DNIB0600A in patients with Platinum-Resistant Ovarian Cancer
Research type
Research Study
Full title
A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE II TRIAL EVALUATING THE SAFETY AND ACTIVITY OF DNIB0600A COMPARED TO PEGYLATED LIPOSOMAL DOXORUBICIN ADMINISTERED INTRAVENOUSLY TO PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER
IRAS ID
138131
Contact name
Susana Banerjee
Contact email
Sponsor organisation
Genentech Inc
Eudract number
2012-005776-34
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Ovarian Cancer is the 7th most common cause of cancer death in women worldwide. 70% of patients are first diagnosed with already advanced ovarian cancer. Treatment with surgery and platinum based chemotherapy is effective however the disease eventually relapses and becomes platinum resistant. At this stage there is no optimal treatment strategy and overall survival is 9 -12 months. New effective treatments are needed.
DNIB0600A is an antibody-drug conjugate consisting of a human antibody linked to a potent anti cancer drug. The antibody part of DNIB0600A targets a protein found on the surface of most ovarian cancer cells. Approximately 92 patients will be enrolled into this study at approximately 30 sites worldwide. Participants who provide written consent and meet all eligibility criteria will be randomly assigned in a 1:1 ratio to one of the following:
Arm A: Study drug: DNIB0600A on Day 1 of each treatment cycle (one cycle = 21 days)
Arm B: Standard treatment: Pegylated Liposomal Doxorubicin (40 mg/m2) on Day 1 of each treatment cycle (one cycle = 28 days)This study consists of:
Screening period: assessment for eligibility. Patients will be randomised to study treatment after eligibility is approved
Treatment period: patients may receive treatment with either DNIB0600A or Pegylated Liposomal Doxorubicin until one of the following occurs: significant toxicity, disease progression, or withdrawal from the study.
Follow up Period: after drug discontinuation patients will be followed until withdrawal of consent, death, loss to follow-up or study closure
The study involves the following procedures some of which are done as standard of care but which may be done more frequently: Physical examinations, Electrocardiograms (a measurement of heart rhythm), Echocardiogram or MUGA Scans (scans that measure how well the heart is pumping blood), Vital signs, Blood and urine tests, radiographic tumour assessment and patient questionnaires.REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/1581
Date of REC Opinion
14 Jan 2014
REC opinion
Further Information Favourable Opinion