Study of MORAb-003 with chemotherapy in subjects with ovarian cancer
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer
IRAS ID
125485
Contact name
Hani Gabra
Contact email
Sponsor organisation
Morphotek, Inc.
Eudract number
2014-003812-36
Clinicaltrials.gov Identifier
BB12219, IND number; ENGOT-ov27, ENGOT number; BGOG-ov18, BGOG number
Duration of Study in the UK
5 years, 5 months, 0 days
Research summary
Summary of Research
This is a phase 2 multicentre, double-blind, randomised, placebo-controlled study in subjects with platinum-sensitive ovarian cancer in first relapse. The study is funded by Morphotek, Inc.
The purpose of this study is to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), chemotherapies that are used to treat ovarian cancer, work better alone or when given with an investigational drug called farletuzumab.
Approximately 210 subjects will be included in this study worldwide with approximately 30 participants expected to be recruited in the UK. The duration of participation for individual subjects is expected to be approximately 46 months.
Subjects will be enrolled in a targeted 1:1 stratification ratio into 1 of 2 chemotherapy treatment arms at the investigator’s discretion: carboplatin plus paclitaxel (given by IV every 3 weeks) or carboplatin plus PLD (given by IV every 4 weeks), and then randomised in a 2:1 ratio to receive weekly farletuzumab or placebo (ie, Test Article).
The study will consist of 4 phases: Screening, Combination Treatment, Maintenance Treatment, and Follow-up. At the end of the Combination Treatment Phase, subjects who have not experienced disease progression will enter the Maintenance Treatment Phase until disease progression. Subjects who discontinue Test Article for reasons other than disease progression will be followed radiographically until documentation of disease progression or start of any new anticancer therapy and still be followed for overall survival.
An independent data monitoring committee (DMC) will be utilized to monitor the safety profile, and to enhance safety oversight.
This study involves procedures including: Physical examinations, ECGs, blood and urine tests and CT/MRI scans.
Summary of Results
No – A lay summary was not produced for this study. Eisai's data sharing commitment can be found on our website https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DtUrKMLtn-2FpDt977A2phDvl00GD0cKCDbT3Kng0Bj5J2Ad-2Fq0SqDtVoYn0ayGQrpT-imM_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJU6ONW-2FUgyK9YCWmGlriw4d-2Fj81Mm8aN0-2Bts7GSfoOT5186dkLMgiNxwhdlU47sjbhyxj6zK9c20WdmS2dNGelmVFXPtsDqH2WIb6AUj9R8-2BLhwvFmSQhglBOcssAn5cwxfJlYUXKkPD1JVem3DurwNHvr7nrAq4Y-2FEx-2F6R49ClA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ccdeb50cbdb104944b56908da5b6366b7%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637922779720965178%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=84pR3SMV%2FsGzZNgqVuCXPthhb9Y6z9L2OktjwB1Mhx8%3D&reserved=0
REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0798
Date of REC Opinion
3 Jun 2015
REC opinion
Further Information Favourable Opinion