Phase 2 Kidney Cancer Trial, Terminated NCT01545817 Sponsor: Novartis Pharmaceuticals Condition: Kidney 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 enrolled 74 people who first received a medicine called pazopanib, and 38 of those people then went on to receive a second medicine called everolimus. The trial was looking at how long patients went without their disease getting worse (called "progression-free survival"), as well as how long patients lived overall, and whether tumours shrank during treatment. The reported data shows that for patients on the second medicine (everolimus), the midpoint time before the disease progressed or death occurred was 5.1 months. When looking at survival probability at specific time points during everolimus treatment, the reported figures show that approximately 73.7% of patients had not experienced progression at 3 months, and approximately 35.5% had not at 6 months. For tumour response during everolimus treatment, 0% of patients had a complete disappearance of tumours, while 7.9% had tumours shrink by at least 30%. During the earlier pazopanib treatment period, the reported data shows 6.8% had complete disappearance and 39.2% had tumours shrink by at least 30%. The reported data also shows that from the time patients started everolimus, the midpoint survival time was 15.6 months. For patients who received both medicines in sequence, the midpoint survival time from the very start of treatment (pazopanib) was reported as 35.7 months. It is worth noting that in both treatment periods, 0 participants were recorded as having "completed" the study, meaning all participants either progressed, withdrew, or were otherwise recorded as not completing — the data does not provide a fuller breakdown of these reasons. 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 Kidney Cancer Trial, Terminated

NCT01545817
Terminated Phase 2 🇦🇺 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 are 18 years of age or older
  • You have been diagnosed with a type of kidney cancer called clear-cell renal cell carcinoma (RCC), confirmed by a lab test on a tissue sample
  • Your kidney cancer has spread to nearby areas or to other parts of your body
  • You have at least one tumor that can be measured on a CT scan or MRI
  • You have not had any previous systemic (whole-body) treatment for your advanced or metastatic kidney cancer
  • You are reasonably able to carry out daily activities (confirm with trial site for exact fitness level required)
  • Your liver, kidneys, and other organs are working well enough (confirm with trial site for exact requirements)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test and agree to use reliable contraception during the study
  • If you are a man with a female partner who could become pregnant, you must have had a vasectomy or agree to use effective contraception starting 2 weeks before treatment and for a period after the last dose
  • You are able to swallow tablets and do not have significant stomach or bowel problems that would prevent you from absorbing the medication

Additional requirements if moving on to the second treatment (everolimus):

  • Your cancer must have gotten worse within 6 months of stopping the first treatment (pazopanib)
  • You still have at least one measurable tumor at the start of the second treatment
  • If your cancer spread to the brain during the first treatment, you must have no symptoms, be neurologically stable, not need steroids for brain symptoms, and not have needed certain seizure medications in the 4 weeks before starting everolimus

Who may not be able to join:

  • You are currently breastfeeding
  • You have had another type of cancer in the past, unless you have been cancer-free for 3 or more years, or had certain types of skin cancer or early-stage cancer that were fully treated
  • You currently have brain metastases (cancer spread to the brain) causing symptoms
  • You have significant stomach or bowel problems that could affect how you absorb medication
  • You have serious liver disease (confirm with trial site for exact classification)
  • You are currently taking regular steroid medications or other drugs that suppress your immune system
  • You have active bleeding, a tendency to bleed easily, or are taking blood-thinning medication (except very low-dose coumadin)
  • You have an abnormal heart rhythm reading on an ECG (confirm with trial site for exact measurement)
  • You have a serious uncontrolled medical condition or active infection
  • Your blood pressure is not well controlled (roughly 140/90 mmHg or higher)
  • You have had a heart attack, unstable chest pain, a stroke, or a blood clot in the lungs within the past 6–12 months
  • You have lesions in or around the major blood vessels in your lungs that could increase the risk of bleeding
  • The trial doctor does not feel the second treatment period is appropriate for you based on your overall health or other reasons

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 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.
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: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Australian sites

Novartis Investigative Site, Garran, Australian Capital Territory
Novartis Investigative Site, Kogarah, New South Wales
Novartis Investigative Site, Auchenflower, Queensland
Novartis Investigative Site, Southport, Queensland
Novartis Investigative Site, Elizabeth Vale, South Australia
Novartis Investigative Site, Kurralta Park, South Australia
Novartis Investigative Site, Woodville, South Australia
Novartis Investigative Site, Footscay, Victoria
Novartis Investigative Site, Frankston, Victoria
Novartis Investigative Site, Nedlands, Western Australia
Novartis Investigative Site, Perth, Western Australia

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

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
19 April 2012
Est. completion
18 November 2016

Where this trial is recruiting

🇦🇺 Australia 🇰🇷 South Korea

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

Primary endpoints

Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST

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