Study of Elraglusib Alone or with Chemotherapy for Patients with Refractory Blood Cancers or Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for patients with certain types of cancer. The study involves patients with refractory hematologic malignancies or solid tumors, which are types of cancers that have not responded to previous treatments. The treatment being tested is an investigational drug called 9-ING-41, which is given as an injection. This drug works by inhibiting a protein known as Glycogen Synthase Kinase-3 Beta (GSK-3β), which may help in controlling cancer growth.

The purpose of the study is to determine the 1-year survival rate of patients treated with 9-ING-41 compared to those who do not receive this treatment. The study will explore how well the drug works when used alone or in combination with other chemotherapy drugs. Patients will receive the treatment through intravenous administration, which means the drug is delivered directly into the bloodstream through a vein. The study will monitor patients over time to see how their cancer responds to the treatment and to check for any side effects.

Throughout the study, researchers will collect information on various outcomes, such as how long patients live without their cancer getting worse, the overall survival time, and any changes in the size of the tumors. The study will also look at the disease control rate, which includes patients whose cancer remains stable or shows improvement. By participating in this study, researchers hope to gather valuable data that could lead to new treatment options for patients with these challenging types of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

A pregnancy test is required for women of childbearing potential within 72 hours before starting the study therapy.

2 treatment initiation

The study involves the administration of 9-ING-41, which is given as an intravenous injection. This means the medication is delivered directly into a vein.

The specific schedule for administering 9-ING-41 is determined during the initial phase of the study.

3 treatment monitoring

Regular monitoring is conducted to assess the response to the treatment. This includes scheduled visits, laboratory tests, and imaging studies such as CT scans or MRIs.

The primary goal is to evaluate the 1-year survival rate and other outcomes like disease control and response rates.

4 adverse event monitoring

Any side effects or adverse events are closely monitored from the first administration of 9-ING-41 until 30 days after the final dose.

The monitoring follows the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

5 completion of treatment

The study is estimated to conclude by December 31, 2025. Upon completion, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

The patient must be able to understand and willingly sign a written consent form, agreeing to follow the study’s requirements, including visits, treatment plans, and tests.
Women who can have children must have a negative pregnancy test before starting the study, must not be breastfeeding, and must agree to use effective birth control during the study and for 6 months after.
Men with partners who can have children must take steps to prevent pregnancy during the study and for 6 months after, using effective birth control methods.
The patient must not be taking any other experimental drugs.
The patient must be 18 years or older.
The patient must have confirmed metastatic pancreatic cancer, not previously treated with systemic drugs for recurrence or metastasis, and be eligible for a specific first-line treatment.
The patient must have at least one measurable tumor, preferably checked by a CT scan or MRI.
The patient must have certain lab test results within specified limits, including:
- Bone marrow function: enough white blood cells, hemoglobin, and platelets.
- Liver function: specific enzyme levels and bilirubin within limits.
- Kidney function: creatinine levels within limits or a certain clearance rate.
The patient must have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must have completed certain treatments or procedures with specific time intervals before starting the study drug, such as:
- Focal radiation therapy at least 7 days before.
- Surgery with general anesthesia at least 7 days before.
- Surgery with local anesthesia at least 3 days before.
The patient may have had certain chemotherapy treatments as part of previous therapy if they were completed at least 6 months before joining the study.

Who Cannot Join the Study?

Patients with certain types of cancer that do not respond to treatment, known as refractory hematologic malignancies or solid tumors, cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Da Luz S.A.	Lisbon	Portugal
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA	Valencia	Spain
Ipouwbqn Cwijbg Dtnioguprfjlrezxo	L'hospitalet De Llobregat	Spain
Uemaeowzkl Ou Aldqtkh	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	06.07.2020
France	Not recruiting	06.07.2020
Portugal	Not recruiting	06.07.2020
Spain	Not recruiting	06.07.2020

Trial locations

Investigated drugs:

9-ING-41 is a medication being studied for its potential to treat patients with certain types of cancer. It works by inhibiting an enzyme called Glycogen Synthase Kinase-3 Beta (GSK-3β), which may help to stop the growth of cancer cells. This medication is being tested both on its own and in combination with chemotherapy to see if it can improve survival rates in patients with difficult-to-treat blood cancers or solid tumors.

Refractory Hematologic Malignancies – These are blood cancers that do not respond to standard treatments. They can include various types of leukemia, lymphoma, and myeloma. The disease progresses as cancer cells continue to grow and multiply despite treatment efforts. This can lead to symptoms such as fatigue, fever, and increased risk of infections. Over time, the disease may cause significant disruption to normal blood cell production. Patients often require ongoing monitoring and supportive care.

Solid Tumors – These are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, such as the lungs, breast, or colon. The progression of solid tumors involves the growth and spread of cancerous cells to surrounding tissues and potentially to other parts of the body. Symptoms depend on the tumor’s location and size, potentially causing pain, swelling, or organ dysfunction. As the tumor grows, it may interfere with normal bodily functions and require medical intervention.

Trial ID:

2024-518409-16-00

Protocol code:

1801

NCT ID:

NCT03678883

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of Elraglusib Alone or with Chemotherapy for Patients with Refractory Blood Cancers or Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?