EUCTR2016-001099-31-IT进行中（未招募）1 期
A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer - A study of nab-paclitaxel and gemcitabine with or without olaratumab for treatment of pancreatic can
ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 个研究点目标入组 186 人开始时间: 2021年2月10日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 186
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
- •[1] have histological or cytological diagnosis of adenocarcinoma of the exocrine
- •pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent and be patients for whom nab-paclitaxel-gemcitabine therapy is
- •considered by the investigator to be an appropriate treatment. Patients
- •previous radical surgery for pancreatic cancer are eligible after progression is
- •documented.
- •[2] if present, clinically significant or symptomatic amounts of ascites
- •drained prior to Day 1
- •[3] have sufficient available material from an archived formalin-fixed
- •paraffinembedded (FFPE) tumor tissue for biomarker-related studies. If such tissue is
- •not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed in the Phase 2 portion of the study.
- •[4] The patient has measurable or nonmeasurable but evaluable disease as defined
- •by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1,
- •Eisenhauer et al. 2009). Tumors within a previously irradiated field will
- •be designated as nontarget lesions unless progression is documented or a
- •biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy.
- •[5] have had no prior systemic treatment for metastatic disease. Prior adjuvant or
- •neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed, if completed =3 months prior to enrollment and no lingering toxicities are present.
- •[6] prior radiation therapy for treatment of cancer is allowed to <25% of the bone
- •marrow (Cristy and Eckerman 1987). Patients must have recovered from the acute toxic effects of their treatment prior to study enrollment.
- •[7] have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology
- •Group (ECOG) scale (Oken et al. 1982)
- •[8] Patients must have discontinued from previous treatments for cancer (radiotherapy/major surgery, excluding biopsy) 4 weeks prior to study
- •treatment.[9]Have adequate organ function[10] are at least 18 years old at the time of screening/randomization
- •[11] If male, the patient is sterile (including vasectomy) or agrees to use an effective method of birth control. Refer to Appendix 1 for definitions of
- •effective method
- •[12] If female:o is not of childbearing potential due to surgical sterilization confirmed
- •by medical history (at least 6 weeks post-surgical bilateral oophorectomy with or
- •without hysterectomy or tubal ligation) or menopause
- •o is of childbearing potential, has a negative serum or urine pregnancy
- •within 72 hours prior to the first dose of study treatment, agrees to use a highly effective method of birth control during the study and for up to
- •120 days following the last dose of the study treatment, and is not breastfeeding. If the urine test is positive or cannot be confirmed as
- •negative, a serum pregnancy test will be required. Refer to Appendix 1 for definitionsof effective method of contraception and highly effective method of contraception.
- •[13] have given written informed consent/assent prior to any studyspecific procedures
- •[14] has a life expectancy of at least 3 months in the opinion of the investigators
- •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 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •[15] have received first line treatment for metastatic pancreatic cancer.
- •[16] have received prior treatment with nab-paclitaxel
- •[17] have a serious concomitant systemic disorder (for example, active infection
- •including human immunodeficiency virus, or cardiac disease) or other
- •condition that, in the opinion of the investigator, would compromise the
- •patient’s ability to adhere to the protocol
- •[18] have known central nervous system (CNS) malignancy or metastasis
- •(screening not required)
- •[19] have current hematologic malignancies, acute or chronic leukemia
- •[20] have participated within the last 30 days in a clinical trial involving an
- •investigational product. If the previous investigational product has a long
- •half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
- •[21] are women with a positive pregnancy test or who are lactating
- •[22] have endocrine pancreatic tumors or ampullary cancer
- •[23] are currently enrolled in a clinical trial involving an investigational product or
- •any other type of medical research judged not to be scientifically or medically
- •compatible with this study
- •[24] have known additional malignancy that is progressing or riquired active treatments within the past 1 year Note: Participants with basal cell carcinoma of the skin, squamous cell
- •carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma,cervical cancer in situ)
- •[25] have known allergy to nab-paclitaxel, gemcitabine, or Olaratumab (levels of IgE antibodies against a-gal that are above the upper limit of normal) or any ingredient of olaratumab, nab-paclitaxel, or gemcitabine formulations.
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