Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007241

Trial Description

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Title

A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007241
  •   2015/04/29
  •   2014/04/04
  •   no
  •   [---]*
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Secondary IDs

  •   2013-001322-26 
  •   NCT02107937  (ClinicalTrials.gov)
  •   SOV01  (Sotio a.s.)
  •   2013-001322-26 
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Health Condition or Problem studied

  •   Ovarian Neoplasms
  •   Ovarian Epithelial Cancer
  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   Biological: DCVAC/OvCa with Standard of Care
  •   Biological: DCVAC/OvCa sequentially chemotherapy
  •   Drug: Standard of Care
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Overall progression free survival (PFS); time frame: 104 weeks

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Secondary Outcome

- Proportion of patients in remission after first line chemotherapy at 6 months; time frame: 0,10, 18, 30, 42 weeks
- Proportion of patients in remission after first line chemotherapy at 12 months; time frame: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
- Biological progression free interval; time frame: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
- Immunological Response; time frame: 0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks
- Proportion of patients requiring 2nd line chemotherapy; time frame: 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks
- Frequency of Adverse Events; time frame: 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks
- Time to 50 percent survival; time frame: 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks

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Countries of Recruitment

  •   Czech Republic
  •   Germany
  •   Poland
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2013/11/30
  •   90
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Female aged ≥18 years

- Patients with newly diagnosed, histologically confirmed, International Federation of
Gynecology and Obstetrics (FIGO) stage III epithelial ovarian, primary peritoneal or
fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone
initial surgery up to 3 weeks before randomization and are selected to receive first
line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)

- Optimally debulked (zero residuum) or maximal residuum <1cm

- Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2

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Exclusion Criteria

- FIGO I,II,IV epithelial ovarian cancer

- FIGO III clear cells epithelial ovarian cancer

- Non-epithelial ovarian cancer (OvCa), borderline tumors (tumors of low malignant
potential)

- Post-surgery residual disease with lesion(s) >1cm

- Prior or current systemic anti-cancer therapy for ovarian cancer [for example
chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor
therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy]

- Previous or concurrent 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

- Patient co-morbidities:Human immunodeficiency virus (HIV) positive, human
T-lymphotropic virus (HTLV) positive, Active hepatitis B (HBV), active hepatitis C
(HCV), active syphilis

- Evidence of active bacterial, viral or fungal infection requiring systemic treatment

- Clinically significant cardiovascular disease including:

Symptomatic congestive heart failure Unstable angina pectoris Serious cardiac arrhythmia
requiring medication Uncontrolled hypertension Myocardial infarction or ventricular
arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) < 40
percent or serious cardiac conduction system disorders, if a pacemaker is not present

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Sotio a.s.
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    •   [---]*
    •   [---]*
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    • Richard Kapsa 
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    •   : (+420) 2241 74448
    •   [---]*
    •   kapsa at sotio.com
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    • Richard Kapsa 
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    •   : (+420) 2241 74448
    •   [---]*
    •   kapsa at sotio.com
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.