IMPACT Study

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Clinical Study to Evaluate Efficacy and Safety of a Maintenance Therapy with Immunomodulator MGN1703 in Patients with Advanced Colorectal Carcinoma with Disease Control after Initial First-line Therapy (IMPACT Study)

• IRAS ID

  63615

• Contact name

  Rob Glynne-Jones

• Sponsor organisation

  MOLOGEN AG

• Eudract number

  2009-017432-40

• ISRCTN Number

  ISRCTN

• Research summary

  Colorectal cancer is one of the most frequently diagnosed cancers in humans. MGN1703 is a drug in clinical testing phase and is being developed for the treatment of advanced cancer of the colon or the rectum. The overall purpose of the study is to evaluate efficacy, immunogenicity and safety of MGN1703 administered twice weekly as maintenance treatment in patients with advanced colorectal carcinoma with disease control after initial first-line therapy.The study is sponsored by a pharmaceutical Company MOLOGEN AG. The treatment with MGN1703 is a new therapeutic approach based on an immunological strategy (acting on the bodies?? own defense system) for the treatment of malignant diseases. MNG1703 increases the response of the immune system to antigens already present in the patient??s body.Males and females over the age of 18 years who meet all inclusion and exclusion criteria and have histologically confirmed colorectal carcinoma are eligible to be enrolled into the study. The patient will be treated with MGN1703 or with placebo for at least 24 weeks (6 months) There will be one center in The UK Treatment starts after a 2-week evaluation phase. The study medication will be injected subcutaneously twice a week. The patient will be seen 8 times in the first 24 weeks & then 3 monthly post study up to 144 weeks. The following procedures will be performed at the patient visits, A CT scan will be performed at regular intervals & the patient will undergo a physical examination, have bloods taken for safety & other tests, have the tolerability of the treatment assessed, adverse events reported , vital signs recorded and complete quality of life questionnaires.

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/72

• Date of REC Opinion

  13 Dec 2010

• REC opinion

  Further Information Favourable Opinion