All studies
CompletedPhase IIInterventional

A study of pazopanib in metastatic merkel cell carcinoma

Merkel cell carcinoma is a rare and fast-growing type of skin cancer. When this cancer spreads to other parts of the body or cannot be completely removed with surgery or controlled with radiotherapy, there are very few standard treatments available. This Phase II clinical trial is investigating whether a targeted medicine called pazopanib can help. Pazopanib works by blocking the signals and blood vessels that cancer cells need to grow. The trial aims to find out how well pazopanib works to control the cancer and what side effects it might cause. It is open to adults who have already received chemotherapy or who are not well enough to have standard chemotherapy. By taking part, patients help doctors understand if pazopanib could become a useful new treatment option for people facing this uncommon and difficult-to-treat cancer.

At a glance

Status
Completed
Phase
Phase II
Sponsor
University of Birmingham (UK)
Enrolment target
25
Start
21 Dec 2012
Estimated completion
21 Dec 2015

What is this study about?

Merkel cell carcinoma is an uncommon type of skin cancer that usually begins as a firm, painless lump on sun-exposed skin. In some cases, the cancer can spread to other areas of the body, which doctors call metastatic cancer. When it has spread or cannot be safely removed with surgery, finding an effective treatment can be challenging because standard options are quite limited.

This study is testing a drug named pazopanib. Pazopanib is a targeted therapy, which means it works differently from traditional chemotherapy. It is designed to stop cancer cells from forming new blood vessels. Without a fresh blood supply, tumours struggle to get the oxygen and nutrients they need to grow and spread.

Researchers want to see if taking pazopanib can shrink these tumours or stop them from growing for a period of time. They will also look closely at how safe the drug is and how well patients tolerate it. Research like this is vital because discovering new, effective treatments can offer better options and hope for people living with advanced Merkel cell carcinoma in the future.

Key takeaways

  • Tests pazopanib, a daily targeted tablet, for advanced Merkel cell carcinoma.
  • Aimed at adults whose cancer has spread or cannot be removed by surgery.
  • Open to patients who have had chemotherapy before or cannot have standard chemotherapy.
  • All participants receive the study drug; there is no placebo.
  • Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

This trial is for adults aged 18 and over who have been diagnosed with Merkel cell carcinoma that has spread (metastatic) or cannot be treated with surgery or radiotherapy. To take part, patients must have tumours that can be measured on a scan so doctors can check if the treatment is working.

Participants must have already tried standard chemotherapy, or their doctor must feel that standard chemotherapy is not suitable for them. Patients also need to be reasonably active and able to look after themselves, meaning they can manage daily activities even if they cannot work.

Because pazopanib is processed by the body, participants must have good enough liver, kidney, and bone marrow function. Routine blood and urine tests will be done before joining to make sure it is safe for the person to take this medicine.

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 aged 18 or older.
  2. I have confirmed Merkel cell carcinoma that has spread or cannot be operated on.
  3. I have measurable cancer that can be tracked on a scan.
  4. I have either had chemotherapy before, or my doctor says chemotherapy is not right for me.
  5. I am well enough to walk around and care for myself during the day.
Answer every question to see your result.

What does participation involve?

If you take part, you will be given pazopanib to take as tablets by mouth once a day at home. Before starting, and regularly during the trial, you will visit the hospital for health checks. These visits will include physical examinations, blood tests, urine tests, and heart checks like blood pressure monitoring. You will also have regular imaging scans, such as CT or MRI scans, to see how your cancer is responding to the medicine.

You will continue taking the treatment for as long as it is helping you and the side effects are manageable. If the cancer begins to grow again or if the side effects become too troublesome, the study treatment will stop. Afterwards, the study team will continue to keep in touch with you to monitor your health and recovery.

Potential risks and benefits

The possible benefit of taking part is that pazopanib may help to shrink your cancer or slow its growth, although this cannot be guaranteed. Your involvement will also help doctors learn more about treating this rare cancer. However, all cancer medicines carry a risk of side effects. Common side effects of pazopanib can include high blood pressure, tiredness, diarrhoea, feeling sick, and changes in how your liver works. Your medical team will monitor you very closely and can adjust your dose or give supportive treatments if needed. Taking part is completely voluntary, and you are free to leave the trial at any point without it affecting your standard NHS care.

Locations (1)

  • University of Birmingham
    Approximate
    Birmingham, England

Common questions

How is pazopanib taken?

Pazopanib comes in tablet form, which you swallow once a day at home on an empty stomach.

Will I receive a dummy drug (placebo)?

No. In this Phase II study, every person who joins the trial will receive the active study medicine, pazopanib.

Do I have to pay for the study treatment?

No, the trial medicine and any extra study tests are provided free of charge.

What happens if I experience difficult side effects?

Your doctor can lower your dose, pause your treatment, or prescribe medicines to manage side effects. If necessary, you can stop the trial drug altogether.

Can I leave the trial if I change my mind?

Yes, you can leave the study at any time without giving a reason, and your regular medical team will continue to care for you.

How to find out more

Claire Gaunt

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

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