PankoMab-GEX Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer

Transcription

1 1 von :26 A service of the U.S. National Institutes of Health Trial record 1 of 1 for: GEXMab25201 Previous Study Return to List Next Study PankoMab-GEX Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer This study is currently recruiting participants. Verified December 2013 by Glycotope GmbH Sponsor: Glycotope GmbH Information provided by (Responsible Party): Glycotope GmbH ClinicalTrials.gov Identifier: NCT First received: July 4, 2013 Last updated: December 16, 2013 Last verified: December 2013 History of Changes Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record Purpose Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian cancer. Condition Intervention Phase Epithelial Ovarian Cancer Drug: PankoMab-GEX Drug: Placebo Phase 2 Study Type: Interventional

2 2 von :26 Study Design: Official Title: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment 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 Resource links provided by NLM: MedlinePlus related topics: Cancer Ovarian Cancer Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer U.S. FDA Resources Further study details as provided by Glycotope GmbH:

3 3 von :26 Primary Outcome Measures: Progression free survival [ Time Frame: from baseline till progression of disease or death ] [ Designated as safety issue: No ] PFS will be determined by radiographic progression based on modified RECIST 1.1 or death of any cause. Secondary Outcome Measures: To assess the safety and tolerability of maintenance therapy with single-agent PankoMab-GEX compared to placebo in patients with metastatic or recurrent ovarian carcinoma. [ Time Frame: 3 weekly ] [ Designated as safety issue: Yes ] 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 ] [ Designated as safety issue: No ] To evaluate the quality of life (QoL) and other health and health-economy related outcomes Estimated Enrollment: 210 Study Start Date: September 2013 Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure) Arms Experimental: PankoMab-GEX 1700mg, i.v., q3w Placebo Comparator: Placebo matching placebo Assigned Interventions Drug: PankoMab-GEX Drug: Placebo Detailed Description: The study is to evaluate the efficacy of PankoMab-GEX vs Placebo in maintaining response after 2nd to 4th line of chemotherapy in patients with epithelial ovarian cancer. Patients must have responded to platinum based chemotherapy in a previous line, while the response to the most recent Pt-based chemotherapy must not have lasted more than 12 months. In addition the response between most recent 2 lines of chemotherapy prior

4 start of study medication must not have lasted more than 12 months. Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 18 Years and older Female No Criteria Inclusion Criteria: Female patients 18 years of age. Histologically-confirmed, TA-MUC1 positive, recurrent epithelial ovarian carcinoma. Availability of tumor tissue samples (slices or block) for immune-histological confirmation of TA-MUC1 status (tissue samples may also be stored for other further specified biomarker assessments). Patients should have received at least 2 lines but not more than 4 lines of chemotherapy prior to start of maintenance treatment. Documented response to or stable disease following the most recent line of chemotherapy (any regimen and duration in accordance with local or international guidelines or within independent ethics committee [IEC] approved studies) and received last dose of said chemotherapy 5 weeks prior to randomization (response to prior chemotherapy is defined as a partial/complete response according to radiological response criteria and/or a confirmed decline in tumor marker CA125 50% from the pretreatment value 2 the upper limit of normal [ULN]; stable disease is defined as stable disease according to radiological response criteria with a confirmed lack of increase in tumor marker CA125 from the pretreatment value for patients who have a pretreatment value 2 ULN and no clinical progression). CA125 prior to randomization must be below ULN or CA125 levels must not increase >15% within a time frame >7 days if above ULN. Treatment-free interval of 12 months immediately preceding the chemotherapy to which the patient has just responded. Sensitive or resistant to the most recent platinum-based chemotherapy preceding the chemotherapy to which the patient has just responded (sensitive is thereby defined as a recurrence of disease >6 to 12 months after end of platinum-based chemotherapy and resistant is defined as a recurrence of disease 6 months after the end of platinum-based chemotherapy). ECOG performance status 1. Recovered from all chemotherapy-related toxicities to grade 1 or grade 0 according to the NCI CTCAE version 4.0, with the exception of alopecia (any grade) and peripheral neuropathy ( grade 2). Adequate bone marrow and hepatic function at Screening: Hemoglobin 9 g/dl White blood cell count /L 4 von :26

5 5 von :26 Absolute neutrophil count /L Platelet count /L Aspartate aminotransferase and alanine aminotransferase <3 ULN (<5 ULN in case of liver metastases) Bilirubin <1.5 ULN (<3 ULN in case of liver metastases) Creatinine <1.5 ULN Any patient with childbearing potential (i.e., not surgically sterile or postmenopausal for >1 year) must use highly effective contraceptives with a Pearl index <1% according to the Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95) of the European Medicines Agency (EMA) (Note: although pregnancy is unlikely to occur in this patient population, any patient with childbearing potential will be withdrawn from the study in the event of pregnancy). Life expectancy >3 months. Ability and willingness to give written informed consent. - Exclusion Criteria: Refractory to platinum-based chemotherapy (defined as remained progressive or became progressive under any previous platinum-based regimen). Treatment-free interval of >12 months after the most recent antecedent platinum-based chemotherapy regimen. Concomitant anti-tumor therapy or immunotherapy. Treatment with monoclonal antibodies or investigational agents 30 days before randomization (Note: prior anti-muc1 therapy is not permitted at any time). Limited-field radiotherapy 30 days before randomization (Note: extensive prior radiotherapy during or following the last line of chemotherapy is not permitted; radiotherapy prior to the last line of chemotherapy is permitted). Prior allergic reaction to a monoclonal antibody, grade 3 IRR or any grade 4 reaction to a monoclonal antibody. Known sensitivity to any component of the test product. Contraindication to the premedications used in this study (paracetamol/acetaminophen, H1 and/or H2 receptor antagonists, and steroids). Clinical evidence of brain metastasis or leptomeningeal involvement. Primary or secondary immune deficiency. Clinically active infections >grade 2 using NCI CTCAE v 4.0. Active hepatitis B or C or infection with human immunodeficiency virus (HIV). Myocardial infarction within 6 months prior to Screening. Symptomatic congestive heart failure (New York Heart Association grade 3 or 4), unstable angina pectoris within 6 months prior to

6 6 von : Screening, significant cardiac arrhythmia or history of stroke or transient ischemic attack within 1 year prior to Screening. Prior or planned major surgery within 30 days prior to randomization and/or incomplete recovery from prior surgery. Concomitant use of systemic steroids, except for inhaled, topical or nasal application within 30 days prior to randomization (Note: steroids used for premedication are permitted). Active drug or alcohol abuse. Any uncontrolled medical condition that may put the patient at high risk during treatment with an investigational drug, including unstable diabetes mellitus, vena cava syndrome, or chronic symptomatic respiratory disease. Pregnancy or lactation. Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons. Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous PankoMab-GEXTM administration.- Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT Contacts Contact: Frank Zimmermann, PhD ext 2652 frank.zimmermann@glycotope.com Show 39 Study Locations Sponsors and Collaborators Glycotope GmbH Investigators Principal Investigator: Jonathan Ledermann, MD UCL Cancer Institute, 90 Tottenham Court Road, London W1T 4TJ, UK More Information No publications provided

7 Responsible Party: Glycotope GmbH ClinicalTrials.gov Identifier: NCT History of Changes Other Study ID Numbers: GEXMab25201, Study First Received: July 4, 2013 Last Updated: December 16, 2013 Health Authority: Germany: Paul-Ehrlich-Institut Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines Italy: The Italian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Agency for Medicines and Medical Devices Russia: Ministry of Health of the Russian Federation Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency Additional relevant MeSH terms: Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type ClinicalTrials.gov processed this record on January 10, von :26