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

NCT01644825

NCT01644825
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with ovarian cancer at stage IC, II, III, or IV, confirmed by a tissue or cell sample
  • Your cancer got worse during your first round of chemotherapy, or it came back within 6 months after your last platinum-based chemotherapy treatment
  • Your cancer can be measured or tracked using standard imaging or a specific blood marker (CA-125)
  • You have no lasting nerve damage (such as numbness or tingling) left over from previous chemotherapy
  • You are generally well enough to carry out light daily activities (confirm with trial site)
  • You are between 18 and 75 years old
  • Your doctors expect you to live for at least 3 more months
  • You are able to swallow and keep down tablets or capsules
  • You are willing and able to sign a consent form before any study procedures begin
  • You are able and willing to attend all required treatment visits and follow-up appointments

Who may not be able to join:

  • You have, or have previously had, another type of cancer — except for certain treated skin cancers or a very early-stage cervical condition that is being properly treated
  • You have previously been treated with weekly paclitaxel chemotherapy
  • You have had more than 2 previous rounds of chemotherapy
  • You have a serious heart condition, including heart failure, certain heart rhythm problems, or you have had a heart attack, heart surgery, stenting, or significant heart-related events in the past 6 months
  • Your blood counts are too low — specifically, your red blood cells, white blood cells, or platelets fall below certain levels (confirm exact values with trial site)
  • Your kidneys are not working well enough, or your urine protein levels are too high (confirm with trial site)
  • Your liver is not functioning well, based on certain blood test results being too high (confirm with trial site)
  • Your blood clotting test results are higher than a certain level (confirm with trial site)
  • You are pregnant, breastfeeding, or not using adequate contraception
  • You are taking certain medications that cannot be stopped during the trial (confirm which medications with trial site)
  • You have significant stomach or bowel problems that could affect how your body absorbs oral medication, such as inflammatory bowel disease, a history of bowel perforation, or signs of a bowel blockage
  • You have any other serious or unstable health condition
  • Your heart's electrical activity shows a specific abnormality on an ECG (a QTc interval over 480 ms)
  • You have had a stroke, a blood clot in the lungs, or an untreated blood clot in a vein in the past 6 months
  • You have visible blood in your urine
  • You have had major surgery or a serious injury within the past 30 days
  • Your blood pressure is not well controlled, with readings at or above 140/90 mmHg
  • You still have side effects from previous cancer treatment that are moderate or getting worse
  • You have, or are suspected to have, a condition that causes abnormal bleeding
  • You are unable to travel to the trial centre due to where you live

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 2: approximately ~30% 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 2
Sponsor
National Cancer Institute, Naples
Registry
clinicaltrials_gov
Start date
1 December 2010
Est. completion
1 May 2014

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

progression free survival

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