Ovarian Neoplasms Clinical Trial
Official title:
A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma
Verified date | January 2016 |
Source | Sotio a.s. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
Status | Completed |
Enrollment | 71 |
Est. completion date | May 17, 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Females 18 years old and older - Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy - Radiologically confirmed relapse after >6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry. - The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study Exclusion Criteria: - FIGO I,II epithelial ovarian cancer - FIGO III, IV clear cells epithelial ovarian cancer - Non-epithelial ovarian cancer - Borderline tumors (tumors of low malignant potential) - Prior or current systemic anti-cancer therapy for ovarian cancer [for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy] except first line Platinum-based chemotherapy (with or without bevacizumab) - Previous radiotherapy to the abdomen and pelvis - Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sotio a.s. |
Czechia, Germany, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine median progression free survival | 72 Week | ||
Secondary | Overall survival (all causes) | 56, 64, 72 weeks | ||
Secondary | Objective Response Rate | 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks | ||
Secondary | Biological Progression Free Interval | 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks | ||
Secondary | Immunological Response | 24, 48, 72 weeks | ||
Secondary | Frequency of adverse events | 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks |
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