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| ID | Type | Description | Link |
|---|---|---|---|
| 20110251 | Other Identifier | Amgen |
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This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilotumumab Monotherapy | Experimental | Cohort 1A: Rilotumumab 10 mg/kg IV Q2W Cohort 1B: Rilotumumab 20 mg/kg IV Q2W Cohort 1C (if needed): Rilotumumab 15 mg/kg IV Q2W |
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| Rilotumumab plus CX | Experimental | Cohort 2A: Rilotumumab 15 mg/kg IV Day 1 Q3W Cisplatin 80 mg/m2 IV (max of 6 cycles) Day 1 Q3W Capecitabine 1000 mg/m2 PO BID, Days 2-14 Q3W Cohort 2B (if needed): Rilotumumab 10 mg/kg IV Day 1 Q3W Cisplatin 80 mg/m2 IV (max of 6 cycles) Day 1 Q3W Capecitabine 1000 mg/m2 PO BID, Days 2-14 Q3W |
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| 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 (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Part1: Dose-limiting toxicities (DLT) for each dose level of rilotumumab tested | DLTs are defined as grade 3 or higher adverse events that are related to rilotumumab during the first cycle of therapy. This does not include specific toxicities (eg nausea and vomiting) that are common in cancer patients unless specific criteria are met. | 28 days |
| Part 2: Dose-limiting toxicities (DLT) for each dose level of rilotumumab in combination with cisplatin and capecitabine (CX) chemotherapy tested | DLTs are defined as grade 3 or higher adverse events that are related to rilotumumab or the combination of rilotumumab and CX during the first cycle of therapy. This does not include specific toxicities (eg nausea and vomiting) that are common in cancer patients unless specific criteria are met. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Incidence of AEs, clinical laboratory abnormalities and anti-rilotumumab antibodies. | AEs and laboratory abnormalities are reported by CTCAE (version 3.0) criteria | 4 months average |
| Part 1: Pharmacokinetics parameters of rilotumumab monotherapy as measured by: Maximum concentration, time to achieve maximum concentration, observed minimum concentration, area under the concentration-time curve, terminal elimination half-life. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28973403 | Derived | Doi T, Yamaguchi K, Komatsu Y, Muro K, Nishina T, Nakajima TE, Tang R, Yang H, Zhang Y, Jung AS, Ang A, Yasui H. A Phase 1/1b tolerability study of rilotumumab alone or in combination with cisplatin and capecitabine in Japanese patients with gastric cancer. Jpn J Clin Oncol. 2017 Nov 1;47(11):1002-1009. doi: 10.1093/jjco/hyx114. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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|
| Rilotumumab | Drug | Drug: Rilotumumab Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells. Drug: Cisplatin A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death). Drug: Capecitabine 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. |
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| 4 months average |
| Part 1: Evaluate efficacy based on the treatment effects of rilotumumab monotherapy as measured by the following: Objective Response Rate, duration of response, progression-free survival. | 4 months average |
| Part 2: Incidence of AEs, clinical laboratory abnormalities and anti-rilotumumab antibodies not defined as DLTs. | AEs and laboratory abnormalities are reported by CTCAE (version 3.0) criteria | 7 months average |
| Part 2: Pharmacokinetics parameters of rilotumumab in combination with cisplatin and capecitabine as measured by: Maximum concentration, observed minimum concentration, area under the concentration-time curve. | 7 months average |
| Part 2: Evaluate efficacy based on the treatment effects of rilotumumab in combination with cisplatin and capecitabine as measured by the following: Objective Response Rate, duration of response, progression-free survival, overall survival. | 7 months average |
| Kashiwa-shi |
| Chiba |
| 277-8577 |
| Japan |
| Research Site | Matsuyama | Ehime | 791-0280 | Japan |
| Research Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Research Site | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
| Research Site | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Research Site | Suntou-gun | Shizuoka | 411-8777 | Japan |
| 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 |
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| ID | Term |
|---|---|
| C524459 | rilotumumab |
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