NCT02103062已完成2 期
A SINGLE ARM PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF Nab®-PACLITAXEL, IN SUBJECTS WITH PREVIOUSLY TREATED METASTATIC COLORECTAL CANCER
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Progression Free Survival (PFS) Rate as Measured at Week 8
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Abraxane (nab-paclitaxel) in subjects with previously treated metastatic colorectal cancer. Subjects will be placed into two separate cohorts based on their RAS mutation status.
详细描述
ABI-007-COLO-001 is a Phase 2, single arm, open label, multicenter study to evaluate the efficacy and safety of Abraxane (nab-paclitaxel) given on days 1, 8 and 15 of a 28 day cycle in subjects with previously treated metastatic colorectal cancer. Subjects will be enrolled into cohorts by RAS mutation status (wildtype or mutated). Stage 1 in a given cohort will enroll 15 subjects in the Intention to Treat population and if more than 8 subjects have Progression Free Survival at the 8 week assessment, then Stage 2 will open in the respective cohort. Stage 2 will enroll an additional 28 subjects for a total of 43 subjects in each cohort. The study will be positive if more than 26 subjects with Progression Free Survival at the 8 week assessment are observed in 43 subjects per cohort. Interim analysis after Stage 1 did not meet protocol defined criteria to proceed to Stage 2. Patients currently enrolled will be followed for Progression Free Survival and until 28 days after last dose, secondary endpoints including overall survival will not be followed
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years old at the time of signing the Informed Consent Form
- •Subject has histological or cytological diagnosis of adenocarcinoma of the colon or rectum, with evidence of metastasis
- •Subject has a known KRAS mutation status (mutated or wild-type). NRAS mutation status may be unknown.
- •Subject has documented disease progression ≤ 2 months after the last administration of the last standard therapy. a. Subjects treated with oxaliplatin in the adjuvant setting, should have progressed during or within 6 months of completion of adjuvant therapy
- •Subject has either received prior treatment or was not a candidate for prior treatment, with fluoropyrimidine, oxaliplatin, irinotecan and an anti-VEGF therapy (e.g. bevacizumab or ziv-aflibercept); and if RAS wild-type tumors, an anti-EGFR therapy (e.g. cetuximab or panitumumab).
- •Subject has Eastern Cooperative Oncology Group performance status 0 or 1
- •Subject has radiographically-documented measurable disease, as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria
- •Subject has adequate organ functions, evidenced by the following: a. Aspartate Aminotransferase (SGOT), Alanine Transaminase (SGPT) ≤ 2.5 × upper limit of normal range, or < 5 x upper limit of normal range if liver metastasis present b. Total bilirubin ≤ 1.5 × upper limit of normal range c. Creatinine ≤ 1.5 × upper limit of normal range
- •Subject has adequate bone marrow function, evidenced by the following: a. Absolute neutrophil count ≥ 1.5 × 109 cells/millimeters3 b. Platelets ≥ 100 × 109 cells/millimeters3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample) c. Hemoglobin ≥ 9 grams/decilitre (transfusion is permitted to fulfill this criterion)
- •Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must: a. Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting Investigational Product therapy (including dose interruptions), and for 3 months following the last dose of Investigational Product; and b. Have a negative serum pregnancy test (β -human Chorionic Gonadotrophin) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Note: Periodic abstinence (e.g, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •Male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following Investigational Product discontinuation, even if he has undergone a successful vasectomy.
- •Subject must understand and voluntarily sign an Informed Consent Form prior to any study related assessments or procedures being conducted.
- •Subject must be able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Subject has current or a history of brain metastasis. In subjects who are symptomatic, a brain scan is required to exclude metastasis.
- •Subject has ≥ National Cancer Institute Common Terminology Criteria for Adverse Events grade 2 peripheral neuropathy at screening
- •Subject has had prior treatment with regorafenib
- •Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting Investigational Product, and/or from whom ≥ 30% of the bone marrow was irradiated. Radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- •Subject has had major surgery within 14 days prior to starting Investigational Product or has not recovered from postoperative complications
- •Subject has not recovered from the acute toxic effects of prior anticancer therapy, radiation or major /significant trauma
- •Subject has a history of allergy or hypersensitivity to nab-paclitaxel or any of the excipients
- •Subject has a known history of the following within 6 months prior to enrollment (the decision to include the subject in the study): a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or Electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
- •Subject has a known infection with hepatitis B or C, or history of human immunodeficiency virus infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- •Subject has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- •Subject has any other malignancy within 5 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or non-melanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment)
- •Subject has a history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
- •Subject has a history of interstitial lung disease , history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
- •Subject has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate subject participation in the clinical study (e.g. chronic pancreatitis, chronic active hepatitis, etc.)
- •Subject is enrolled in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
- •Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- •Subject has any condition that confounds the ability to interpret data from the study
- •Subject is unwilling or unable to comply with study procedures
- •Subject is a pregnant or nursing female
研究组 & 干预措施
Abraxane (nab®paclitaxel)
Experimental
Abraxane (nab®paclitaxel) 125 milligrams per meter squared on days 1, 8 and 15 of a 28 day cycle
干预措施: ABI-007 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Rate as Measured at Week 8
时间窗: At week 8 assessment period; up to 56 days
PFS rate was measured by Investigator Assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 from the start of study treatment to disease progression or death from any cause, whichever occurred first.
次要结局
- Percentage of Participants With Stable Disease for ≥ 8 Weeks, or Complete or Partial Response According to RECIST Version 1.1; Disease Control Rate (DCR)(At week 8 and later; up to day 241)
- Overall Survival(Up to 241 days)
- Overall Response Rate (ORR)(Up to 241 days)
- Duration of Response (DOR)(Up to 241 days)
- Number of Participants With Adverse Events(Time of the first dose of study treatment to 28 days after the last dose of study drug; maximum treatment duration was 24 weeks)
研究者
研究点 (6)
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