EUCTR2015-002541-63-BE进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 241
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
- Female
入选标准
- •1. Able to give written informed consent and to comply with the protocol
- •2.1 Metastasized 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 received first line chemotherapy with weekly paclitaxel
- •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 present
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 121
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 treatment
- •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 study)
- •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 cervix
- •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 doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
- •21. Past history of severe allergic episodes and/ or Quincke’s oedema
- •22. Alcohol or substance abuse disorder
- •23. Known hypersensitivity to any of the components of the study agents
- •24.1 Participation in an interventional clinical study within 4 weeks prior to first dose of study treatment, with intervention not covered by exclusion criterion 6.2
- •25. Unwilling or unable to follow protocol requirements
- •26. In the clinical judgment of the Investigator, the patient is unsuitable for participation in this study
- •27. Persons with any kind of dependency on the Investigator or employed by the sponsor or Investigator
- •28. Persons held in an institution by legal or official order
- •29. Patients with prior organ or stem cell transplantation
- •30. Patients having received a live, attenuated vaccin
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