- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01899599
PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
October 20, 2020 updated by: Glycotope GmbH
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
Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian, fallopian tube or primary peritoneal cancer.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The study is to evaluate the efficacy of PankoMab-GEX vs Placebo in maintaining response after 2nd to 5th line of chemotherapy in patients with epithelial ovarian or fallopian tube or primary peritoneal 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 start of study medication must not have lasted more than 12 months.
Study Type
Interventional
Enrollment (Actual)
216
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 13353
- Investigator
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Kiel, Germany, 24103
- Investigator
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Munich, Germany, 80337
- Investigator
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Munich, Germany, 81675
- Investigator
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Regensburg, Germany, 91054
- Investigator
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Stuttgart, Germany, 70376
- Investigator
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Budapest, Hungary, 1088
- Investigator
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Debrecen, Hungary, 4035
- Investigator
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Szeged, Hungary, 6720
- Investigator
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Meldola, Italy, 47014
- Investigator
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Milan, Italy, 20133
- Investigator
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Milan, Italy, 20141
- Investigator
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Rome, Italy, 00168
- Investigator
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Bydgoszcz, Poland, 85796
- Investigator
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Gdansk, Poland, 80402
- Investigator
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Lublin, Poland, 20090
- Investigator
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Olsztyn, Poland, 10513
- Investigator
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Poznan, Poland, 60569
- Investigator
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Rzeszow, Poland, 35242
- Investigator
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Brasov, Romania, 500091
- Investigator
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Bucharest, Romania, 010825
- Investigator
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Cluj-Napoca, Romania, 400015
- Investigator
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Cluj-Napoca, Romania, 400058
- Investigator
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Craiova, Romania, 200347
- Investigator
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Oradea, Romania, 410469
- Investigator
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Timisoara, Romania, 300167
- Investigator
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Timisoara, Romania, 300239
- Investigator
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Kazan, Russian Federation, 450029
- Investigator
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Moscow, Russian Federation, 111123
- Investigator
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Moscow, Russian Federation, 115478
- Investigator
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Moscow, Russian Federation, 129128
- Investigator
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Oryol, Russian Federation, 302020
- Investigator
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Pyatigorsk, Russian Federation, 357502
- Investigator
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Rostov-on-Don, Russian Federation, 344037
- Investigator
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St Petersburg, Russian Federation, 188663
- Investigator
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St. Petersburg, Russian Federation, 197758
- Investigator
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St. Petersburg, Russian Federation, 198255
- Investigator
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Volgograd, Russian Federation, 404133
- Investigator
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Yaroslavl, Russian Federation, 150040
- Investigator
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Barcelona, Spain, 08916
- Investigator
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Madrid, Spain, 28007
- Investigator
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Madrid, Spain, 28040
- Investigator
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Madrid, Spain, 28041
- Investigator
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Madrid, Spain, 28046
- Investigator
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Madrid, Spain, 28223
- Investigator
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Valencia, Spain, 46009
- Investigator
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London, United Kingdom, SW3 6JJ
- Investigator
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London, United Kingdom, W1T 4TJ
- Investigator
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Northwood, United Kingdom, HA6 2RN
- Investigator
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Sutton, United Kingdom, SM2 5PT
- Investigator
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female patients ≥18 years of age
- Histologically-confirmed, TA-MUC1-positive, recurrent epithelial ovarian, or fallopian-tube cancer or primary peritoneal cancer with high-grade (Grade 2 or 3) serous features or a serous component
- Availability of tumor tissue samples (slices or block) for immune-histological confirmation of TA-MUC1 status (tissue samples could also be stored for other further specified biomarker assessments)
- Patients were to have received at least 2 lines but not more than 5 lines of chemotherapy prior to start of maintenance treatment; neo-adjuvant lines did not count as previous lines of treatment
- Patients had to have a documented response to or SD following the most recent line of chemotherapy (any regimen and duration in accordance with local or international guidelines or within IEC-approved studies) and received the last dose of said chemotherapy ≤6 weeks prior to randomization (response to prior chemotherapy was defined as a PR/CR according to radiological response criteria and/or a confirmed decline in tumor marker CA125 ≥50% from the pre-treatment value for patients who had a pre-treatment value ≥2 x the upper limit of normal [ULN]; SD was defined as stable disease according to radiological response criteria with a confirmed lack of increase in tumor marker CA125 from the pre-treatment value for patients who had a pre-treatment value ≥2 × ULN and no clinical progression). Prior to randomization, CA125 had to be below the ULN, or CA125 levels were not to increase >15% within a time frame >7 days if above the ULN
- Progression-free interval of ≤12 months immediately preceding the chemotherapy to which the patient had just responded
- Sensitive or resistant to the most recent platinum-based chemotherapy preceding the chemotherapy to which the patient had just responded (sensitivity was thereby defined as a recurrence of disease >6 to ≤12 months after the end of platinum-based chemotherapy, and resistantance was defined as a recurrence of disease ≤6 months after the end of the platinum-based chemotherapy)
- Eastern Cooperative Oncology Group (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 ≥3.0 × 109/L
- Absolute neutrophil count ≥1.5 × 109/L- Platelet count ≥100 × 109/L
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <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 post-menopausal for >1 year) had to 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). (Although pregnancy was unlikely to occur in this patient population, any patient with childbearing potential had to 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)
- Progression-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 (prior anti-MUC1 therapy was not permitted at any time)
- Limited-field radiotherapy ≤30 days before randomization (extensive prior radiotherapy during or following the last line of chemotherapy was not permitted; radiotherapy prior to the last line of chemotherapy was 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 pre-medication used in this study (paracetamol/acetaminophen, H1 and/or H2 receptor antagonists, or steroids)
- Clinical evidence of brain metastasis or leptomeningeal involvement
- Patients with second primary cancer, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ, Stage 1 Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years
- Primary or secondary immune deficiency
- Clinically active infections >Grade 2 using NCI-CTCAE version 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 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 (steroids used for pre-medication were permitted)
- Active drug or alcohol abuse
- Any uncontrolled medical condition that could have 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-GEX™ administration
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: PankoMab-GEX
1700mg, i.v., q3w
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start dose 500mg at C0D1, maintenance dose 1700mg at CxD1, Number of Cycles: until progression or unacceptable toxicity develops.
Other Names:
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PLACEBO_COMPARATOR: Placebo
matching placebo
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start dose matching 500mg at C0D1, maintenance dose matching 1700mg at CxD1, Number of Cycles: until progression or unacceptable toxicity develops.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression free survival
Time Frame: from baseline till progression of disease or death
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PFS will be determined by radiographic progression based on modified RECIST 1.1 or death of any cause.
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from baseline till progression of disease or death
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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: from randomization until end of treatment
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Safety will be determined on the occurrence of infusion-related reactions (IRR), treatment emergent adverse events (TEAE) and treatment emergent serious adverse events (TESAE).
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from randomization until end of treatment
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Patient reported outcome
Time Frame: from randomization until end of treatment
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To evaluate the quality of life (QoL) and other health and health-economy related outcomes
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from randomization until end of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Ledermann, MD, UCL Cancer Institute, 90 Tottenham Court Road, London W1T 4TJ, UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2013
Primary Completion (ACTUAL)
April 20, 2017
Study Completion (ACTUAL)
July 28, 2017
Study Registration Dates
First Submitted
July 4, 2013
First Submitted That Met QC Criteria
July 12, 2013
First Posted (ESTIMATE)
July 15, 2013
Study Record Updates
Last Update Posted (ACTUAL)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- GEXMab25201
- 2013-000931-28 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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