Study of NMS-03305293 and Temozolomide for Adults with Recurrent Glioblastoma

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What is this study about?

This clinical trial is focused on studying a type of brain cancer called recurrent glioblastoma. The study is testing a new treatment that combines two medications: NMS-03305293 and temozolomide. The purpose of the study is to find the best dose of NMS-03305293 when used with temozolomide and to see how effective this combination is in treating glioblastoma that has come back after initial treatment.

Participants in the study will take the medications in the form of hard capsules, which are swallowed. The study will be conducted in two phases. In the first phase, researchers will determine the safest and most effective dose of NMS-03305293 when combined with temozolomide. In the second phase, the study will evaluate how well this combination works in shrinking the tumor or stopping its growth in patients with a specific type of glioblastoma known as IDH wild type.

Throughout the study, participants will have regular check-ups, including MRI scans, to monitor the tumor’s response to the treatment. The study will also assess the overall safety of the medication combination by tracking any side effects experienced by participants. The trial aims to provide valuable information on the potential benefits of combining NMS-03305293 with temozolomide for treating recurrent glioblastoma.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria, including a confirmed diagnosis of recurrent glioblastoma and the ability to swallow capsules intact.

Participants must agree to use effective contraception or abstinence during the study and for a specified period after discontinuation of treatment.

2 initial assessment

An initial assessment is conducted, including a brain MRI scan to confirm measurable disease and to ensure no symptomatic and acute intratumoral hemorrhage is present.

Baseline laboratory tests are performed to ensure all acute toxic effects from prior treatments are resolved to acceptable levels.

3 treatment phase i

The first phase of treatment involves determining the maximum tolerated dose of the experimental drug NMS-03305293 in combination with temozolomide.

Participants receive temozolomide in the form of hard capsules, with dosages of 5 mg, 20 mg, or 140 mg, taken orally as prescribed by the study protocol.

4 treatment phase ii

In the second phase, the focus is on assessing the antitumor efficacy of the combination treatment in patients with specific genetic characteristics of glioblastoma.

The treatment continues with the same medications, and the response to treatment is monitored through regular assessments.

5 monitoring and follow-up

Throughout the study, participants undergo regular monitoring, including brain MRI scans and laboratory tests, to assess the safety and effectiveness of the treatment.

The study aims to evaluate the overall safety profile, including any adverse events and their relationship to the study treatment.

6 completion

Upon completion of the study, participants may undergo a final assessment to evaluate the long-term effects of the treatment.

The study is estimated to conclude by December 15, 2025.

Who Can Join the Study?

Patients must have a confirmed diagnosis of a type of brain tumor called diffuse glioma. This includes types like diffuse astrocytoma, oligodendroglioma, or glioblastoma.
Patients must be at their first relapse, meaning the tumor has returned after initial treatment.
Patients must be able to swallow capsules whole, without chewing or crushing them.
Patients must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
Patients must have a life expectancy of at least 3 months.
Patients must be able to undergo brain scans called MRI with a special dye called gadolinium.
Patients must not have any new or worsening bleeding inside the tumor, as shown on an MRI scan.
Patients must have enough tissue available for specific tests related to the tumor.
Patients must be 18 years or older.
Patients must have a certain level of physical ability, measured by a scale called ECOG performance status, which should be 2 or less. This means they can do most daily activities but may need some help.
Patients must have signed a consent form agreeing to participate in the study.
Patients must have recovered from any side effects of previous cancer treatments to a certain level, except for hair loss.
Patients must have certain baseline laboratory test results that meet the study’s requirements.
Patients must use highly effective birth control methods or practice true abstinence during the study and for a specified time after stopping the study treatment. This is important because the study drug might affect the effectiveness of hormonal birth control.
Patients on steroids must have a stable or decreasing dose for 7 days before the baseline MRI scan.
For patients who have had surgery for tumor recurrence, the surgery must have been completed at least 2 weeks before joining the study, and their condition should not have worsened since the surgery.

Who Cannot Join the Study?

Patients who have not experienced a return of their brain tumor, known as recurrent glioblastoma, cannot participate.
Patients who have not had their brain tumor come back for the first time, referred to as first relapse, are excluded.
Patients who do not have a specific type of brain tumor called isocitrate dehydrogenase (IDH) wild type glioblastoma are not eligible.
Patients who are not within the specified age range for the study cannot join.
Patients who are not able to safely tolerate the study medication, known as Maximum Tolerated Dose (MTD), are excluded.
Patients who are not suitable for the recommended dose for the next phase of the study, called Recommended Phase 2 Dose (RP2D), cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Ephsskp Umlmlptsodda Mvjzizf Cgoseku Rfncshylr (ltqkpoo Mql	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	29.10.2021
The Netherlands	Not recruiting	29.10.2021

Trial locations

Investigated drugs:

NMS-03305293 is an investigational medication being studied for its potential to treat recurrent glioblastoma, a type of brain cancer. In this clinical trial, researchers are trying to find the best dose of this medication when used in combination with another drug. They are also looking at how well it works in treating the cancer.

Temozolomide is a chemotherapy drug that is commonly used to treat certain types of brain tumors, including glioblastoma. In this study, it is being combined with NMS-03305293 to see if the combination is more effective in treating recurrent glioblastoma than using temozolomide alone.

Investigated diseases:

Glioblastoma

Recurrent Glioblastoma – Recurrent glioblastoma is a type of brain tumor that originates from the supportive tissue of the brain. It is characterized by its aggressive nature and tendency to grow rapidly. This tumor often returns after initial treatment, which is why it is termed “recurrent.” As it progresses, it can cause symptoms such as headaches, seizures, and neurological deficits depending on its location in the brain. The tumor’s growth can lead to increased pressure within the skull, affecting brain function. Recurrent glioblastoma is known for its ability to infiltrate surrounding brain tissue, making it challenging to manage.

Trial ID:

2023-508318-41-00

Protocol code:

PARPA-293-002

NCT ID:

NCT04910022

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of NMS-03305293 and Temozolomide for Adults with Recurrent Glioblastoma

What is this study about?

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Who Cannot Join the Study?