Rilotumumab (AMG 102) with ECX in advanced gastric cancer

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) with Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

• IRAS ID

  111952

• Contact name

  David Cunningham

• Sponsor organisation

  Amgen Inc

• Eudract number

  2011-004923-11

• Clinicaltrials.gov Identifier

  NCT00719550

• Research summary

  The primary purpose of this study is to find out if the treatment of rilotumumab in combination with ECX chemotherapy significantly improves overall survival (OS) as compared with rilotumumab-placebo in combination with chemotherapy in subjects with unresectable locally advanced or metastatic MET-positive gastric or gastroesophageal junction cancer. Approximately 450 subjects will be randomized in a 1:1 ratio as follows: • Arm 1: Rilotumumab plus ECX (epirubicin, cisplatin and capecitabine chemotherapy) • Arm 2: Rilotumumab-placebo plus ECXCycles of chemotherapy plus rilotumumab or chemotherapy plus rilotumumab-placebo are planned to be administered every 21 days. All study treatment will cease for individual patients if they experience documented disease progression, withdrawal of consent, or if the study is terminated by the sponsor. Chemotherapy will be given for a maximum of 10 cycles. Rilotumumab and rilotumumab placebo can continue until the final analysis or when all patients still on treatment have received at least 24 months of study treatment, whichever comes last. Any patients who remain on treatment after the final analysis of the study will be allowed to continue treatment at the Investigator's discretion. Tumor assessment scans will be taken at screening, week 13 and then every 12 weeks during study treatment independent of treatment cycle. For patients who discontinue study treatment without documented disease progression, radiographic imaging will continue every 12 weeks until documented disease progression or withdrawal of consent, regardless of the initiation of new systemic anti-cancer therapy. Pharmacokinetic assessment will be conducted for rilotumumab and ECX chemotherapy. Patients at selected sites will participate in rilotumumab and ECX intensive PK (IPK) sampling until approximately 12 evaluable patients per arm have been identified. For non-intensive PK collection, rilotumumab samples will be collected for all patients. Tumor and circulating biomarkers will also be assessed at baseline. Circulating biomarkers will also be assessed during study treatment.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/1825

• Date of REC Opinion

  19 Feb 2013

• REC opinion

  Further Information Favourable Opinion