| General information |
| Database: | DB00136 |
| Objective: | A multicenter, randomized, phase 1b/2 trial of the oral cMet inhibitor MSC2156119J as firstline monotherapy versus sorafenib in Asian patients with METpositive (MET+) advanced hepatocellular carcinoma (hepatocellular carcinoma) and ChildPugh Class A liver function. MSC2156119J showed promising antitumor activity and a recommendedphase 2 dose was determined (RP2D; 500 mg/d). |
| Authors: | Shukui Qin, et al |
| Title: | A multicenter, randomized, phase 1b/2 trial of the oral cMet inhibitor MSC2156119J as firstline monotherapy versus sorafenib in Asian patients with METpositive (MET+) advanced hepatocellular carcinoma (hepatocellular carcinoma) and ChildPugh Class A liver function. |
| Journal: | J Clin Oncol |
| Year: | 2014 ASCO Annual Meeting |
| PMID: | http://meetinglibrary.asco.org/content/129153144 |
| Trial Design |
| Clinical Trial Id: | NCT01988493. |
| Agent: | MSC2156119J
|
| Target: | Hepatocyte growth factor receptor
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | METpositive advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase Ib/II, multicenter, openlabel trial |
| Key Patients Feature: | Adults with confirmed, advanced hepatocellular carcinoma of BCLC Stage C, ChildPugh Class A liver function, life expectancy >3 mo, and ECOG status 0-2 (Phase II only: MET+, defined as moderate or strong protein overexpression determined by immunohistochemistry, eligible for sorafenib treatment, and measurable disease according to RECIST v1.1) are recruited in mainland China, South Korea, Taiwan, and other Asian countries. |
| Biomarker: | METpositive |
| Biomark Analysis: | NA |
| Control Group Info: | sorafenib |
| Treatment Info: | Up to 18 pts are planned for the phase Ib part (3+3 design; 300 or 500 mg MSC2156119J p.o./d; 21d cycle). In the phase II part, 140 pts are planned to be randomized 1:1 to receive either MSC2156119J at the RP2D p.o./d or 400 mg sorafenib p.o./twice daily (21d cycle). |
| Primary End Point: | the RP2D, efficacy:time to progression (TTP) |
| Secondary End Point: | pharmacokinetics, preliminary antitumor activity, safety, tolerability, and antitumor activity (Phase II: progression free survival and TTP, overall survival, time to symptomatic progression, objective response, and disease control). |
| Patients Number: | 158 |
| Trial Results |
| DLT_MTD: | pending |
| Objective Response Rate: | pending |
| Disease Control Rate: | pending |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | pending |
| Median OS A vs. C: | pending |
| Adverse Event(agent arm): | pending |
| Conclusions: | pending |