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

NCT00989131

NCT00989131
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, or fallopian tube cancer, confirmed by a tissue or cell sample test
  • Your cancer came back more than 6 months after finishing your first or second round of treatment, which must have included a platinum-based chemotherapy drug
  • Your CA-125 blood marker level is more than twice the upper normal limit, confirmed on two separate blood tests taken at least one week apart, and you may or may not have measurable tumours
  • You are 18 years of age or older
  • You are reasonably active and able to care for yourself, with only limited restrictions on daily activity (confirm with trial site)
  • Your doctors expect you to live for at least 12 weeks or more
  • Your blood counts (white blood cells, platelets, and haemoglobin/red blood cells) meet the minimum required levels at the start of the trial
  • Your liver is functioning well enough, based on blood tests for liver enzymes and bilirubin
  • Your kidneys are functioning well enough, based on a blood test measuring creatinine levels
  • Your alkaline phosphatase (a liver and bone enzyme) level is within an acceptable range
  • You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

  • You have moderate to severe nerve damage (such as numbness, tingling, or pain in hands or feet)
  • You had surgery due to your cancer getting worse within 4 weeks of either of your CA-125 blood tests
  • You are currently receiving hormone therapy, immunotherapy, or radiotherapy, or it has been less than 4 weeks since you finished any of these treatments
  • You have a blocked bowel at the time of screening
  • Your cancer is of a different type or origin than those listed above
  • You are able to become pregnant and are not using reliable contraception, or you are currently pregnant or breastfeeding
  • You have a history of serious allergic reactions to the study drugs
  • You have an uncontrolled medical condition — such as a heart, lung, or kidney problem, possible cancer spread to the brain, or a mental health condition — that the doctor feels would make it unsafe for you to take the study drugs
  • You have taken part in another clinical drug trial within the 4 weeks before starting this study

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
Oasmia Pharmaceutical AB
Registry
clinicaltrials_gov
Start date
1 February 2009
Est. completion
1 October 2013

Where this trial is recruiting

Belarus 🇧🇪 Belgium 🇧🇬 Bulgaria 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇭🇺 Hungary 🇱🇻 Latvia 🇱🇹 Lithuania 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇸🇰 Slovakia 🇸🇪 Sweden 🇺🇦 Ukraine

Primary endpoints

Progression free survival (PFS).; Change in Area under the curve of CA 125; Incidence and severity of hypersensitivity reactions

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