NL-OMON55556已完成2 期
AIPAC (Active Immunotherapy PAClitaxel): A multicentre, Phase IIb, randomised, double blind, placebo-controlled study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel. - AIPAC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
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 99（—）
入选标准
- •1. Able to give written informed consent and to comply with the protocol
- •2.1 Metastatic oestrogen receptor positive and/or progesterone receptor
- •positive breast adenocarcinoma,
- •histologically proven by biopsy of the primary tumour and/or a metastasis
- •3. Female of age 18 years or above
- •4. Patients who are indicated to receive first line chemotherapy with weekly
- •5.1 All patients of childbearing potential must have a negative highly
- •sensitive pregnancy test at
- •screening and agree to use highly effective method for contraception according
- •to the EU Clinical
- •Trial Facilitation Group guidance from time of study entry until at least 6
- •months after the last
- •administration of study drug. The partners of patients with childbearing
- •potential must also apply
- •contraceptive methods. Patients who are either,
- •o postmenopausal (>= 60 years of age, or < 60 years of age and amenorrhoeic for
- •12 months in the
- •absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression with
- •folliclestimulating
- •hormone (FSH) above 40 U/L and oestradiol below 30 ng/L; or if taking tamoxifen
- •or toremifene, and age < 60 years, then FSH and oestradiol in the
- •postmenopausal range),
- •permanently sterilized (e.g., bilateral tubal occlusion, hysterectomy),
- •o or otherwise be incapable of pregnancy are not considered to be of
- •childbearing potential
- •6. ECOG performance status 0-1
- •7. Expected survival longer than three months
- •8. Resolution of toxicity of prior therapy to grade < 2 (except for alopecia
- •and transaminases in case of
- •liver metastases)
- •9. Evidence of measurable disease as defined by RECIST version 1.1
- •10.1 Laboratory criteria:
- •* Total white cell count >= 3 x 10^9/L
- •* Platelet count >= 100 x 10^9/L
- •* Haemoglobin >= 9 g/dL or 5.58 mmol/L
- •* Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L
- •* Serum creatinine <= 1.5 × ULN
- •* Total bilirubin <= 20 µmol/L, except for familial cholaemia (Gilbert*s disease)
- •* Serum ASAT and ALAT <= 3 times ULN or <=5 times ULN if liver metastases are
排除标准
- •1. Prior chemotherapy for metastatic breast adenocarcinoma
- •2. Disease-free interval of less than twelve months from the last dose of
- •adjuvant chemotherapy
- •3. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue
- •4.1 Inflammatory carcinoma at time of screening
- •5.1 Candidate for treatment with trastuzumab (or other Her2/neu targeted
- •agents) or endocrine based
- •therapy according to the applicable treatment guidelines
- •6.2 Systemic chemotherapy, radiation therapy or any other investigational agent
- •within 4 weeks,
- •endocrine therapy within 1 week or CDK4/6 inhibitors within 5 times half-life
- •(acc. to SPC) prior
- •to first dose of study treatment
- •7.1 Symptomatic known cerebral and/or leptomeningeal metastases
- •8. Women who are pregnant or lactating
- •9. Serious intercurrent infection within 4 weeks prior to first dose of study
- •10. QTcF >480 ms, family or personal history of long or short QT syndrome,
- •Brugada syndrome or
- •known history of QTc prolongation, or Torsade de Pointes (TdP)
- •11. Uncontrolled electrolyte disorders that can worsen the effects of a
- •QTc-prolonging drug (e.g.,
- •hypocalcaemia, hypokalaemia, hypomagnesemia)
- •12.1 Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6
- •months prior to first
- •dose of study treatment including: myocardial infarction, severe/unstable
- •angina, ongoing cardiac
- •dysrhythmias of NCI CTCAE version 4.03 Grade >=2, atrial fibrillation,
- •coronary/peripheral artery
- •bypass graft, symptomatic congestive heart failure, cerebrovascular accident
- •including transient
- •ischemic attack, ventricular arrhythmias requiring medication or symptomatic
- •pulmonary embolism
- •13. Active acute or chronic infection
- •14. Active autoimmune disease requiring immunosuppressive therapy
- •15.1 Positive test for HIV
- •16.1 Positive test for Hepatitis B (anti-HBc) or C (Patients who are anti-HBc+
- •and HBsAg negative are eligible and are not excluded from participation in this
- •17. Life threatening illness unrelated to cancer
- •18. Previous malignancies within the last three years other than breast
- •carcinoma, except successfully
- •treated squamous cell carcinoma of the skin, superficial bladder cancer, and in
- •situ carcinoma of the
- •19. Any current disorder that would impede the patient*s ability to provide
- •informed consent or to
- •comply with the protocol
- •20. Any condition requiring continuous systemic treatment with either
- •corticosteroids (>10 mg daily
- •prednisone equivalents) or other immunosuppressive medications within 4 weeks
- •prior to first dose
- •of study treatment. Inhaled or topical steroids and physiological replacement
- 另有 12 项未显示
研究者
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