Phase 2 Ovarian Cancer Trial, Terminated NCT00522301 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Ovarian Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial involved 6 participants who were all given an oral medicine called sorafenib (also known as BAY43-9006). The trial was set up to measure what is called "progression-free survival rate at 12 months" — in plain terms, this means the researchers wanted to track how many participants went 12 months without their condition getting worse. The reported data shows that none of the 6 participants completed the trial. According to the results, 5 of the participants developed a rash, and as a result those 5 participants either were advised to leave the trial or chose to leave themselves. Because of this, the primary goal of the trial — tracking participants over 12 months — was not able to be met, and no numerical results for that outcome were reported. The data does not include any further detail about what happened to the sixth participant, or any secondary outcome measurements. The reported data shows this trial was stopped very early and did not produce the outcome figures it originally set out to collect. No conclusions about how the medicine performed over time can be drawn from these results, as the data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Ovarian Cancer Trial, Terminated

NCT00522301
Terminated Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You have been diagnosed with a cancer of the ovary, fallopian tube, or lining of the abdomen (peritoneum), confirmed by a laboratory test, at any stage or grade.
  • You have already had surgery to remove as much tumour as possible, followed by chemotherapy that included at least one platinum-based drug.
  • Your cancer came back after initial treatment, but you then had further chemotherapy and are now in complete remission (no clear signs of cancer remaining).
  • Your CA125 blood marker is at or below 35 units/L, your physical exam is normal, and your most recent CT scan of the abdomen and pelvis shows no definite sign of disease.
  • You are generally well enough to carry out normal activity most of the time (confirm with trial site regarding the specific performance scale used).
  • Your doctors expect you to live for more than 3 months.
  • Your blood counts, kidney function, liver function, and blood clotting results are all within acceptable ranges (the trial team will check these with blood tests).
  • Your urine shows no significant levels of protein (further urine testing may be required if there is a borderline result).
  • Your blood pressure has been stable across three separate readings before starting treatment.
  • You have little or no nerve damage (such as numbness or tingling) in your hands or feet.
  • You are not pregnant or breastfeeding, and you have had a negative pregnancy test.
  • If you are able to become pregnant, you are willing to use effective contraception during the trial.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You have been diagnosed with another serious (invasive) cancer in the past 5 years, other than certain common skin cancers.
  • You have cancer that has spread to the brain.
  • You have an uncontrolled illness such as an active infection, heart failure, unstable chest pain, an irregular heartbeat, or uncontrolled diabetes.
  • You have a mental health condition or personal situation that may make it difficult to follow the trial requirements.
  • Your blood pressure remains too high even after at least two attempts to adjust blood pressure medication (confirm specific thresholds with trial site).
  • You have had a stroke, mini-stroke (TIA), or blood clot event in the past 6 months.
  • You have had a significant bleeding episode in the lungs or elsewhere in the past 4 weeks.
  • You have a wound, ulcer, or bone fracture that is not healing properly.
  • You have a history of abnormal bleeding or blood clotting problems.
  • You are unable to swallow tablets or have a digestive condition that would prevent you from absorbing oral medication properly.
  • You have had a serious allergic reaction to a drug similar to the study drug (sorafenib tosylate).
  • You have previously been treated with sorafenib or similar drugs that target the same biological pathways.
  • You have had major surgery (such as open abdominal surgery) in the past 4 weeks, or minor surgery in the past 2 weeks.
  • You are HIV-positive and currently taking combination antiretroviral therapy.
  • You are currently taking St. John's Wort, rifampin, or certain anti-seizure medications such as carbamazepine, phenytoin, or phenobarbital.
  • You have had radiotherapy within the past 4 weeks, chemotherapy or immunotherapy within the past 3 weeks, or hormonal cancer treatment within the past 1 week.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 July 2007
Est. completion
1 March 2008

Where this trial was run

🇺🇸 United States

These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Progression-free Survival (PFS) Rate at 12 Months

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov