PankoMab-GEX™ in recurrent ovarian cancer GEXMab 25201 v1.0 12Mar13
Research type
Research Study
Full title
A Double-blind, Placebo-controlled, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of Maintenance Therapy With PankoMab-GEX™ After Chemotherapy in Patients With Recurrent Epithelial Ovarian Carcinoma
IRAS ID
129260
Contact name
Jonathan Ledermann
Contact email
Sponsor organisation
Glycotope GmbH
Eudract number
2013-000931-28
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
PanKoMab-GEX is a new monoclonal antibody which recognises and binds to a compound in tumour cells called TA-MUC1. It is thought that this may cause an immune response which may be toxic to tumour cells expressing TA-MUC1. PankoMab-GEX is being developed for the treatment of ovarian and non-small cell lung cancer. In a phase I dose escalation study, 74 Patients with advanced solid tumours including ovarian cancer (23%) were treated, PantoMab-GEX was well tolerated at all doses, twenty-one patients experienced stable disease as best response. The risk-benefit balance was deemed positive.
The purpose of this study is to test if PankoMab-GEX™ (1700 mg) is an effective and safe maintenance treatment in patients who have had chemotherapy for recurrent ovarian carcinoma. Maintenance therapy may be given after completion of chemotherapy to try to prevent or delay a recurrence of the cancer. In this study PankoMab-GEX will be compared to placebo (on a 2 to 1 ratio). Subjects will be those in whom a prior tumour biopsy was positive for TA-MUC1. They will be allocated randomly in a double-blind fashion. The primary endpoint of this study will be measurement of Progression-Free Survival.
Treatment will be administered on a 3 weekly cycle until progression of disease/or after premature discontinuation of study medication for any other reason. After progression of disease, subjects will enter the long-term survival follow-up phase of the study and will be contacted by phone every 3 months for a minimum duration of 12 months.
Throughout the study, tumour size will be assessed using CT or MRI assessment. Patients will be asked to complete quality of life questionnaires and blood samples will be collected to assess safety parameters, drug levels and immune and tumour markers.
This study will be conducted in 210 patients at up to 40 site in up to 10 countries, mainly in Europe.REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0354
Date of REC Opinion
6 Sep 2013
REC opinion
Further Information Favourable Opinion