Liposomal Doxoruicin +/- IMC-3G3 treatment in advanced ovarian cancer

• Research type

  Research Study

• Full title

  Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti- Platelet Derived Growth Factor Receptor-Alpha (PDGFRa) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer

• IRAS ID

  20954

• Sponsor organisation

  ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company

• Eudract number

  2009-009035-30

• Research summary

  Ovarian cancer is a disease with ongoing, significant unmet medical need. In this study, we aim to evaluate the progression-free survival (PFS) in patients with platinum-refractory or platinum-resistant advanced ovarian cancer when treated with the monoclonal antibody IMC-3G3 in combination with liposomal doxorubicin (Arm A) versus liposomal doxorubicin alone (Arm B). Participants will be randomised in a 1:1 ratio to either Arm A or B. Randomisation will be stratified based on previous response to platinum therapy (refractory versus resistant). Participants will receive 20 mg/kg IMC-3G3, administered every 2 weeks intravenously (IV), in combination with 40 mg/m2 liposomal doxorubicin, administered every 4 weeks IV (Arm A), versus 40 mg/m2 liposomal doxorubicin alone administered every 4 weeks IV (Arm B). Throughout the study, participants will visit the study site every 2 weeks. A CT (computed tomography) or MRI (magnetic resonance imaging) scan will be performed every 8 weeks to assess the tumour. Treatment will continue until evidence of disease progression (the cancer starts growing again or new tumours are observed), until the participant experiences unacceptable toxicity, or until the participant withdraws from the study. Participants who discontinue study treatment will be followed for survival every 2 months for as long as the patient remains alive or for up to 2 years from randomisation. Patients randomised to receive liposomal doxorubicin alone may receive IMC-3G3 monotherapy upon disease progression, provided that they otherwise continue to meet criteria for study participation. This study will be sponsored by ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company; 33 ImClone Drive, Branchburg, NJ 08876 USA. A total of 110 patients will be enrolled at up to 20 sites in approximately 3 countries.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  09/H0808/92

• Date of REC Opinion

  27 Oct 2009

• REC opinion

  Further Information Favourable Opinion