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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01684878

NCT01684878
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with ovarian cancer, primary peritoneal cancer, and/or fallopian tube cancer (confirmed by lab testing of tissue or cells) that has stopped responding to platinum-based chemotherapy
  • Your cancer cells show low levels of a specific protein marker called HER3 (measured by a lab test)
  • You have at least one area of cancer that can be tracked or measured using scans
  • You are reasonably active and able to carry out daily activities (as measured by a standard health scale — confirm with trial site)
  • Your heart is pumping at least 50% of its normal capacity (confirmed by a heart scan)
  • If you could become pregnant, your pregnancy test must come back negative before joining
  • If you could become pregnant, you must agree to use effective birth control during the trial and for at least 6 months after treatment ends

Who may not be able to join:

  • Your cancer is not the type that starts in the lining of the ovary (non-epithelial tumors)
  • You have a type of ovarian tumor considered "borderline" or low-risk for spreading
  • You have had another type of cancer in the past 5 years that could affect your health outlook (some very minor or easily treated skin or cervical cancers may still be acceptable — confirm with trial site)
  • You have previously been treated with more than 2 different chemotherapy drug combinations
  • You have had radiotherapy (radiation treatment) to your pelvis or abdomen at any point in the past
  • You have an uncontrolled brain or nervous system condition unrelated to your cancer, such as uncontrolled seizures
  • You have significant nerve damage or tingling/numbness in your hands or feet (this applies only to one specific part of the trial — confirm with trial site)
  • Your liver, kidneys, or other organs are not working well enough (confirm with trial site)
  • You have high blood pressure that is not controlled, or another serious heart or blood vessel condition
  • You currently have HIV, or an active hepatitis B or hepatitis C infection
  • You are currently taking steroid medication (such as prednisolone) at a relatively high daily dose — low-dose inhaled steroids (like an asthma inhaler) may be acceptable (confirm with trial site)
  • You have taken part in any other experimental treatment trial within the past 28 days
  • You were previously enrolled in Part 1 of this same trial (applies to Part 2 of the trial only)
  • You are currently taking part in any other clinical trial that involves a treatment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Hoffmann-La Roche
Registry
clinicaltrials_gov
Start date
22 October 2012
Est. completion
30 January 2015

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇴 Norway 🇪🇸 Spain 🇸🇪 Sweden

Primary endpoints

Part 1: Percentage of Participants With Adverse Events (AEs); Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov