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Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.
Primary Objective(s):
Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.
Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2 Arm C | Placebo Comparator | AMG 102 placebo plus ECX |
|
| Phase 1b | Other | Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed. |
|
| Phase 2 Arm B | Active Comparator | AMG 102 at 7.5mg/kg plus ECX |
|
| Phase 2 Arm A | Active Comparator | AMG 102 at 15mg/kg plus ECX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Administered at 625mg/m2 BID orally every day while on study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS), as measured by RECIST per local review | Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only). | Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. | |
| Incidence of adverse events, significant laboratory value changes form baseline and anti-AMG 102 antibody formation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Doshi S, Loh E, Oliner K, Gisleskog PO, Perez Ruixo JJ, Zhang Y, Zhu M.Exposure survival modeling.Journal-001088; | ||
| 24965569 | Background | Iveson T, Donehower RC, Davidenko I, Tjulandin S, Deptala A, Harrison M, Nirni S, Lakshmaiah K, Thomas A, Jiang Y, Zhu M, Tang R, Anderson A, Dubey S, Oliner KS, Loh E. Rilotumumab in combination with epirubicin, cisplatin, and capecitabine as first-line treatment for gastric or oesophagogastric junction adenocarcinoma: an open-label, dose de-escalation phase 1b study and a double-blind, randomised phase 2 study. Lancet Oncol. 2014 Aug;15(9):1007-18. doi: 10.1016/S1470-2045(14)70023-3. Epub 2014 Jun 22. | |
| Background | Oliner K.BM Ph2 Gastric.Journal-004521; | ||
| Background | TBD.Ph2 Gastric Exposure Response.Journal-004521; |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D015251 | Epirubicin |
| C524459 | rilotumumab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| Epirubicin | Drug | Administered day 1 of each cycle at 50mg/m2 IV. |
|
| AMG 102 | Drug | Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment. |
|
| Cisplatin | Drug | Administered day 1 of each cycle at 60mg/m2 IV. |
|
| Placebo | Drug | AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution |
|
| Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. |
| Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102 | Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. |
| Background | TBD.Ph2 Gastric PRO.Journal-004521; |
| Background | Zhu.20060317 ER data.Journal-000728; |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |