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Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

Sponsor
SOTIO a.s. (Industry)
Overall Status
Completed
CT.gov ID
NCT02107950
Collaborator
(none)
71
Enrollment
16
Locations
2
Arms
42.5
Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: DCVAC/OvCa in parallel with chemotherapy
  • Drug: Standard of Care
 Phase 2

Detailed Description

The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
May 17, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: DCVAC/OvCa in parallel with chemotherapy

Combination therapy with DCVAC/OvCa and Standard of Care

Biological: DCVAC/OvCa in parallel with chemotherapy
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
Other Names:
  • DCVAC/OvCa
  • carboplatin and gemcitabine

    		•
    Active Comparator: Standard of Care

    Standard of Care carboplatin and gemcitabine

    Drug: Standard of Care
    Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
    Other Names:
  • Carboplatin and Gemcitabine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determine median progression free survival [72 Week]

    Secondary Outcome Measures

    1. Overall survival (all causes) [56, 64, 72 weeks]

    2. Objective Response Rate [8, 16, 24, 32, 40, 48, 56. 64. 72 weeks]

    3. Biological Progression Free Interval [6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks]

    4. Immunological Response [24, 48, 72 weeks]

    5. Frequency of adverse events [8, 16, 24, 32, 40, 48, 56. 64. 72 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brno Czechia 625 00
    2 Brno Czechia 656 53
    3 Ceske Budejovice Czechia 370 01
    4 Hradec Králové Czechia 500 05
    5 Nový Jičín Czechia 741 01
    6 Olomouc Czechia 755 20
    7 Ostrava Czechia 708 52
    8 Prague Czechia 128 08
    9 Praha 5 Czechia 150 06
    10 Cologne Germany 50931
    11 Dresden Germany 01307
    12 Erlangen Germany 91 054
    13 Bialystok Poland 15-276
    14 Krakow Poland 31-501
    15 Lublin Poland 20-081
    16 Poznan Poland 60-569

    Sponsors and Collaborators

    • SOTIO a.s.

    Investigators

    • Study Director: Ales Horacek, Accord Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SOTIO a.s.
    ClinicalTrials.gov Identifier:
    NCT02107950
    Other Study ID Numbers:
    • SOV02
    • 2013-001323-38
    First Posted:
    Apr 8, 2014
    Last Update Posted:
    Aug 15, 2018
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by SOTIO a.s.
    Ovarian
    Platinum Sensitive
    Epithelial
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Hypersensitivity
    Gemcitabine
    Carboplatin

    Study Results

    No Results Posted as of Aug 15, 2018