Study to evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX TM after chemotherapy in patients with recurrent epithelial ovarian carcinoma.
- Conditions
- Recurrent Epithelial Ovarian CarcinomaMedDRA version: 16.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000931-28-ES
- Lead Sponsor
- Glycotope GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 210
1. Female patients over or equal to 18 years of age.
2. Histologically confirmed, TA-MUC1 positive, recurrent epithelial ovarian carcinoma.
3. 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).
4. Patients should have received at least 2 lines but not more than 4 lines of chemotherapy prior to start of maintenance treatment.
5. 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 maximum 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 higher or equal to 50% from the pretreatment value for patients who have a pretreatment value higher or equal to 2 x 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 higher or equal to 2 x 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.
6. Treatment-free interval of maximum12 months immediately preceding the chemotherapy to which the patient has just responded.
7. 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 more than 6 months to less or equal to 12 months after end of platinum-based chemotherapy and resistant is defined as a recurrence of disease less or equal to 6 months after the end of platinum-based chemotherapy).
8. Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1.
9. Recovered from all chemotherapy-related toxicities to grade 1 or grade 0 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, with the exception of alopecia (any grade) and peripheral neuropathy (grade lower or equal to 2).
10. Adequate bone marrow and hepatic function at Screening:
- Hemoglobin over or equal to 9 g/dL
- White blood cell count over or equal to 3.0 × 10^9/L
- Absolute neutrophil count over or equal to 1.5 × 10^9/L
- Platelet count over or equal to 100 × 10^9/L
- Aspartate aminotransferase and alanine aminotransferase lower than 3 × ULN (lower than 5 × ULN in case of liver metastases)
- Bilirubin lower than 1.5 × ULN (lower than 3 × ULN in case of liver metastases)
- Creatinine lower than 1.5 × ULN.
11. Any patient with childbearing potential (i.e., not surgically sterile or postmenopausal for highert than >1 year) must use highly effective contraceptives with a Pearl index lower than 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 pregnan
1. Refractory to platinum-based chemotherapy (defined as remained progressive or became progressive under any previous platinum-based regimen).
2. Treatment-free interval of more than 12 months after the most recent antecedent platinum-based chemotherapy regimen.
3. Concomitant anti-tumor therapy or immunotherapy.
4. Treatment with monoclonal antibodies or investigational agents maximum 30 days before randomization (Note: prior anti-MUC1 therapy is not permitted at any time).
5. Limited field radiotherapy maximum 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).
6. Prior allergic reaction to a monoclonal antibody, grade 3 infusion related reaction (IRR) or any grade 4 reaction to a monoclonal antibody.
7. Known sensitivity to any component of the test product.
8. Contraindication to the premedications used in this study (paracetamol/acetaminophen, H1 and/or H2 receptor antagonists, and steroids).
9. Clinical evidence of brain metastasis or leptomeningeal involvement.
10. Primary or secondary immune deficiency.
11. Clinically active infections grade higher than 2 using NCI CTCAE v4.0.
12. Active hepatitis B or C or infection with human immunodeficiency virus (HIV).
13. Myocardial infarction within 6 months prior to Screening.
14. 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.
15. Prior or planned major surgery within 30 days prior to randomization and/or incomplete recovery from prior surgery.
16. 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).
17. Active drug or alcohol abuse.
18. 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.
19. Pregnancy or lactation.
20. Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons.
21. Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous PankoMab-GEXTM administration.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method