PhaseIb/II E7050-703Advanced or Metastatic Solid Tumors/Gastric Cancer

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination with Cisplatin and Capecitabine versus Cisplatin and Capecitabine Alone in Patients with Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer

• IRAS ID

  84728

• Contact name

  Abdul Wasat Mansoor

• Sponsor organisation

  Eisai Inc.

• Eudract number

  2011-000774-58

• Clinicaltrials.gov Identifier

  NCT01355302

• Research summary

  This open-label, multicenter, randomized study will consist of a Phase Ib portion: a safety run-in period with 3 ascending doses of E7050; and a Phase II portion: a randomized 2-arm design. Approximately 10 to 15 patients with solid tumors (Phase Ib) and approximately 80 patients with measurable, unresectable locally advanced or metastatic, previously untreated gastric cancer (Phase II) will be enrolled in the study. Patients will only participate in either the Phase Ib or the Phase II portion. The UK will only be taking part in the Phase II part of the study. For the phase II part of the study patients will be randomized in a 1:1 ratio to receive either E7050 in combination with cisplatin plus capecitabine (Arm 1) or cisplatin plus capecitabine alone (Arm 2). The E7050 dose will be the Maxumum Tolerated Dose (MTD) and recommended Phase II dose for E7050 when administered in combination with cisplatin plus capecitabine, as determined in the Phase Ib portion of the study. One cycle of therapy will last 21 days. After 6 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, patients who are experiencing clinical benefit may continue E7050 with or without capecitabine (Arm 1), or capecitabine alone (Arm 2), depending on original treatment regimen, for as long as clinical benefit is sustained and the treatment is well tolerated.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0785

• Date of REC Opinion

  30 Jan 2012

• REC opinion

  Further Information Favourable Opinion