EUCTR2009-011101-16-GB进行中（未招募）1 期
Dose-Escalation Study to Evaluate the Safety and Tolerability of SCH 717454 in Combination with Different Treatment Regimens in Subjects with Advanced Solid Tumors (Phase 1b/2; Protocol No. P04722) - N/A
Schering-Plough Research Institute, A Division of Schering Corporation0 个研究点目标入组 250 人开始时间: 2009年9月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
入选标准
- •1. Subject must be =18 years of age. A subject may be of either sex & of any race/ethnicity
- •2. Part 1: Subject must have a histologically or cytologically confirmed advanced malignant solid tumor
- •Part 2: Subject must have a histologically or cytologically confirmed, with measurable disease (as defined by RECIST), advanced, malignant solid tumor type as specified below for which treatment in the given regimen is appropriate:
- •Regimen A: Colorectal Adenocarcinoma
- •Regimen B: Non-small Cell Lung Cancer
- •Regimen C: Gastric Adenocarcinoma
- •Regimen D: Her2+ Breast Cancer
- •Regimen E: Renal Cell Cancer
- •Regimen F: Pancreatic Adenocarcinoma
- •3. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of =2
- •4. Subject must have adequate organ function within 3 wks prior to 1st study drug administration as evidenced by:
- •a) Absolute neutrophil count =1.5 x 10 to the 9th power /L
- •b) Hemoglobin =90 g/L (=80 g/L for subjects w/renal cell carcinoma)
- •c) Platelet count =100 x 10 to the 9th power/L
- •d) Serum creatinine =1.5 x upper limit of normal (ULN) or a calculated creatinine clearance >60 mL/min
- •e) Total bilirubin <1.5 x ULN, except for subjects w/Gilbert’s disease,
- •f) Alkaline phosphatase, aspartate aminotransferase (AST)/serum glutamic-oxalacetic transaminase (SGOT) & alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <3 x ULN, or, in the presence of documented liver metastases, =5 x ULN
- •5.(Only subjects assigned to receive Epirubicin [Regimen C]): Each subject must have a left ventricular ejection fraction (LVEF) of =50% by Multi Gated Acquisition Scan (MUGA) or echocardiogram
- •6. Subject must be able to adhere to dose & visit schedules
- •7. Female subject (& male subject whose female partner also provides written informed consent to provide information regarding pregnancy) of childbearing potential, must agree to use a medically accepted method of contraception, or abstain from sexual intercourse, during Screening, while receiving protocol-specified medication, & for 2 months after stopping the medication. Females who are not currently sexually active must also consent to use one of these accepted methods of contraception should they become sexually active while participating in the study. Medically accepted methods of contraception include: systemic hormonal contraceptive & surgical sterilization (eg, hysterectomy or tubal ligation). Condoms (male & female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, & medically prescribed intrauterine devices may be acceptable according to local regulations
- •Note: Vasectomy of the partner is not considered sufficient contraception, & one of the methods listed above must be used. A male subject must agree to use a medically accepted method of contraception (see above) or abstain from sexual intercourse during the trial & for 2 months after stopping the medication. Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period
- •8. To participate in the pharmacogenomic analysis, the subject must be
排除标准
- •1. Subject must not have known treated or untreated leptomeningeal metastasis or a metastatic central nervous system lesion. Subjects w/a clinical history of central nervous system metastases or cord compression may be eligible, provided they have been definitively treated & are clinically stable, after discussion w/sponsor
- •2. Subject must not have a history (w/in 5 yrs prior to first study drug administration) of another malignancy excluding adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of the skin or carcinoma in situ of the cervix or other adequately treated malignancy for which the subject has been disease free for =5 yrs)
- •3. Subject must not have received any treatment listed in the Table stated in Protocol syopsis more recently than the indicated washout period prior to Day 1 Cycle 1
- •4. A subject must not continue to receive any treatment listed in the Table stated in Protocol synopsis during the current trial
- •5. Subject must not have received prior therapy w/any anti-IGF-1R monoclonal antibody
- •6. Subject must not have received radiation therapy w/in 2 wk prior to 1st study drug administration
- •7. Subject must not have received radiation therapy to >25% of his/her total bone marrow during his/her lifetime
- •8. Subject must not have undergone major surgery w/in 3 weeks prior to first study drug administration
- •9. Subject must not have known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy. If the investigator is suspicious that a subject has one of these diseases, they should test to confirm prior to Day 1 Cycle 1
- •10.Subject must not have known active hepatitis B or C. If the investigator is suspicious that a subject has one of these diseases, they should test to confirm prior to Day 1 Cycle 1
- •11. Subject must not have any serious or uncontrolled infection
- •12. Subject must not have uncontrolled diabetes mellitus, defined as a hemoglobin A1C of =7.5% at Screening in a subject w/known diabetes mellitus (subjects w/elevated glucose values at Screening should be evaluated for diabetes mellitus)
- •13. Subject must not have had any of the following w/in 6 months prior to 1st study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder
- •14. Subject must not have persistent, unresolved CTC for AEs (CTCAE) Grade =2 drug-related toxicity (except alopecia, erectile impotence, tinnitus, hot flashes, & loss of libido) associated w/previous treatment (inclusion of subjects w/persistent neuropathy or hearing loss Grade =2 due to previous treatment require discussion with the sponsor)
- •15. Subject must not be participating in any other clinical study w/a potentially therapeutic agent or must not have received another investigational product w/in 21 days prior to Day 1 Cycle 1
- •16. Subject must not have any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participati
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