EUCTR2012-000317-36-DK进行中（未招募）不适用
A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab(MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecanfor Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2Levels - Phase IIa trial of MK0646 Tx in combo w/ Irinotecan vs Cetuximab and Irinotecan for mRC patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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.Patient has metastatic colorectal cancer whose primary tumor originated from the rectum.
- •2.Patient has archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies. Archival specimens must be tumor block, surgical specimens or core needle biopsy specimens. (Fine needle biopsies are not adequate.) Please refer to Procedures Manual for details on sample collection and processing.
- •3.Patient's tumor is KRAS wild type as determined by testing at the program central laboratory during the screening period as outlined in the dalotuzumab PN025 Assay Charter.
- •4. Patient's whose tumor over-expresses IGF-1, determined by the central laboratory during the screening. The IGF-1 level determination is outlined in the dalotuzumab PN025 Assay Charter.
- •5.Patient has at least one measurable lesion greater than or equal to 15 mm. (Refer to the Investigators’ Imaging Operations Manual [within the Procedures Manual] for detailed information].
- •6.Patient’s disease has progressed after treatment with both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy. Note: Failing oxaliplatin would include failure due to toxicities. Note: Failing irinotecan requires a minimum previous exposure to irinotecan of two cycles.
- •7.Patient has performance status 0-1 on the ECOG Performance Scale.
- •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 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patient has a mutant KRAS (mutKRAS) metastatic rectal cancer determined by testing at the program central laboratory during the screening period.
- •2.Patient has a high IGF-2 expressing metastatic rectal cancer determined by testing at the program central laboratory during the screening.
- •3.Patient is a known diabetic patient who is poorly controlled (HbA1c >8%).
- •4.Patient who has had chemotherapy or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery.
- •5.Patient who has had radiotherapy within two weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain.
- •6.Patient is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study.
- •7.Patient could not complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (>4 months exposure).
研究者
相似试验
进行中（未招募）
不适用
Phase IIa trial of MK0646 Tx in combo w/ Irinotecan vs Cetuximab and Irinotecan for mRC patientsEUCTR2012-000317-36-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.70
进行中（未招募）
不适用
Phase IIa trial of MK0646 Tx in combo w/ Irinotecan vs Cetuximab and Irinotecan for mRC patientsrectal cancerEUCTR2012-000317-36-SEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.70
进行中（未招募）
不适用
Phase IIa trial of MK0646 Tx in combo w/ Irinotecan vs Cetuximab and Irinotecan for mRC patientsrectal cancerEUCTR2012-000317-36-GBMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.70
进行中（未招募）
不适用
Phase IIa trial of MK0646 Tx in combo w/ Irinotecan vs Cetuximab and Irinotecan for mRC patientsrectal cancerEUCTR2012-000317-36-BEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.70
尚未招募
不适用
A Study to Test MK-0646 (Dalotuzumab) Treatment in Combination with Irinotecan Compared to Cetuximab and Irinotecan Treatment in Patients with Metastatic Rectal CancersNeoplasmsKCT0000497MSD Korea70