JPRN-UMIN000009498已完成1 期
A Phase I/II, open-label, non-randomized, multi-center, dose escalation study of olaparib in combination with eribulin mesylate to assess the safety, tolerability, and efficacy in patients with recurrent or metastatic triple-negative-type breast cancer, who have received anthracycline and taxane agents - A Phase I/II study of olaparib in combination with eribulin mesylate in patients with TNBC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
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
- 18years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1)Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant 2)Patients who received treatment (chemotherapy or study treatment) within 1 week from the last administration or underwent treatment procedures (surgery or exposure to radiation) within the 2 weeks preceding enrollment 3)Patients with respiratory failure requiring oxygen inhalation therapy 4)Patients requiring therapeutic dosages of warfarin or related agents 5)Patients with signs or symptoms of interstitial pneumonia or pulmonary fibrosis 6)Patients who are HBs antigen-positive, HCV antibody-positive and/or HIV antibody-positive (Patients who are HBV-DNA positive and/or HCV-RNA positive are cannot be allowed) 7)Patients with serious cardiovascular disease 8)Patients with diabetes mellitus associated with poor glycemic control or receiving insulin 9)Patients with metastases to brain 10)Patients with meningeal carcinomatosis 11)Patients with gastrointestinal obstruction or the symptoms of it 12)Patients with synchronous double cancer, not including lesions equivalent to carcinoma in situ or mucosal carcinoma considered healed with topical therapy 13)Patients who have no features suggestive of MDS/AML on peripheral blood smear 14)Patients receiving the following classes of CYP3A4 inhibitors and inducers -CYP3A4 inhibitors: Azole antifungals, Macrolide antibiotics, Protease inhibitors -CYP3A4 inducers: Phenytoin, Rifampicin, Carbamazepine, Barbiturate derivatives 15)Patients with history of treatment with or allergy to eribulin mesylate Patients with history of treatment with or allergy to PARP inhibitors
研究者
相似试验
招募中
1 期
A study to test different doses of BI 764532 combined with ezabenlimab in patients with Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3.Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3.JPRN-jRCT2031220716Mori Hiroko4
已完成
1 期
Phase I Non-Randomized Single sequence Drug Drug interaction studyCTRI/2022/12/048142Hetero Labs Limited
进行中（未招募）
1 期
Cross-vaccination study of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in subjects who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies.MedDRA version: 18.1 Level: LLT Classification code 10019982 Term: Herpes zoster NOS System Organ Class: 100000004862Herpes ZosterEUCTR2015-000965-30-FIGlaxoSmithKline Biologicals14,550
进行中（未招募）
1 期
Cross-vaccination study of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in subjects who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies.MedDRA version: 20.0 Level: LLT Classification code 10019982 Term: Herpes zoster NOS System Organ Class: 100000004862Herpes ZosterEUCTR2015-000965-30-DEGlaxoSmithKline Biologicals14,550
进行中（未招募）
1 期
Cross-vaccination study of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in subjects who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies.Herpes ZosterEUCTR2015-000965-30-FRGlaxoSmithKline Biologicals14,550