PER-075-11未知未知
AN OPEN-LABEL, MULTICENTER EXTENSION STUDY OF TRASTUZUMAB-MCC-DM1 (T-DM1) ADMINISTERED AS A SINGLE AGENT OR IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS PREVIOUSLY TREATED WITH THE EQUIVALENT T-DM1 REGIMEN IN A GENENTECH AND/OR F. HOFFMANN-LA ROCHE LTD.-SPONSORED T-DM1 STUDY
F. HOFFMANN-LA ROCHE LTD., GENENTECH, INC.,0 个研究点目标入组 1 人开始时间: 2011年10月7日最近更新:
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 90（—）
入选标准
- •1. SIGNED INFORMED CONSENT FORM(S) FOR THIS STUDY
- •2. COMPLETED SINGLE-AGENT T-DM1 OR COMBINATION T-DM1 TREATMENT ON THE PARENT STUDY OR WHO CONTINUE TO RECEIVE SINGLE-AGENT T-DM1 OR COMBINATION T-DM1 TREATMENT AT THE TIME OF THE PARENT STUDY CLOSURE AND RECEIVED THE LAST STUDY-DRUG DOSE WITHIN THE 6 WEEKS PRIOR TO THE FIRST SCHEDULED DOSE OF STUDY THERAPY ON THE EXTENSION STUDY.
- •3. EXPECTATION BY THE INVESTIGATOR THAT THE PATIENT MAY CONTINUE TO BENEFIT FROM ADDITIONAL SINGLE-AGENT T-DM1 OR COMBINATION T-DM1 TREATMENT.
- •4. LVEF ≥ 40% BASELINE WITHIN 30 DAYS PRIOR TO STUDY ENTRY AS DETERMINED BY EITHER ECHO OR MUGA.
- •PATIENTS WITH AN LVEF ≥ 40%-45% MUST HAVE HAD AN ABSOLUTE CHANGE OF <10% FROM BASELINE (USING AS REFERENCE THE BASELINE LVEF FROM THE PARENT STUDY PRIOR TO THE START OF T-DM1 THERAPY).
- •SEE APPENDIX F FOR INSTRUCTIONS IN THE EVENT THAT THE UNAVAILABILITY OF TECHNETIUM-99 (TC-99M) PRECLUDES THE USE OF BONE SCANS OR MUGA SCANS.
排除标准
- •1. ADVERSE EVENT(S) LEADING TO SINGLE-AGENT T-DM1 OR COMBINATION T-DM1 TREATMENT DISCONTINUATION IN THE PARENT STUDY.
- •2. ONGOING SERIOUS ADVERSE EVENT(S) FROM THE PARENT STUDY.
- •3. PROGRESSIVE DISEASE (EXCEPT FOR ISOLATED BRAIN METASTASES UNDER CERTAIN CONDITIONS AS DESCRIBED IN SECTION 3.1) ON SINGLE-AGENT T-DM1 OR A T-DM1-CONTAINING REGIMEN DURING PARENT STUDY OR BEFORE STARTING THE EXTENSION STUDY, WITH THE EXCEPTION OF PATIENTS FROM STUDY TDM4688G WITH EARLY PROGRESSIVE DISEASE WHO WENT ON TO RECEIVE PERTUZUMAB + T-DM1 TREATMENT AND HAVE NOT EXPERIENCED FURTHER DISEASE PROGRESSION ON THE COMBINATION REGIMEN.
- •COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI) SCAN OF THE CHEST, ABDOMEN AND PELVIS IS MANDATORY WITHIN 30 DAYS PRIOR TO STUDY ENTRY.
- •CT OR MRI SCAN OF THE BRAIN IS MANDATORY (WITHIN 30 DAYS PRIOR TO STUDY ENTRY) IN CASES OF CLINICAL SUSPICION OF BRAIN METASTASES.
- •4. PERIPHERAL NEUROPATHY OF GRADE ≥ 3 PER NATIONAL CANCER INSTITUTE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (NCI CTCAE), VERSION 3.0.
研究者
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