EUCTR2014-004572-34-PL进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 plus Nab-paclitaxel and Gemcitabine versus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer - A Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
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
- •Inclusion Criteria for All Patients
- •a) Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not eligible.
- •b) Patient must have received no prior surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease. Prior systemic treatment in the adjuvant or neoadjuvant setting (either alone and/or as a radiosensitizer) is only allowed if administered = 6 months prior to enrollment onto this study. Prior radiotherapy to metastatic lesions will be considered on a case by case basis after discussion with the sponsor.
- •c) Candidates to receive nab-paclitaxel and gemcitabine per the label of the combination
- •d) = 18 years of age
- •e) Must provide informed consent, or have a legal representative able and willing to do so in accordance with the local regulatory definitions and requirements, in cases where the patient does not have the capacity to sign the informed consent form.
- •Additional Inclusion Criteria for Part 1 and the Interventional Group:
- •a) High serum levels of free IGF-1
- •b) ECOG Performance Status (PS) of 0,1
- •c) Adequate bone marrow reserve as evidenced by:
- •ANC > 1,500/µl
- •Platelet count > 100,000/µl
- •Hemoglobin > 9 g/dL
- •d) Adequate renal function as evidenced by a serum/plasma creatinine < 1.5 x ULN
- •e) Serum/plasma total bilirubin within normal range for the institution
- •f) Serum/plasma albumin levels >3 g/dL
- •g) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN (=5
- •x ULN is acceptable if liver metastases are present)
- •h) Significant or symptomatic amounts of ascites should be drained, and pain symptoms should be stable prior to Day 1
- •i) Women of childbearing potential must be willing to abstain from sexual intercourse or to use a highly effective form of contraception during the study and for 90 days following the last dose of study drugs. Fertile men and their partners must be willing to abstain from sexual intercourse or to use a highly effective form of contraception during the study and for 6 months following the last dose of study drug(s), in accordance with the label requirements for nab-paclitaxel and gemcitabine. Male patients should seek advice regarding cryoconservation of sperm prior to treatment with nab-paclitaxel / gemcitabine because of the possibility of infertility.
- •Additional Inclusion Criteria for the Interventional Group Only:
- •a) Available recent tumor specimen, collected after all prior adjuvant or neoadjuvant treatment or at the time of initial metastatic
- •diagnosis, submitted to the central lab OR
- •b) Disease must be amenable to biopsy, and patient must be appropriate candidate for a biopsy per the Investigator’s
- •? b.1. Patient must be willing to undergo the pre-treatment biopsy
- •? b.2. Coagulation profile (INR and aPTT) within the institutional guidelines prior to the pre-treatment biopsy
- •Measureable disease in accordance with RECIST v1.1
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •a) Pregnant or lactating
- •b) Patients who only present with localized disease, including local/locoregional relapse
- •c) Presence of an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing, which in the investigator’s opinion might compromise the patient’s participation in the trial or affect the study outcome. If the fever and active infection have resolved prior to randomization, the patient will be eligible. At the discretion of the investigator, patients with tumor fever may be enrolled
- •d) Patients with CNS malignancies (primary or metastatic) are excluded.
- •e) History of any malignancy in the last 3 years. Subjects with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Subjects with other malignancies are eligible if they have been continuously disease free for at least 3 years.
- •f) Known hypersensitivity to the components of MM-141, an anti-ErbB3 monoclonal antibody, an anti-IGF-1R monoclonal antibody, or who have had Grade 3-4 hypersensitivity reactions to human monoclonal antibodies
- •g) Prior treatment with any kind of IGF-1R or ErbB3 target agents at any time prior to enrolling into this study
- •h) Known history of allergy or hypersensitivity to nab-paclitaxel, gemcitabine or their excipients
- •i) Known hypersensitivity against polysorbate (Tween) 80 or arginine
- •j) Clinically significant cardiac disease, including: NYHA Class III or IV congestive heart failure, unstable angina, acute myocardial infarction within six months of planned first dose, arrhythmia requiring therapy (including torsades de pointes, with the exception of extra systoles, minor conduction abnormalities, or controlled and well treated chronic atrial fibrillation)
- •k) Any episode of uncontrolled bleeding within the last 4 months.
- •l) Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
- •m) History of connective tissue disorders (e.g. lupus, scleroderma, arteritis nodosa)
- •n) History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis
- •o) History of peripheral artery disease (e.g. claudication, Leo Buerger’s disease)
- •p) Use of strong CYP3A4 and/or CYP2C8 inhibitors or inducers
- •q) Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator
- •r) Patients housed in an institution following a regulatory or judicial order, in accordance with the local regulatory definitions and requirements
- •s) Patients who have previously received gemcitabine in combination with nab-paclitaxel.
研究者
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