PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
Verified February 2015 by Glycotope GmbH
Information provided by (Responsible Party):
First received: July 4, 2013
Last updated: February 26, 2015
Last verified: February 2015
Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian, fallopian tube or primary peritoneal cancer.
Ovarian Epithelial Cancer Recurrent
Fallopian Tube Cancer
Primary Peritoneal Cancer With High-grade (Grade 2 or 3) Serous Features or a Serous Component
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
Primary Outcome Measures:
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 or fallopian tube carcinoma or primary peritoneal 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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2016 (Final data collection date for primary outcome measure)
1700mg, i.v., q3w
start dose 500mg at C0D1 maintenance dose 1700mg at CxD1 Number of Cycles: until progression or unacceptable toxicity develops.
Placebo Comparator: Placebo
start dose matching 500mg at C0D1 maintenance dose matching 1700mg at CxD1 Number of Cycles: until progression or unacceptable toxicity develops.
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 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 may also be stored for other further specified biomarker assessments).
- Patients should have received at least 2 lines but not more than 5 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 ≤6 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.
- Progression-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 ≥3.0 × 109/L
- Absolute neutrophil count ≥1.5 × 109/L
- Platelet count ≥100 × 109/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. -
- 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 (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.
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS), 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 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 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01899599
||Jonathan Ledermann, MD
||UCL Cancer Institute, 90 Tottenham Court Road, London W1T 4TJ, UK
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 4, 2013
||February 26, 2015
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:
ClinicalTrials.gov processed this record on September 02, 2015
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site