An Open-Label, Three-Part, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212, BRAF Inhibitor GSK2118436 and the anti-EGFR Antibody Panitumumab in Combination in Subjects with BRAF-mutation V600E Positive Colorectal Cancer. - MEK116833

ovartis0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•* BRAF V600E mutation positive colorectal cancer (CRC), as determined by local genetic testing.
•* Provision of archival tissue; if archival tissue is not available or found to not contain tumor tissue, a fresh biopsy is required.
•* Willingness to follow contraception requirements.
•* ECOG 0 or 1.
•* LVEF *LLN, or 50% if not defined by institution.
•* Organ function as noted in Table 17:
•* ANC *1.2 × 109/L
•* Hemoglobin *9 g/dL or 5.6 mmol/L
•* Platelets *75 × 109/L
•* PT/INR and PTT *1.5 x ULN
•* Mg++ * LLN
•* Albumin *2.5 g/dL or 25 g/L
•* Total bilirubin *1.5 x ULN
•* Creatinine * 1.5 ULN or Calculated creatinine clearance * 50 mL/min

•* Prior malignancy, other than colorectal cancer.
•* Prior exposure to BRAF or MEK inhibitors.
•* Part 2 ONLY* prior exposure to EGFR antibodies or inhibitors.
•* KRAS mutation positive.
•* Received an investigational or approved anti-cancer drug within 4 weeks, or within 5 half-lives (whichever is shorter) of the first dose of study drug(s). At least 14 days must have passed between the last dose of prior investigational agent and the first dose of study drug(s).
•* RVO, CSR or predisposing factors to RVO or CSR. Ophthalmic exam is required at screening, and intraocular pressure must not exceed 21mm Hg.
•* Brain mets must be stable *90 days and treated with surgery or stereotactic radiosurgery.

发起方