EUCTR2010-019564-37-DE进行中（未招募）不适用
A Double-blind Placebo-controlled Randomized Multicenter Phase II Trial of Skin Toxicity Treatment in Subjects with Metastatic Colorectal Carcinoma Receiving Panitumumab - SKIP
GMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH0 个研究点目标入组 84 人开始时间: 2011年1月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
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. Patients with wild-type KRAS metastatic colorectal cancer (mCRC) who are planned to receive treatment with panitumumab
- •-> In first-line in combination with FOLFOX or
- •-> In second-line in combination with FOLFIRI if they have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) or
- •As monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens
- •and who did not receive any prior treatment with epidermal growth factor receptor (EGFR) antibody
- •2. Man or woman 18 years of age or older
- •3. Signed and dated informed consent before the start of specific protocol procedures
- •4. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2
- •5. Bilirubin = 1.5 x ULN, SGOT/SGPT = 2.5 x ULN,
- •AP = 3 x ULN if no evidence of liver metastases
- •Bilirubin = 3 x ULN, SGOT/SGPT = 5 x ULN,
- •AP = 5 x ULN if evidence of liver metastases
- •6. Women of child-bearing potential have to use adaequate highly effective methods of contraception. Since doxycyline may reduce efficacy of hormonal contraceptives, women of child-bearing potential have to use double-barrier methods within 4 weeks before first intake of study medication, during study participation and at least 6 weeks after last intake of study medication even if using hormonal contraceptives Women are considered to be of child-bearing potential unless they are = 50 years old and for more than 2 years amenorrhoic or unless they are surgically sterile
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Absence of any of the above-listed inclusion criteria
- •2. Unknown KRAS or mutated KRAS of mCRC
- •3. Any serious medical condition or psychiatric illness that would interfere with the patient’s ability to sign the informed consent form.
- •4. Allergic reaction to one of the medications to be used
- •5. Subject allergic to panitumumab or any components of the panitumumab formulation or treatment regimen
- •6. Prior treatment with EGFR antibody
- •7. CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampicin, rifabutin, and St. John’s Wort) = 2 weeks before randomization (itraconazole should be used with caution)
- •8. Subjects with hypersensitivity to doxycycline, other tetracyclines, or ingredients of doxycycline capsules
- •9. Systemic treatment with antibiotics which was completed less than 7 days prior to randomization
- •10. Pregnant and/or breast-feeding women
- •11. Active participation in other clinical studies in the previous 4 weeks
- •12. Serious liver function disorders
- •13. History of, or evidence of, interstitial pneumonitis or pulmonary fibrosis
- •14. Person who has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
研究者
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