Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007748

Trial Description

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Title

A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo
plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo
plus PLD in women with recurrent partially platinum sensitive or resistant epithelial
ovarian, primary peritoneal or fallopian tube cancer.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007748
  •   2015/01/30
  •   2011/01/20
  •   no
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Secondary IDs

  •   2009-017946-30 
  •   NCT01281254  (ClinicalTrials.gov)
  •   20060517  (Amgen)
  •   2009-017946-30 
  •   ENGOT-ov-6 
  •   TRINOVA-2 
  •   20060517 
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Health Condition or Problem studied

  •   Fallopian Tube Cancer
  •   Ovarian Cancer
  •   Primary Peritoneal Cancer
  •   C56 -  Malignant neoplasm of ovary
  •   C57.0 -  Malignant neoplasm: Fallopian tube
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Interventions/Observational Groups

  •   Drug: AMG386 plus PLD
  •   Drug: Placebo plus PLD
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Characteristics

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

- To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications; time frame: Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.

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Secondary Outcome

- • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival; time frame: weekly

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Denmark
  •   France
  •   Germany
  •   Hong Kong
  •   Hungary
  •   Italy
  •   New Zealand
  •   Poland
  •   Singapore
  •   Slovakia
  •   Switzerland
  •   Taiwan, Province of China
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2011/03/31
  •   223
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Histologically or cytologically documented invasive epithelial ovarian, primary
peritoneal, or fallopian tube cancer

- Radiographically documented disease progression either on or following the last dose
of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube
cancer

- Subjects must have had one prior platinum-based chemotherapeutic regimen for
management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound.

- Female 18 years of age or older at the time the written informed consent is obtained

- Adequate organ and hematological function

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Exclusion Criteria

- Subjects who have received more than 3 previous regimens of anti cancer therapy for
epithelial ovarian, primary peritoneal or fallopian tube cancer

- Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any
anthracycline-based or mitoxantrone-based chemotherapy

- Subjects with primary platinum-refractory disease

- Subjects with platinum-free interval (PFI) > 12 months from their last platinum based
therapy

- History of central nervous system metastasis

- Major surgery within 28 days prior to randomization or still recovering from prior
surgery

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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 .
  •   2
  •   2015/01/22
* This entry means the parameter is not applicable or has not been set.