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临床试验/EUCTR2009-017477-38-DE
EUCTR2009-017477-38-DE进行中（未招募）不适用

An Open-Label, Dose-Escalation, Phase IB/ II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor GSK1120212 in Combination with Oral Everolimus in Subjects with Solid Tumors

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 100 人开始时间: 2010年3月18日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
100
研究概览入排标准研究者记录与标识符相似试验

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

  • •A subject will be eligible for inclusion in this study only if all of the following criteria
  • •1. Capable of giving written informed consent, which includes compliance with the
  • •requirements and restrictions listed in the consent form.
  • •2. Age 18 years old or older and able to swallow oral medication.
  • •3. Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology
  • •(ECOG) scale for Phase IB/Dose Escalation Cohort. Subjects with ECOG PS of 2
  • •can be enrolled for Phase IB/Expansion Cohort and Phase II.
  • •4. Tumor Type criteria:
  • •Phase IB/Dose Escalation Cohort
  • •o Histologically or cytologically confirmed diagnosis of solid tumor malignancy:
  • •That is relapsed/refractory
  • •OR is potentially responsive to everolimus
  • •OR for which there is no standard or curative therapy
  • •OR for subjects who refuse standard therapy
  • •Phase IB/Expansion Cohort
  • •o Pancreatic cancer: Histologically or cytologically confirmed diagnosis of metastatic pancreatic cancer. Subjects with locally advanced surgically unresectable disease are also eligible.
  • •o Measurable disease by RECIST 1.1.
  • •o KRAS- mutant NSCLC: Histologically or cytologically confirmed diagnosis of metastatic NSCLC
  • •o Measurable disease by RECIST 1.1 [Eisenhauer, 2009].
  • •5. Fasting glucose < 126mg/dL
  • •6. Male subjects must agree to use one of the contraception methods listed in
  • •Section 7.1.2. This criterion must be followed from the time of the first dose of
  • •study medication until 4 weeks after the last dose of study medication. However, the
  • •Sponsor advises that contraception be used for a total of 16 weeks following the last
  • •dose (based on the lifecycle of sperm).
  • •7. A female subject is eligible to participate if she is of:
  • •Non-childbearing potential defined as pre-menopausal females with a
  • •documented tubal ligation or hysterectomy; or postmenopausal defined as 12
  • •months of spontaneous amenorrhea [in questionable cases a blood sample with
  • •simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and estradiol <
  • •40 pg/mL (<140 pmol/L) is confirmatory]. Females on hormone replacement
  • •therapy (HRT) and whose menopausal status is in doubt will be required to use
  • •one of the contraception methods in Section 7.1.1 if they wish to continue their
  • •HRT during the study. Otherwise, they must discontinue HRT to allow
  • •confirmation of post-menopausal status prior to study enrollment. For most
  • •forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy
  • •and the blood draw; this interval depends on the type and dosage of HRT.
  • •Following confirmation of their post-menopausal status, they can resume use of
  • •HRT during the study without use of a contraceptive method.
  • •Child-bearing potential and agrees to use one of the contraception methods listed
  • •in Section 7.1 for an appropriate period of time (as determined by the product
  • •label or investigator) prior to the start of dosing to sufficiently minimize the risk
  • •of pregnancy at that point. Female subjects must agree to use contraception until
  • •4 weeks after the last dose of study medication.
  • •Note: Oral contraceptives are not reliable due to potential drug-drug interaction
  • •8. Calcium phosphate product = 4.0 mmol2/L2 (50 mg2/dL2)
  • •9. Adequate organ system function as defined in Table 10 of the protocol
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • 另有 3 项未显示

排除标准

  • •A subject will not be eligible for inclusion in this study if any of the following criteria
  • •1. Malignancies related to HIV or solid organ transplant.
  • •2. Primary malignant brain tumors.
  • •3. Chemotherapy, radiotherapy, or immunotherapy within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of GSK1120212. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity are permitted with approval of a GSK Medical Monitor if dosing of that agent is terminated at least 14 days prior to the first dose of GSK1120212.
  • •4. Use of an investigational anti-cancer drug within 28 days or 5 half-lives, whichever
  • •is shorter preceding the first dose of GSK1120212 – as long as a minimum of 14
  • •days has passed between the last dose of the prior investigational anti-cancer drug
  • •and the first dose of GSK1120212.
  • •5. Previous treatment with an mTOR inhibitor unless approved by GSK Medical
  • •6. Previous treatment with GSK1120212.
  • •7. History of sensitivity to any of the study medications, or components thereof or a
  • •history of drug or other allergy that, in the opinion of the investigator or GSK
  • •Medical Monitor, contraindicates their participation.
  • •8. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
  • •chemically related to the study drug, DMSO, or excipients (see GSK1120212
  • •Investigator Brochure [GlaxoSmithKline Document Number RM2007/00107/00].
  • •(To date there are no known FDA approved drugs chemically related to
  • •GSK1120212).
  • •9. Use of a prohibited medication (as defined in Section 8.2).
  • •10. Current use of anticoagulants (e.g. warfarin, heparin) at therapeutic levels within
  • •seven days prior to the first dose of GSK1120212. Low dose (prophylactic) low
  • •molecular weight heparin (LMWH) is permitted provided that subject’s PT and PTT
  • •meet entry criteria. Subjects required therapeutic levels of LMWH must receive
  • •approval from GSK Medical Monitor and monitored appropriately as clinically
  • •11. Gastrointestinal disease predicted to interfere with absorption of an oral drug,
  • •systemic disease, major surgery, or social/psychological issues that in the opinion of
  • •investigators would jeopardize compliance with protocol.
  • •12. History of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
  • •13. Predisposing factors to RVO including uncontrolled hypertension, uncontrolled
  • •diabetes, uncontrolled hyperlipidemia, and coagulopathy.
  • •14. Visible retinal pathology as assessed by ophthalmologic exam that is considered a
  • •risk factor for RVO or CSR.
  • •15. Intraocular pressure > 21mm Hg as measured by tonography.
  • •16. Glaucoma diagnosed within 1 month prior to study Day 1.
  • •17. Symptomatic or untreated leptomeningeal or brain metastases or spinal cord
  • •compression. Subjects previously treated for these conditions that are asymptomatic
  • •and off corticosteroids for at least two weeks are permitted. Subjects are not
  • •permitted to receive enzyme inducing anti-epileptic drugs (EIAEDs).
  • •18. Unresolved toxicity greater than common terminology criteria for adverse events
  • •(CTCAE) grade 1 from previous anti-cancer therapy except alopecia (if applicable)
  • •unless agreed to by a GSK Medical Monitor and the Investigator.
  • •19. History of acute coronary syndromes (including unstable angina), coronary
  • •angioplasty, or stenting within the past 24 weeks.
  • •20. QTc interval = 480 msecs.
  • •21. Class II, III, or IV heart failure as defined by the New York Heart Association
  • •(NYHA) functional

研究者

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