Study of IMC-1121B for Ovarian, Fallopian, or Peritoneal Carcinoma

  • Research type

    Research Study

  • Full title

    A Phase 2, Non-randomized, Open-label, Multicenter Study of IMC-1121B in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

  • Sponsor organisation

    ImClone Systems Incorporated

  • Eudract number

    2007-0067-17-17

  • ISRCTN Number

    N/A

  • Clinicaltrials.gov Identifier

    N/A

  • Research summary

    Worldwide, ovarian cancer accounts for about 7% of all cancer cases among women, with an estimated 204,499 new cases and approximately 124,860 deaths reported in 2002. This accounts for the 6th most common cancer and 7th highest cause of death from cancer in women.IMC-1121B is an investigational drug under development by ImClone Systems Incorporated. This study is a phase-2, multi-centre study, in which persistent or re-current epithelial ovarian, fallopian tube, or primary peritoneal cancer patients will receive IMC-1121B.The purpose of this study is to determine if IMC-1121B slows cancer growth and to evaluate the effects of this treatment. There will be additional blood samples taken to check how long the study drug stays in the blood and how the body processes it (at baseline, week-8, week-12, end of study, or more often in case of unexpected events). There is also an option for patients to consent to the use of their previously taken tumour tissue samples for Biomarker studies and other future research.Study assessments may include, Physical Examinations, Blood/Urine tests, Echocardiogram/MUGA scan, Electrocardiogram, CT/MRI/Chest X-rays.The treatment period is divided into cycles. Each cycle is 4-weeks (28 days). Patients will receive IMC-1121B through a needle in the vein for about one hour, on the 1st day and on the 15th day (every other week) of each cycle for a total of 12 cycles, as long as the disease is not getting worse, there are no excessive side effects, and no other reasons for withdrawal.Approximately 55 patients will be enrolled into the study over an 18 month period in two stages. The first stage of enrolment (23 patients) is expected to be 7 months in duration, and the second stage (32 patients), is expected to be 11 months in duration. The two-stage design will assess safety and efficacy.

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    08/H0504/146

  • Date of REC Opinion

    1 Dec 2008

  • REC opinion

    Further Information Favourable Opinion