Study on the Safety and Effects of LY2880070 and Gemcitabine in Patients with Advanced or Metastatic Cancer, Focusing on Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying treatments for advanced or metastatic cancer, with a particular focus on ovarian cancer. The study will evaluate the safety and effectiveness of a new treatment called LY2880070, both on its own and in combination with another medication called gemcitabine. Gemcitabine is a medication that is often used in cancer treatment and is given as an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to assess how well patients tolerate the combination of LY2880070 and gemcitabine. Participants in the study will receive either the new treatment alone or in combination with gemcitabine. Some participants may receive a placebo, which is a substance with no active medication. The study will monitor patients over a period of time to observe any side effects and to see how the cancer responds to the treatment.

Throughout the study, patients will have regular check-ups and tests to ensure their safety and to track the progress of their treatment. The study aims to provide valuable information on the potential benefits and risks of using LY2880070, especially for patients with BRCA1/2 wild-type high-grade serous ovarian carcinoma, a specific type of ovarian cancer. This research could lead to new treatment options for patients with these advanced forms of cancer.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, medical staff will review your medical history and perform a physical examination to ensure you meet the study requirements.

You will be informed about the study procedures, and any questions you have will be answered. You will also provide written consent to participate in the study.

2 treatment phase

The treatment phase involves receiving the study medications. You will be given gemcitabine and LY2880070 as part of the study.

Gemcitabine will be administered intravenously, which means it will be given through a vein. The dosage and frequency will be determined by the study team based on your specific condition.

LY2880070 will be administered as a capsule that you will swallow. The dosage and frequency will also be determined by the study team.

3 monitoring and follow-up

Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. This will include blood tests, imaging tests, and other assessments as needed.

The study team will closely monitor for any side effects or changes in your condition. You will be asked to report any new symptoms or concerns you may have.

4 end of study

At the end of the study, you will have a final visit where your overall health and response to the treatment will be evaluated.

The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who Can Join the Study?

Patients must be 18 years or older.
Patients must be able to walk and perform daily activities with minimal assistance.
Patients must have a life expectancy of at least 12 weeks.
Patients must be able to swallow capsules.
Patients must have adequate organ function:
- Blood health: Enough white blood cells, platelets, and hemoglobin.
- Liver health: Acceptable levels of bilirubin, ALT, and AST.
- Kidney health: Sufficient filtration rate.
Patients must have stopped certain cancer treatments and therapies at least 21 days before joining the study.
Patients must have stopped using certain drugs that affect liver enzymes at least 5 half-lives before joining the study.
Patients must have recovered from any side effects of previous treatments, except for mild hair loss or nerve damage.
Patients must have received 2 to 4 previous treatments for advanced or metastatic disease, with at least one being platinum-based.
Patients who had major surgery must be fully recovered and at least 4 weeks post-surgery before joining the study.
Patients who can have children must agree to use highly effective birth control during the study and for 6 months after the last dose.
All females who can have children must have a negative pregnancy test before starting the study treatment.
Patients must have progressive disease after their last treatment and measurable tumor lesions.
Patients must be considered suitable for experimental therapy by the investigator.
Patients must have a specific type of ovarian cancer and meet additional criteria related to previous treatments and genetic testing.

Who Cannot Join the Study?

Patients with any other type of cancer besides advanced or metastatic cancer cannot participate. Metastatic cancer means the cancer has spread to other parts of the body.
Only female patients can participate. Male patients are not eligible.
Patients who are considered part of a vulnerable population are not eligible. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland

Other Sites

Site Name	City	Country
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Opca Bolnica Zadar	Zadar	Croatia
KBC Zagreb	Zagreb	Croatia
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Uptcsbrqcvdbcp Cblyczb Kyrkyvdxf	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Croatia	Not recruiting	01.06.2023
Poland	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

LY2880070 is an experimental medication being tested to see if it can help treat advanced or metastatic cancer, particularly ovarian cancer. It is being studied to understand how safe it is for patients and how well it works when used alone or with another medication. This medication is still in the early stages of research, so doctors are trying to learn more about its effects and how it might help people with cancer.

Gemcitabine is a medication that is already used to treat various types of cancer. It works by slowing or stopping the growth of cancer cells. In this clinical trial, Gemcitabine is being used in combination with LY2880070 to see if the two medications together can be more effective in treating ovarian cancer. Researchers are looking at how well this combination works and how safe it is for patients.

Investigated diseases:

Advanced or Metastatic Cancer – This condition refers to cancer that has spread from its original site to other parts of the body. It occurs when cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system. As the disease progresses, these cells form new tumors in other organs or tissues. The spread of cancer can affect various body systems, leading to a range of symptoms depending on the organs involved. The progression of metastatic cancer can vary widely depending on the type of cancer and the individual. It is characterized by the continuous growth and spread of cancer cells, which can lead to increased symptoms and complications over time.

Trial ID:

2023-503459-91-00

Protocol code:

ESPS-001(m)

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of LY2880070 and Gemcitabine in Patients with Advanced or Metastatic Cancer, Focusing on Ovarian Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?