Phase 3 Mesothelioma Trial, Completed NCT02709512 Sponsor: Polaris Group Condition: Mesothelioma
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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 looked at a treatment called ADI-PEG 20 combined with standard chemotherapy (pemetrexed and platinum), compared to a placebo (an inactive substitute) plus the same standard chemotherapy. The trial ran in two stages — a Phase 2 portion (87 people in the ADI-PEG 20 group and 89 in the placebo group) and a Phase 3 portion (125 and 124 people respectively). The main things being measured were how many participants' tumours shrank or disappeared (called the "response rate"), and how long participants lived overall ("overall survival"). A secondary measure tracked how long participants went before their disease got worse ("progression-free survival"). The reported data shows that in the response rate measurement, 12 participants in each group had their tumours shrink or disappear. For overall survival, the trial reported a median of approximately 9.30 months in the ADI-PEG 20 group compared to 7.66 months in the placebo group at the final analysis. An earlier mid-trial check reported figures of 9.82 months versus 7.49 months respectively. (Median here simply means the point at which half the participants in each group had passed away and half were still living.) For progression-free survival — the time before the disease got worse — the reported median was 6.24 months in the ADI-PEG 20 group and 5.65 months in the placebo 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 Mesothelioma Trial, Completed

NCT02709512
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 confirmed by a tissue biopsy to have a type of mesothelioma (a cancer affecting the lining of the lungs) that cannot be removed by surgery, and it is either the "biphasic" or "sarcomatoid" type
  • You have not yet received any chemotherapy or immunotherapy treatment for this cancer
  • You are generally well enough to carry out light activity and care for yourself (a doctor will assess your overall fitness level)
  • Your doctors expect you to live for at least 3 more months
  • You are 18 years of age or older (there is no upper age limit)
  • Your cancer can be measured using standard imaging scans
  • You are willing and able to give written consent and can take part in the treatment and follow-up appointments
  • Your blood tests show that your blood, liver, and kidneys are working well enough to take part

Who may not be able to join:

  • You have had radiotherapy (other than for pain relief) within the last two weeks before starting the study treatment
  • You have a history of an unstable heart condition
  • You are still experiencing significant side effects from a previous cancer treatment
  • You have cancer that has spread to your brain or spinal cord and is causing symptoms, unless it has been stable for more than one month after treatment
  • You have recently had major surgery on your chest or abdomen and have not yet fully recovered

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: John S Bomalaski, MD, Polaris Group

Australian sites

Chris O'Brien Lifehouse, Camperdown, New South Wales
Tweed Hospital (NNSW LHD), Tweed Heads, New South Wales
Princess Alexandria Hospital and Health Services, Woolloongabba, Queensland
Southern Adelaide Local Health Network, Inc., Bedford Park, South Australia
Austin Health, Heidelberg, Victoria
Sir Charles Gairdner Hospital, Perth, Western Australia

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
Sponsor
Polaris Group
Registry
ClinicalTrials.gov
Start date
1 August 2017
Est. completion
15 August 2022

Where this trial is recruiting

🇦🇺 Australia 🇮🇹 Italy 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Response Rate; Overall Survival Phase 3 Interim Analysis; Overall 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: 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