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NMS-03305293 + Temozolomide for Glioblastoma

Phase 1 & 2

Recruiting

Research Sponsored by Nerviano Medical Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 2: Patients at first relapse after initial standard therapy including temozolomide with specific requirements post-surgery

Phase 1: Histologically confirmed diagnosis of an intracranial diffuse glioma (i.e. diffuse astrocytoma, oligodendroglioma or glioblastoma)

Must not have

Standard radiotherapy within three months prior to progression, specific prior radiotherapy conditions

Specific cardiac conditions, gastrointestinal diseases, recent cardiovascular events, prior invasive malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of treatment initiation until the date of death from any cause, assessed up to 9 and 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat adults with gliomas, with the goal of finding a safe and effective treatment.

Who is the study for?

Adults with a specific brain tumor called IDH wild type glioblastoma at first relapse can join this trial. They must have confirmed diagnosis, possibly after surgery, and meet certain lab value criteria. Participants need to be able to swallow capsules, use effective contraception or practice abstinence, and commit to the study schedule.

What is being tested?

The trial is testing the safety and effectiveness of combining NMS-03305293 with Temozolomide (TMZ) in treating recurrent glioblastoma. It's an open-label study where all participants receive the same treatment without a comparison group.

What are the potential side effects?

While not explicitly listed here, side effects may include those commonly associated with chemotherapy such as nausea, fatigue, hair loss (alopecia), blood disorders, and increased risk of infection due to lowered immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am experiencing my first relapse after initial treatment that included temozolomide.

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I have been diagnosed with a type of brain tumor known as diffuse glioma.

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My diagnosis is Glioblastoma, IDH-wildtype, according to WHO 2021.

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My cancer has returned after initial treatment with temozolomide, and I received no more than 12 cycles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had standard radiotherapy within the last 3 months before my condition worsened.

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I have no heart, stomach diseases, recent heart events, or other cancers.

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I have not had major surgery in the last 4 weeks.

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I have been treated with PCV, carmustine implants, bevacizumab, or PARP inhibitors.

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I am not currently on any other cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of treatment initiation until the date of death from any cause, assessed up to 9 and 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of treatment initiation until the date of death from any cause, assessed up to 9 and 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of treatment initiation until the date of death from any cause, assessed up to 9 and 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 2: Objective Response Rate

Secondary study objectives

Accumulation ratio (Rac) of NMS-03305293 and possible identified metabolites (if appropriate) after multiple doses of drug.

Apparent volume of distribution (Vd/F) of NMS-03305293 and possible identified metabolites (if appropriate) after multiple doses of drug

Area under the concentration-time curve up to the last detectable plasma concentration (AUClast) of NMS-03305293 and possible identified metabolites (if appropriate) after single and repeated dose of drug.

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NMS-03305293 +TMZExperimental Treatment2 Interventions

Phase 1 Dose Escalation: All patients will receive NMS-03305293 and temozolomide (TMZ) administered orally (NMS-03305293 once or twice daily on days 1-7 or 28 consecutive days from Day 1 to Day 28; TMZ once daily on days 1-5;) in repeated 4-week cycles aimed at defining the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Doses (RP2Ds) of NMS-03305293 in combination with TMZ. Each cycle is 28 days. Phase 2: Once the RP2D is defined, the patients will receive TMZ daily on days 1-5 in combination with NMS-03305293 at the RP2D on days 1-7 or on days 1-28 every 28 days. Backfill cohorts: additional patients may be treated with TMZ daily on days 1-5 and NMS-03305293 at different dose levels/schedules that have been previously assessed and determined to be safe, in order to properly characterize the exposure relationship over a range of doses/schedules. The backfill cohorts may run in parallel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

0 / 9Eligibility criteria met