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

NCT01113957

NCT01113957
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with recurrent high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by a tissue or cell sample.
  • You have had at least 1 chemotherapy treatment containing platinum, and no more than 3 chemotherapy treatments in total over the last 5 years (certain other treatments like targeted therapies, hormonal treatments, or immunotherapy do not count toward this limit).
  • Your cancer has either stopped responding to platinum-based chemotherapy, or you are unable to tolerate platinum-based chemotherapy due to toxicity or a documented allergy, and it has been more than 3 months since your last platinum treatment.
  • You are considered eligible to receive a chemotherapy drug called PLD (pegylated liposomal doxorubicin).
  • Your cancer can be measured on a CT scan, OR you have a raised blood level of a marker called CA-125 that meets specific criteria.
  • You are reasonably active and able to care for yourself (a general health score of 0–2 on a standard scale used by doctors).
  • Your blood counts, kidney function, and liver function meet the required levels based on recent blood tests.
  • If you could become pregnant, you agree to use adequate contraception during the study and for 90 days after, and you have a negative pregnancy test before starting treatment.

Who may not be able to join:

  • You have previously been treated with a type of drug called a PARP inhibitor (except for a single dose in one specific early-phase study).
  • You have had a serious allergic reaction to doxorubicin or to any component of PLD in the past.
  • You have received any cancer treatment or experimental drug within the past 28 days, or you have not yet recovered sufficiently from side effects of previous cancer treatment.
  • You have had major surgery within the past 28 days.
  • You have previously had radiation therapy to the abdomen or pelvis, unless it was to treat ovarian, fallopian tube, or primary peritoneal cancer, and certain additional conditions are not met (confirm with trial site).
  • You have a known history of cancer that has spread to the brain.
  • You have a serious uncontrolled medical condition, such as an active uncontrolled infection, heart failure, unstable chest pain or irregular heartbeat, or a psychiatric or social situation that would make it difficult to follow the study requirements.
  • You are currently pregnant or breastfeeding.
  • You require feeding through a tube or an IV line for nutrition, or you have signs of a bowel blockage or bowel perforation.
  • You have had another active cancer within the past 5 years, with the exception of certain skin cancers or cancers considered fully cured (confirm with trial site).

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
AbbVie (prior sponsor, Abbott)
Registry
clinicaltrials_gov
Start date
1 March 2010
Est. completion
1 June 2013

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇭🇺 Hungary 🇮🇱 Israel 🇳🇿 New Zealand 🇵🇱 Poland 🇬🇧 United Kingdom 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Objective response rate between the two treatment arms (ABT-888 + temozolomide versus the PLD) will be based on tumor measurements and CA-125 levels.

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