Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 1b/2a Three-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination with Gemcitabine in Patients with Advanced or Metastatic Cancer with a Focus on Ovarian Cancer

This research study is looking into a new medicine called LY2880070. It’s being tested on its own and in combination with an existing cancer drug called gemcitabine. The study is for women who have advanced or metastatic cancer, with a particular focus on ovarian cancer. Researchers want to find out if this new medicine is safe to use and if it can help slow down or shrink the cancer. This is an early stage of testing (Phase II), meaning we are exploring its effects and safety in a larger group of patients after initial safety checks. Your safety is the main focus, alongside exploring how well the treatment works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Esperas Pharma Inc., Esperas Pharma Inc.

Enrolment target

Start

28 Aug 2023

Advanced or Metastatic Cancer

What is this study about?

This study is an exploration into a new medicine called LY2880070. Think of it as a thorough investigation to understand how this new treatment works in people, especially those with advanced or metastatic cancer. 'Advanced' or 'metastatic' means the cancer has spread from where it started to other parts of the body.

The main goal of this particular study is to check the safety of LY2880070. This involves carefully watching for any side effects or changes in your body that happen because of the treatment. Researchers will also look at whether the medicine helps to control the cancer, such as shrinking it or stopping it from growing further. This new medicine might be given on its own, or together with a well-known cancer drug called gemcitabine, which is often used in cancer treatment.

This is an early stage clinical trial, referred to as Phase II. This means that while some initial safety tests have been done, this study helps us learn more about the medicine's effects in a larger group of people. The information gathered will be crucial in deciding if this new medicine has the potential to become a standard treatment for people living with ovarian and other advanced cancers in the future.

Key takeaways

New medicine (LY2880070) for advanced or metastatic cancer.
Focus on women with ovarian cancer.
Testing safety and how well it controls cancer.
May be given alone or with existing drug (gemcitabine).
Early stage (Phase II) research.
Regular health monitoring is key.

Who may be eligible?

This study is specifically looking for women who have advanced or metastatic cancer, which means the cancer has spread. There's a particular interest in women with ovarian cancer.

To join, you must be at least 18 years old. There's no upper age limit, as long as you meet other health requirements.

Because this is an early stage study, participants will need to meet certain other health standards, which the study team will explain. These are in place to make sure that taking part is as safe as possible 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 a woman?
Are you aged 18 or over?
Do you have advanced or metastatic cancer?
Is ovarian cancer part of your diagnosis?
Are you able to attend regular hospital visits for tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the study medicine, LY2880070, and potentially gemcitabine. The study team will explain how and when you'll take these medicines. You'll have regular visits to the clinic so the doctors and nurses can closely monitor your health and how you're responding to the treatment. These visits will involve various tests, such as blood tests, scans, and physical examinations, to check for any side effects and to see if the medicine is affecting your cancer. These check-ups will continue throughout your treatment and likely for a period afterwards to make sure your health is stable. The total time you'll be involved in the study will depend on how you respond to the treatment, but the team will give you a clear idea of the expected duration.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of accessing a new treatment before it's widely available, which might help your cancer. However, as with any medicine, there are potential risks, and you may experience side effects from the study drugs. The research team will explain all known side effects and monitor you very closely. You should also know that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Poland
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Unverified
Croatia

Common questions

What does 'advanced or metastatic cancer' mean?

It means the cancer has spread from where it started to other parts of your body.

What is Phase II of a clinical trial?

It's an early stage where doctors are exploring the safety and effectiveness of a new medicine in a larger group of patients after initial safety checks.

Will I definitely receive the new medicine?

Yes, all participants in this open-label study will receive the new medicine, either on its own or with gemcitabine.

How often will I need to visit the hospital?

You'll have regular visits for monitoring, but the exact schedule will be explained by the study team.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect your ongoing medical care.