Clinical trial · Interventional
A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Rilotumumab | Drug | Rilotumumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rilotumumab
- description
- Rilotumumab plus Cisplatin and Capecitabine (CX).
- interventionNames
- Drug: Rilotumumab
- Drug: Cisplatin
- Drug: Capecitabine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
- interventionNames
- Drug: Placebo
- Drug: Cisplatin
- Drug: Capecitabine
Primary outcomes (2)
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Key Inclusion Criteria: * Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. * Tumor MET-positive by immunohistochemistry (IHC). * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. * Male or female subject greater than or equal to 20 years of age at the time of informed consent. Key Exclusion Criteria: * Human epidermal growth factor receptor 2 (HER2)-overexpressing locally advanced or metastatic gastric or GEJ adenocarcinoma. * Previous systemic therapy for locally advanced or metastatic gastric or GEJ or lower esophageal adenocarcinoma. * Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization. * Squamous cell histology.
References
Publications (0)
Data not yet available