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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)

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Number of Participants with first-cycle dose limiting toxicity

Phase 2: Objective Response Rate

Secondary outcome measures

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

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

~1930

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nerviano Medical SciencesLead Sponsor

12 Previous Clinical Trials

790 Total Patients Enrolled

Media Library

Lomustine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04910022 — Phase 1 & 2

Glioblastoma Research Study Groups: NMS-03305293 +TMZ

Glioblastoma Clinical Trial 2023: Lomustine Highlights & Side Effects. Trial Name: NCT04910022 — Phase 1 & 2

Lomustine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04910022 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this research attempting to achieve?

"In accordance with the research sponsor, Nerviano Medical Sciences, primary results which will be observed over a period of 6 months from randomization include assessment of first-cycle dose limiting toxicity. Additionally, secondary outcomes to measure include Evaluation of Area under the concentration-time curve up to the last detectable plasma concentration (AUClast) for NMS-03305293 after single and repeated doses; Objective Tumor Response according to RANO criteria; as well as Accumulation ratio (Rac) for NMS-03305293 after multiple drug administrations - all assessed using collected Plasma samples in order to gauge pharmacokinetic characteristics"

Answered by AI

What is the aggregate figure of individuals participating in this medical experiment?

"Affirmative. Clinicaltrials.gov records show that this investigation, which was originally published on December 1st 2021, is actively sourcing for participants. A total of 125 individuals will be recruited from 2 distinct medical centres."

Answered by AI

What results have been observed from previous experiments with the combination of NMS-03305293 + TMZ?

"The NMS-03305293 + TMZ combination was first trialled in 2003 at the M. D. Anderson Cancer Center of University of Texas. There have been 28 studies since its inception, with 21 ongoing trials presently conducted primarily out of Rochester, Minnesota."

Answered by AI

Are there still opportunities to join this research initiative?

"Data posted to clinicaltrials.gov reveals that this trial is actively seeking enrollees, with the initial posting dating back to December 1st 2021 and a most recent update from November 7th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ph I/II Study of NMS-03305293+TMZ in Adult Patients With Recurrent Glioblastoma

2021. "Ph I/II Study of NMS-03305293+TMZ in Adult Patients With Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04910022.