PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT01899599|
Recruitment Status : Active, not recruiting
First Posted : July 15, 2013
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Epithelial Cancer Recurrent Fallopian Tube Cancer Primary Peritoneal Cancer||Drug: Gatipotuzumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||September 2013|
|Primary Completion Date :||June 16, 2017|
|Estimated Study Completion Date :||November 2017|
1700mg, i.v., q3w
start dose 500mg at C0D1 maintenance dose 1700mg at CxD1 Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: PankoMab-GEX
Placebo Comparator: Placebo
start dose matching 500mg at C0D1 maintenance dose matching 1700mg at CxD1 Number of Cycles: until progression or unacceptable toxicity develops.
- Progression free survival [ Time Frame: from baseline till progression of disease or death ]PFS will be determined by radiographic progression based on modified RECIST 1.1 or death of any cause.
- To assess the safety and tolerability of maintenance therapy with single-agent PankoMab-GEX™ compared to placebo in patients with metastatic or recurrent ovarian or fallopian tube carcinoma or primary peritoneal carcinoma. [ Time Frame: 3 weekly ]Safety will be determined on the occurrence of infusion-related reactions (IRR, treatment emergent adverse events (TEAE) and treatment emergent serious adverse events (TESAE.
- Patient reported outcome [ Time Frame: every 9 weeks ]To evaluate the quality of life (QoL) and other health and health-economy related outcomes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899599
Show 50 Study Locations
|Principal Investigator:||Jonathan Ledermann, MD||UCL Cancer Institute, 90 Tottenham Court Road, London W1T 4TJ, UK|