Not provided
Not provided
Not provided
Not provided
All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction adenocarcinoma (GEJ).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilotumumab | Experimental | Rilotumumab plus Cisplatin and Capecitabine (CX). |
|
| Placebo | Placebo Comparator | Rilotumumab-placebo plus Cisplatin and Capecitabine (CX). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilotumumab | Drug | Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/SF/MET-driven activities in cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | To determine if the treatment of rilotumumab in combination with CX significantly improves progression-free survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression. | 4 years |
| Overall Survival | To determine if the treatment of rilotumumab in combination with CX significantly improves overall survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| TTP | Time to Progression (TTP) | 4 years |
| ORR | Objective Response Rate | 4 years |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo |
|
| Cisplatin | Drug | A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death) |
|
|
| Capecitabine | Drug | A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue. |
|
|
| DCR | Disease Control Rate | 4 years |
| TTR | Time to Response | 4 years |
| Incidence of subject adverse events, laboratory abnormalities and immunogenicity | Adverse events and laboratory abnormalities are reported by Common Terminology Criteria for Adverse Events (CTCAE) (v3.0) | 4 years |
| Chiba |
| Chiba |
| 260-8717 |
| Japan |
| Research Site | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Research Site | Matsuyama | Ehime | 791-0280 | Japan |
| Research Site | Fukuoka | Fukuoka | 811-1395 | Japan |
| Research Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Research Site | Akashi-shi | Hyōgo | 673-8558 | Japan |
| Research Site | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
| Research Site | Osaka | Osaka | 537-8511 | Japan |
| Research Site | Osaka | Osaka | 540-0006 | Japan |
| Research Site | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Research Site | Suita-shi | Osaka | 565-0871 | Japan |
| Research Site | Takatsuki-shi | Osaka | 569-8686 | Japan |
| Research Site | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Research Site | Suntou-gun | Shizuoka | 411-8777 | Japan |
| Research Site | Utsunomiya | Tochigi | 320-0834 | Japan |
| Research Site | Bunkyo-ku | Tokyo | 113-8677 | Japan |
| Research Site | Goyang-si, Gyeonggi-do | 410-769 | South Korea |
| Research Site | Hwasun | 519-763 | South Korea |
| Research Site | Seoul | 110-744 | South Korea |
| Research Site | Seoul | 120-752 | South Korea |
| Research Site | Seoul | 135-710 | South Korea |
| Research Site | Seoul | 136-705 | South Korea |
| Research Site | Seoul | 137-701 | South Korea |
| Research Site | Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C524459 | rilotumumab |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided