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CompletedPhase IIInterventional

A study of pazopanib efficacy and safety in patients with advanced clear-cell renal cell carcinoma and ECOG Performance Status 2 (PaZ02)

This clinical trial is looking at a targeted tablet called pazopanib for adults with advanced clear-cell kidney cancer, which is the most common form of kidney cancer. Many cancer studies only enrol people who feel very fit and active. However, this trial is designed for people who have reduced energy and need to rest for up to half of their waking hours because of their illness. In medical terms, this is called performance status 2. Researchers want to see if pazopanib is safe, tolerable, and helpful for this group of patients, who have not had drug treatment for their kidney cancer before. Everyone taking part receives pazopanib. The study team will track participants closely with regular clinic appointments, routine blood tests, and body scans to check how the tumour responds and manage any side effects.

At a glance

Status
Completed
Phase
Phase II
Sponsor
University of Birmingham
Enrolment target
75
Start
21 Feb 2013
Estimated completion
12 Aug 2016

What is this study about?

Clear-cell renal cell carcinoma is the most common type of kidney cancer. When cancer spreads beyond the kidney to other areas of the body, or cannot be safely removed with surgery, doctors describe it as advanced. In recent years, targeted medications have changed how advanced kidney cancer is treated. Pazopanib is one such drug. It works by blocking chemical signals that cancer cells need to grow and build their own blood supply.

Most clinical trials only accept people who are physically active and feel relatively well. In daily life, however, many people living with advanced cancer experience fatigue, weakness, or other symptoms that mean they need to rest for significant parts of the day. Because these individuals are often left out of trials, doctors have less evidence about how well they cope with targeted treatments.

The PaZ02 study was set up to bridge this gap. It investigates how effective and safe pazopanib is for patients who are coping with lower energy levels and who have not received prior systemic (whole-body) cancer therapies. By taking part, patients help doctors learn how to give better, more tailored care to people with similar health needs in the NHS.

Key takeaways

  • Tests pazopanib in adults with advanced clear-cell kidney cancer.
  • Specifically focuses on patients who feel tired and need to rest during the day.
  • All participants receive the study drug as a daily tablet; there is no placebo.
  • Regular hospital appointments, blood tests, and scans will track your health.
  • Participation is completely voluntary, and you can stop at any time.

Who may be eligible?

To be eligible for this study, you must be 18 years of age or older and have a confirmed diagnosis of advanced or metastatic clear-cell kidney cancer that cannot be cured by surgery. You must also not have received any previous whole-body treatments, such as targeted drugs or chemotherapy, for your kidney cancer.

This trial is specifically looking for people who can still manage their own personal care and stay out of bed for more than half the day, but who feel unable to work and need regular rest. Your doctor will also check that your main organs, including your liver, kidneys, and bone marrow, are working well enough for you to take the medication safely.

You will not be able to join if you are pregnant or breastfeeding (unless you stop breastfeeding before treatment begins). People who have already received drug therapies for kidney cancer or who have certain other serious medical conditions will also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am at least 18 years old.
  2. I have been diagnosed with advanced or metastatic clear-cell kidney cancer.
  3. I have not had any previous drug treatments for my kidney cancer.
  4. I can take care of myself, but need to rest for up to half my waking hours.
  5. I am willing to attend regular hospital visits for check-ups, blood tests, and scans.
Answer every question to see your result.

What does participation involve?

If you join the trial, you will take pazopanib as a tablet by mouth once every day at home. Before starting, you will have baseline health checks, including blood tests, urine tests, and a scan (such as a CT scan) to measure your cancer. During the study, you will visit the hospital clinic regularly for check-ups, blood pressure measurements, and routine blood tests to make sure the treatment is safe for you. You will also have periodic scans every few months to see if the tumour has shrunk or stayed the same. You will usually stay on the study for as long as the treatment continues to help you and any side effects remain manageable. After finishing treatment, the team will continue to check on your health through follow-up reviews.

Potential risks and benefits

Taking part may help shrink your tumour, slow down the growth of the cancer, or ease your symptoms, although there is no guarantee of individual benefit. You will also receive careful, regular medical monitoring from a specialist cancer team. However, pazopanib can cause side effects. Common ones include raised blood pressure, tiredness, diarrhoea, changes in hair or skin colour, and feeling sick. Your doctors will watch you closely and can adjust your dose or offer medications to help with these symptoms. Taking part in this study is entirely voluntary. You can choose to leave at any time, and doing so will never affect your standard NHS care or your relationship with your medical team.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • PaZ02 trials office
    City only
    Birmingham, England

Common questions

Will I receive a dummy drug (placebo)?

No. In this trial, every participant receives the active study medication, pazopanib.

Do I have to pay for the trial treatment?

No. The trial medication is provided free of charge through the hospital. You can also ask the team if help is available for travel costs.

How does pazopanib work?

Pazopanib is a targeted drug that blocks signals cancer cells need to build blood vessels, helping to starve the tumour and slow its growth.

Can I leave the study if I change my mind?

Yes. You have the right to withdraw from the trial at any moment without having to give a reason, and your regular care will continue as normal.

Can I take my usual medications while on this trial?

Some medicines can interact with pazopanib. Your trial doctor will review all your current prescriptions, over-the-counter tablets, and supplements before you begin.

How to find out more

Leyre Navarro-Nuñez

Always speak to your GP or specialist before deciding to take part in a study.

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