PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
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|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|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|