Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004829

Trial Description

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Title

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

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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 AMG 386 or AMG 386 Placebo in combination
with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004829
  •   2013/05/07
  •   2011/09/29
  •   no
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Secondary IDs

  •   NCT01493505  (ClinicalTrials.gov)
  •   20101129  (Amgen)
  •   TRINOVA-3 20101129/ENGOT-ov2 
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Health Condition or Problem studied

  •   Fallopian Tube Cancer
  •   Ovarian Cancer
  •   Peritoneal Cancer
  •   C56 -  Malignant neoplasm of ovary
  •   C57.0 -  Malignant neoplasm: Fallopian tube
  •   C48.1 -  Malignant neoplasm: Specified parts of peritoneum
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Interventions/Observational Groups

  •   Drug: AMG 386
  •   Drug: Paclitaxel
  •   Drug: AMG 386 Placebo
  •   Drug: Carboplatin
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist
  •   Placebo, Active control
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Progression free survival; time frame: 3 years

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Secondary Outcome

- Overall survival (OS); time frame: 5 years
- Incidence of adverse events and significant laboratory abnormalities; time frame: 4 years
- Pharmacokinetics of AMG 386 (Cmax and Cmin); time frame: 1 year; pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
- Incidence of anti-AMG 386 antibody formation; time frame: 4 years; pre-dose weeks 1, 10, 19
- Patient reported ovarian cancer-specific symptoms and health related quality of life; time frame: 4 years
- Patient reported status as measured by the EuroQOL (EQ-5D); time frame: 4 years
- AMG 386 exposure-response relationships for PFS and OS; time frame: 4 years
- Correlation of serum biomarkers with measures of response; time frame: 4 years

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Countries of Recruitment

  •   United States
  •   Austria
  •   Belgium
  •   Canada
  •   Denmark
  •   Germany
  •   Greece
  •   Hong Kong
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Netherlands
  •   Russian Federation
  •   Spain
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Locations of Recruitment

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Recruitment

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  •   2012/01/31
  •   2000
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian,
primary peritoneal or fallopian tube cancer with an indication for first-line
treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma,
mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma,
mucinous or neuroendocrine histology are excluded

- Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian,
primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization

- Subjects with FIGO Stage IIIC or IV disease must either:

- Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer
within 12 weeks prior to randomization or

- Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG
386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian
tube cancer

- ECOG performance status of 0 or 1

- Adequate bone marrow, renal and hepatic function

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Exclusion Criteria

- Prior use of any anticancer therapy or experimental therapy for epithelial ovarian,
primary peritoneal or fallopian tube cancer

- Previous abdominal and/or pelvic external beam radiotherapy

- History of central nervous metastasis

- History of arterial or venous thromboembolism within 12 months prior to randomization

- Clinically significant cardiovascular disease within 12 months prior to randomization

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Addresses

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    • Amgen
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    • Amgen
    • MD 
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    • Amgen
    • MD 
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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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Status

  •   Recruiting complete, follow-up continuing
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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 .
  •   8
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.