EUCTR2011-002570-23-DE进行中（未招募）不适用
An open-label, single-arm, multi-center phase II study to evaluate the efficacy and safety of AUY922 in combination with trastuzumab standard therapy as second-line treatment in patients with HER2-positive advanced gastric cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •- Written informed consent obtained prior to any screening procedures
- •- Patients with documented cytological or histological confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and proven HER2 positive.
- •- Patients with progressive disease (radiological confirmation required according to RECIST) after first line of trastuzumab in combination with chemotherapy for advanced gastric cancer.
- •- Age = 18 years or age of consent in country of residence and able to sign Informed Consent
- •- ECOG performance status of 0-1 at study entry
- •- HER2-overexpressing positive gastric tumor by IHC3+ or IHC2+ with positive in situ hybridization
- •- Measurable disease according to RECIST (Irradiated lesions can not be considered measurable unless they have clearly progressed since radiotherapy).
- •- Negative serum pregnancy test. The serum pregnancy test must be obtained prior to any drug administration (= 72 hours prior to dosing) in all pre-menopausal women and for women < 2 years after the onset of menopause.
- •- Patients must have hematologic and biochemistry laboratory values as defined in the protocol
- •Other inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients eligible for this study must not meet any of the following criteria:
- •- Evidence of spinal cord compression or current evidence of CNS metastases. CT/MRI of the brain is mandatory (within 3 weeks before study start) in case of clinical suspicion or evidence of brain metastases
- •- Patient must be = 4 weeks since last chemotherapy or treatment with another systemic anti-cancer agent. Patients must have recovered (CTC = 1) from acute toxicities of any previous therapy (with the exception of alopecia).
- •- Patients may have received prior radiotherapy for management of local disease providing that disease progression has been documented, all toxicities have resolved (CTC = 1) (with the exception of alopecia), and the last fraction of radiotherapy was completed at least 4 weeks prior to the study.
- •- Prior treatment with an agent that acts via HER2/c-erbB2 targeting other than 1st line trastuzumab, include (but are not limited to) lapatinib and pertuzumab.
- •- Treatment with therapeutic doses of coumarin-type anticoagulants. (Maximum daily dose of 2 mg, for line patency permitted)
- •- Patients with malignant ascites that require invasive treatment
- •- Patients with acute or chronic renal disease; and active and chronic liver disease requiring intervention. Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.
- •- Major surgery = 2 weeks prior to enrollment or who have not recovered from such therapy
- •- Impaired cardiac function
- •- Concurrent malignancies or invasive cancers diagnosed within the past 5 years, except for adequately treated basal cell cancer of the skin or in situ cancer of the cervix
- •- Patients receiving chronic or high dose corticosteroids therapy (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed)
- •- Patients unwilling or unable to comply with the protocol
- •- Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggesting HIV infection.
- •- Known hypersensitivity to any of the study drugs or their excipients
- •- Participation in another clinical study within 30 days before first study treatment
- •- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
- •- Fertile women of childbearing potential (WOCBP) not using adequate contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
- •Other exclusion criteria may apply.
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