JVDB: Second Line Gastric/Gastroesophageal Cancer

• Research type

  Research Study

• Full title

  Randomized Phase 2 Trial Evaluating Pharmacokinetics and Safety of Four Ramucirumab Dosing Regimens in Second Line Gastric or Gastroesophageal Junction Adenocarcinoma

• IRAS ID

  176779

• Contact name

  Joanna Warner-Smith

• Contact email

  Warner-Smith_Joanna@network.lilly.com

• Sponsor organisation

  Eli Lilly & Company

• Eudract number

  2014-003791-23

• Duration of Study in the UK

  1 years, 1 months, 1 days

• Research summary

  Gastric (stomach) and Gastroesphageal junction (GEJ)) cancers represent a leading cause of cancer deaths. Gastric cancer is the fifth most common cancer in the world.

  Ramucirumab works to inhibit a process called angiogenesis. Angiogenesis inhibitor treatments are currently being looked at to treat cancers. Angiogenesis is a process through which blood vessels form from pre-existing blood vessels. It is a fundamental step in the transition of tumours from a benign state to a malignant one. Ramucirumab also inhibits vasculogenesis which is another process that can potentially help tumours to grow.

  Ramucirumab has had marketing authorisation since April 2014 in the USA and Dec 2014 in the EU as a second-line treatment to be used on its own and with another treatment called Paclitaxel to treat patients with gastric cancers if they have already had previous treatment with fluoropyrimidine or a platinum containing chemotherapy treatment.

  This study will, therefore, randomise patients into 4 different treatment regimens:

  Arm 1 (8mg/kg-Standard Dosing Regimen) given twice during a 28 day cycle
  Arm 2 (12mg/kg) given twice during a 28 day cycle
  Arm 3 (6mg/kg) given 4 times during a 28 day cycle
  Arm 4 (8mg/kg) given twice during a 21 day cycle

  To be eligible to enter this study patients must have advanced gastric or gastroesphageal junction cancer and have experienced disease progression within 4 months after their last dose of first-line treatment.Patients must be 18 years old or over.

  Study assessments will include: Physical examinations, ECGs, Questionnaire completion, blood and urine tests and radiological scans.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  15/SC/0430

• Date of REC Opinion

  2 Sep 2015

• REC opinion

  Further Information Favourable Opinion