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NG101m Adjuvant Therapy for Glioblastoma

Phase 1 & 2

Waitlist Available

Research Sponsored by NeuGATE Theranostics

Eligibility Criteria Checklist

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

Must have

Primary treatment must consist of a chemoradiation therapy (CRT) regimen

Must not be on any other alternative therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new drug to see if it helps people with glioblastoma multiforme, a type of brain cancer.

Who is the study for?

This trial is for adults over 18 with newly diagnosed glioblastoma who are set to start chemoradiation therapy. They must have certain blood and organ function levels, not be pregnant or breastfeeding, and can't be on other therapies or have specific allergies or diseases like immunodeficiency or autoimmune disorders.Check my eligibility

What is being tested?

The trial tests NG101m capsules as an add-on to the standard glioblastoma treatment, which includes temozolomide chemotherapy and intensity-modulated radiation therapy. The goal is to see if adding NG101m improves outcomes.See study design

What are the potential side effects?

Potential side effects of NG101m aren't specified here but may include reactions related to vitamin A, D3, L-citrulline (its components), plus common cancer treatment side effects from chemo and radiation such as fatigue, nausea, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My main treatment is a combination of chemotherapy and radiation.

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I am not using any alternative therapies.

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I am able to care for myself but may not be able to do active work.

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I have been recently diagnosed with glioblastoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate.

Number of participants with treatment-emergent adverse events and serious adverse events

Secondary outcome measures

Progression-free survival (PFS)

Quality of Life (QoL)

Response assessment in neuro-oncology (RANO) criteria

Other outcome measures

Identify and quantify immune/effector cells

Trial Design

1Treatment groups

Experimental Treatment

Group I: NG101m and standard treatmentExperimental Treatment3 Interventions

Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity-modulated radiation therapy

2006

Completed Phase 3

~1240

Temozolomide

2010

Completed Phase 3

~1930

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

NeuGATE TheranosticsLead Sponsor

Yvonne Kew, MD, PhDStudy DirectorNeuGATE Theranostics

Media Library

Intensity-modulated radiation therapy Clinical Trial Eligibility Overview. Trial Name: NCT04373785 — Phase 1 & 2

Glioblastoma Research Study Groups: NG101m and standard treatment

Glioblastoma Clinical Trial 2023: Intensity-modulated radiation therapy Highlights & Side Effects. Trial Name: NCT04373785 — Phase 1 & 2

Intensity-modulated radiation therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04373785 — 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 is the uppermost limit of participants in this clinical experiment?

"At this time, no further enrolment is possible for this medical trial. It was initially made available on the 1st of January 2023 and last updated on April 22nd 2022. Should you be interested in other research initiatives, there are currently 441 studies searching for glioblastoma patients and 207 trials actively recruiting participants for NG101m therapy."

Answered by AI

Is this experiment a pioneering effort in its field?

"There are over 900 cities and 36 nations with active clinical trials for NG101m. This substance was initially researched in 2002 by Schering-Plough, which ran a 60 participant Phase 2 drug approval study: since then, 301 investigations have been completed."

Answered by AI

Has NG101m been the subject of any other investigations?

"Currently, 207 clinical trials are being conducted with regard to NG101m. Of those studies, 24 have advanced to Phase 3 and the majority occur in Seoul Songpa. However, 4752 medical centres around the world are running research on this drug treatment."

Answered by AI

Is participation in this research endeavor still available to patients?

"Unfortunately, no additional patients are being sought for this trial at present. As of April 22nd 2022, the study has not been updated since its initial posting on January 1st 2023. On the bright side, there are a plethora of open trials recruiting participants with glioblastoma (441) and NG101m (207)."

Answered by AI

In what conditions is NG101m typically employed?

"NG101m is the typical nitrosourea treatment, however it can also be beneficial for numerous other medical cases such as refractory mycosis fungoides, advanced directives and neuroblastoma that have become resistant to conventional treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NG101m Adjuvant Therapy in Glioblastoma Patients

2024. "NG101m Adjuvant Therapy in Glioblastoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04373785.

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