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ホフマン・ラ・ロシュがスポンサーとなったペルツズマブ臨床試験に以前登録された固形腫瘍患者におけるペルツズマブの安全性および有効性延長試験

基本情報

NCT ID
NCT02320435
ステータス
実施中(募集終了)
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
154
治験依頼者名
Hoffmann-La Roche

概要

This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.

対象疾患

固形腫瘍

介入

Pertuzumab(DRUG)
Trastuzumab(DRUG)
Other Combination Anti-Cancer Therapies(DRUG)

依頼者(Sponsor)

実施施設 (3)

埼玉県立がんセンター

Saitama, Japan

国立研究開発法人国立がん研究センター中央病院

Chiba, Japan

岐阜大学医学部附属病院

Gifu, Japan