E7050-702 Phase Ib/II study of E7050 Carcinoma Head and Neck

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination with Cetuximab versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

• IRAS ID

  81797

• Contact name

  Andrew Sykes

• Sponsor organisation

  Eisai Inc

• Eudract number

  2011-000773-31

• Clinicaltrials.gov Identifier

  NCT01332266

• Research summary

  This is an Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination with Cetuximab versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck. This study will consist of 2 phases:?½ Phase Ib: a safety run-in period with 3 ascending doses of study drug E7050; ?½ Phase II: a randomized 2-arm design. Approximately 95 patients will be enrolled in the study (10-15 patients in the Phase Ib portion and 80 patients in the Phase II portion). The UK will be taking part in the Phase II part of the study only. For the Phase II part of the study patients will be randomly assigned in a 1:1 ratio to receive either E7050 in combination with cetuximab or cetuximab alone. The E7050 dose will be the Maximum Tolerated Dose (MTD) and recommended Phase II dose for E7050 when administered in combination with cetuximab, as determined in the Phase Ib portion of the study. Patients will receive study treatment (E7050 plus cetuximab [Arm 1] or cetuximab alone [Arm 2]) for six 28-day cycles (24 weeks), until the occurrence of progressive disease (PD),unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurs first. After 6 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, patients who are experiencing clinical benefit (complete response (CR), partial response (PR), or stable disease (SD) may continue E7050, with or without cetuximab (Arm 1), or may continue cetuximab alone (Arm 2), E7050 plus cetuximab, cetuximab alone or E7050 alone (Arm 1), or may continue cetuximab alone (arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated. Note that single-agent therapy (E7050 or cetuximab) will only be offered to patients in Arm 1 who are experiencing unacceptable toxicity that can be attributed to 1 agent of the combination. Patients will be followed for up to 1 year until death following completion of therapy.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/NW/0835

• Date of REC Opinion

  20 Dec 2011

• REC opinion

  Favourable Opinion