Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003953

Trial Description

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Title

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This research is being done to find out if Carboplatin and Taxane works better alone or when
given with an experimental drug called MORAb-003(farletuzumab) in subjects with first
platinum sensitive relapsed ovarian cancer.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003953
  •   2012/11/30
  •   2009/02/13
  •   no
  •   [---]*
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Secondary IDs

  •   NCT00849667  (clinicaltrials.gov)
  •   MORAb003-004  (Morphotek)
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Health Condition or Problem studied

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

  •   Drug: MORAb-003 (farletuzumab)
  •   Drug: MORAb-003 (farletuzumab)
  •   Drug: 0.9% Saline
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Characteristics

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

- Progression-free survival using by RECIST; time frame: 3 years

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Secondary Outcome

- Overall Survival, CA-125 PFS, GCIG PFS, Length of first versus second remission, Tumor Response,Serologic Response (CA-125), Quality of Life, Resource utilization and PK DDI substudy.; time frame: 4 years

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Canada
  •   Chile
  •   France
  •   Germany
  •   Greece
  •   Hong Kong
  •   Hungary
  •   India
  •   Israel
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Mexico
  •   Netherlands
  •   Philippines
  •   Poland
  •   Portugal
  •   Russian Federation
  •   Singapore
  •   Spain
  •   Switzerland
  •   Taiwan, Province of China
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2009/03/31
  •   1080
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- A histologically or cytologically confirmed diagnosis of non-mucinous epithelial
ovarian cancer including primary peritoneal or fallopian tube malignancies

- Must have measurable disease by CT or MRI scan

- Must have relapsed radiologically with a randomization date within ≥6 and < 24 months
of completion of first-line platinum chemotherapy

- Have been treated with debulking surgery and first-line platinum and taxane based
chemotherapy.

- Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have
been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g.
taxane) or cancer vaccine therapy is allowed.

- Must be a candidate for carboplatin and taxane therapy

- Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

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Exclusion Criteria

- Subjects who never responded to first-line platinum-based therapy or whose first
relapse occurs <6 months or >24 months from the last platinum therapy

- Subjects who have received other therapy to treat their ovarian cancer since relapse

- Known central nervous system (CNS) tumor involvement

- Evidence of other active invasive malignancy requiring treatment in the past 5 years

- Known allergic reaction to a prior monoclonal antibody therapy or have any documented
HAHA

- Previous treatment with MORAb-003 (farletuzumab)

- Clinical contraindications to use of a taxane

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Addresses

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    • Morphotek
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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 complete, follow-up complete
  •   2013/05/01
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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 .
  •   4
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.