日 |
|---|
| 結果公開日 | 2021年7月12日 |
|---|
概要
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 |
|---|
| Phase I 80mg Veliparib | 1 dose limiting toxicity |
|---|
| Phase I 120mg Veliparib | 0 dose limiting toxicity |
|---|
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 |
|---|
| Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel) | 9.9 months |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
同じ疾患の他の治験
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。