Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Inavolisib in Combination with Paclitaxel in Patients with Locally Advanced or Metastatic Solid Tumors

This research is testing a new drug called Inavolisib when given alongside an existing chemotherapy drug, Paclitaxel. It's for adults who have solid tumours that have spread or are advanced. The main goals are to check if this new combination treatment is safe and if people can tolerate it well. Researchers will also look at how the body processes the new medicine and if it shows any signs of shrinking tumours. This is an early-stage study, meaning it's one of the first times this combination is being tested in people. It's an important step in learning more about potential new treatments for cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

12 Jun 2024

Locally Advanced or Metastatic Solid Tumors

What is this study about?

This study is looking into a new treatment approach for people who have solid tumours that have either spread to other parts of the body (metastatic) or are in an advanced stage (locally advanced). Solid tumours are abnormal growths of tissue, such as those found in breast, lung, or bowel cancer, rather than blood cancers like leukaemia.

In this study, doctors are combining a new investigational drug called Inavolisib with a commonly used chemotherapy drug called Paclitaxel. The main aim is to understand how safe this new combination is for patients and how well their bodies handle it. They will also be tracking how the new medicine moves through the body and how long it stays there. Importantly, even at this early stage, researchers will be carefully checking if the treatment shows any signs of making tumours smaller or stopping them from growing.

Because this is an early-stage study (called a Phase I trial), it's one of the first times this new combination is being tested in humans. Studies like this are crucial because they help doctors learn important information about new medicines. This knowledge is then used to decide if a treatment should be studied further in larger groups of people, hopefully leading to new and more effective cancer treatments in the future.

Key takeaways

This study is testing a new cancer medicine (Inavolisib) with an existing chemotherapy (Paclitaxel).
It's for adults with advanced or spread solid tumours.
The main goals are to check safety and how the body handles the new combination.
Researchers will also look for early signs the treatment is helping to shrink tumours.
This is an early-stage study, crucial for gathering initial information.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults are also welcome to be considered.

Both men and women are able to take part in this research. The study is specifically looking for people who have solid tumours that are either locally advanced (meaning they have grown into nearby tissues but haven't spread far) or have spread to other parts of the body (metastatic).

There will be other detailed health checks and medical requirements that your study doctor will discuss with you to make sure the study is a good fit and safe for you.

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.

Are you 18 years old or older?
Do you have a diagnosis of a solid tumour?
Has your cancer been described as 'locally advanced' or 'metastatic' (spread)?
Are you able to commit to regular hospital visits and health monitoring?
Are you considering a new treatment option for your cancer?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have various assessments such as blood tests, physical examinations, and scans to monitor your health and the effects of the treatment. You would receive the study medication, Inavolisib, in combination with Paclitaxel, according to a specific schedule decided by the study doctors. The total duration of your participation would depend on how your body responds to the treatment and the study's protocol, but typically involves continued treatment unless side effects become unmanageable or your cancer progresses. There would also be follow-up appointments after you stop active treatment to continue monitoring your health.

Potential risks and benefits

Participating in this study might offer a chance to receive a new treatment that isn't widely available yet, which could potentially help with your cancer, although there's no guarantee of benefit. However, like all medicines, the study drugs may cause side effects, some of which could be serious. Your doctors will carefully monitor you for any side effects and manage them as best they can. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark
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Unverified
Spain
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Unverified
France

Common questions

What is a 'solid tumour'?

A solid tumour is a lump or mass of tissue that doesn't usually contain cysts or liquid areas. Many common cancers, like breast, lung, or bowel cancer, start as solid tumours.

What does 'locally advanced' or 'metastatic' mean?

'Locally advanced' means the cancer has grown into nearby tissues or lymph nodes but hasn't spread far. 'Metastatic' means the cancer has spread from where it started to other parts of your body.

What is Paclitaxel?

Paclitaxel is a common chemotherapy drug used to treat various types of cancer. It works by stopping cancer cells from growing and dividing.

What is Inavolisib?

Inavolisib is a new investigational drug being tested in this study. It aims to target specific pathways within cancer cells to stop them from growing. It's not yet approved for general use.

Why is this called a Phase I study?

Phase I studies are the first stage of testing a new treatment in a small group of people. The main goals are to check for safety, find the best dose, and understand how the body handles the new medicine.