Phase 3 Ovarian Cancer Trial, Completed NCT01846611 Sponsor: Janssen Research & Development, LLC 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 (NCT01846611) involved 576 people in total — 289 who were assigned to receive a combination of trabectedin and DOXIL (a chemotherapy medicine), and 287 who received DOXIL alone. The trial was measuring how long participants lived overall, how long they lived before their cancer got worse, and how many participants saw their tumours shrink or disappear. The reported data shows that, for overall survival (how long participants lived from the start of the trial), the trabectedin-plus-DOXIL group had a reported median of 23.82 months, compared with 22.21 months for the DOXIL-alone group. (Median means half the participants in each group lived longer than that figure, and half did not reach it.) For progression-free survival (the time before the cancer got worse or a participant died), the reported median was 7.52 months in the combination group and 7.26 months in the DOXIL-alone group. For the objective response rate — meaning the percentage of participants whose tumours shrank significantly or disappeared entirely — the reported figures were 46.0% in the combination group and 35.9% in the DOXIL-alone group. 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 3 Ovarian Cancer Trial, Completed

NCT01846611
Completed Phase 3 🇦🇺 Australian site

Who may 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 might be able to join this trial:

  • You have been diagnosed with advanced or relapsed ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has been confirmed by a tissue sample (biopsy).
  • You are generally well enough to carry out everyday activities with little or no limitation (confirm with trial site for exact fitness level required).
  • You received your first cancer treatment with a platinum-based chemotherapy, and your cancer did not get worse for at least 6 months after finishing it.
  • You received a second round of platinum-based chemotherapy, and your cancer responded but then came back.
  • Scans have shown your cancer has grown or spread after that second treatment (special timing rules apply if your second treatment included a drug called pegylated liposomal doxorubicin — confirm with trial site).
  • Your cancer can be measured on scans at the start of the study.
  • Your BRCA gene mutation status (a specific genetic test result) is known, or you are willing to have a blood test to find out before joining.
  • Your recent blood test results are within acceptable ranges set by the study.
  • Your heart is pumping normally, as shown by a special heart scan.
  • Any side effects from your previous treatment (except hair loss) have mostly settled down before you join.
  • You have a negative pregnancy test at the start of the study.
  • You agree to use effective contraception as required by the study.

Who may not be able to join:

  • Your ovarian cancer has been identified as a specific type called "mucinous" ovarian cancer.
  • You have had more than 2 previous courses of cancer treatment (note: maintenance therapies and hormonal therapies do not count toward this total — confirm with trial site).
  • You have previously been treated with doxorubicin or similar drugs (called anthracyclines) at a total dose above a certain level (confirm with trial site for exact details).
  • You are currently pregnant or breastfeeding.
  • You have received radiation therapy, chemotherapy, experimental therapy, hormonal therapy, or biological therapy within the 3 weeks before starting this study, or you are currently taking part in another clinical trial.
  • You have had another type of cancer in the past, unless it was a minor skin cancer or early-stage cervical cancer that was fully treated, or unless you have been in remission for 5 or more years.
  • You have a known allergy or bad reaction to the study drugs (Doxil or dexamethasone) or their ingredients.
  • Your cancer has spread to your brain or central nervous system.
  • You have significant long-term liver disease, such as cirrhosis or active hepatitis requiring antiviral treatment.
  • You have had a heart attack in the last 6 months, moderate-to-severe heart failure, uncontrolled chest pain, serious heart rhythm problems, or other significant heart conditions.
  • You have certain ongoing medical conditions, including uncontrolled diabetes, a psychiatric condition that would make it hard to follow the study rules, uncontrolled seizures, a newly diagnosed blood clot in a vein, or an active serious infection.
  • Your doctor feels that any other health condition could put you at risk or prevent you from safely taking part in the 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.

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 28 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Australian sites

, Adelaide,
, Ballarat,
, Brisbane,
, Gosford,
, Parkville,
, Subiaco,
, Toorak Gardens,
, Townsville,
, Wodonga,
, Woodville,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
16 October 2013
Est. completion
18 January 2018

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇮🇱 Israel 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇺 Russia 🇿🇦 South Africa 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Overall Survival (OS)

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: 28 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