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Glycogen Synthase Kinase-3 Beta Inhibitor

9-ING-41 for Pediatric Cancer

Phase 1

Waitlist Available

Research Sponsored by Actuate Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Have fully recovered from the acute clinically significant toxic effects of prior anti-cancer therapy

Have either measurable or evaluable disease. Evaluable disease is defined as an assessment of tumor that cannot be measured using a ruler or calipers, but can be used to determine disease progression or response (e.g., positive lesions on MIBG or bone scan, metastatic bone marrow disease, elevated tumor markers, or presence of a malignant pleural effusion)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-12 months

Awards & highlights

Study Summary

This trial will study whether 9-ING-41 can shrink tumors in kids with cancer without causing serious side effects.

Who is the study for?

This trial is for children and young adults under 22 with various advanced cancers, including brain tumors and neuroblastoma. Participants must have tried at least one treatment before, be in a stable condition, and have a certain level of physical ability. Pregnant individuals or those with uncontrolled illnesses, prior organ transplants, or severe reactions to the drugs being tested cannot join.Check my eligibility

What is being tested?

The study tests the drug 9-ING-41's effectiveness in pediatric patients with cancer that hasn't responded to other treatments. It will be given alongside existing chemotherapy drugs like Temozolomide and Irinotecan to see if it improves outcomes without significant toxicity.See study design

What are the potential side effects?

While not detailed here, potential side effects may include typical chemotherapy-related issues such as nausea, fatigue, hair loss (except alopecia), blood cell count changes leading to increased infection risk or bleeding problems; specific drug sensitivities could also occur.

Eligibility Criteria

Inclusion Criteria

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

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I have recovered from side effects of my previous cancer treatments.

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My cancer can be tracked by doctors, either by measuring it or through other tests.

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My cancer has come back or hasn't responded to treatment, confirmed by tests.

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My neurological condition has been stable for a week, and if I'm on steroids, the dose hasn't increased.

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I am mostly able to care for myself, regardless of my age.

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I have undergone at least one initial treatment for my cancer.

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My organs and bone marrow are functioning well.

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I am younger than 22 years old.

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My condition has no cure or treatments that would extend life with good quality.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-12 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

Number of participants with treatment-related adverse events as assessed by CTCAE v5

Trial Design

4Treatment groups

Experimental Treatment

Group I: 9-ING-41 plus Irinotecan plus TemozolomideExperimental Treatment3 Interventions

9-ING-41 will be administered by intravenous infusion twice weekly at an initial dose of 9.3 mg/kg. Irinotecan will be administered at a dose of 50 mg/m2/day over 90 minutes IV on days 1-5 every 21 days. Temozolomide will be administered at a dose of 100 mg/m2/dose by mouth on Days 1 through 5 ((cycle duration is 21 days).

Group II: 9-ING-41 plus IrinotecanExperimental Treatment2 Interventions

Group III: 9-ING-41 plus Cyclophosphamide plus TopotecanExperimental Treatment3 Interventions

Cyclophosphamide 400 mg/m2/dose administered intravenously over 30 min on Days 1 through 5. Topotecan 1.2 mg/m2/dose administered intravenously over 30 min once on Days 1 through 5. 9-ING-41 intravenous infusion twice weekly (cycle duration is 21 days).

Group IV: 9-ING-41Experimental Treatment1 Intervention

9-ING-41 will be administered by intravenous infusion twice weekly at an initial dose of 9.3 mg/kg. Cycle duration is 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topotecan

2017

Completed Phase 3

~2400

9-ING-41

2020

Completed Phase 2

~20

Temozolomide

2010

Completed Phase 3

~1930

Irinotecan

2017

Completed Phase 4

~2680

Cyclophosphamide

1995

Completed Phase 3

~3770

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Actuate Therapeutics Inc.Lead Sponsor

8 Previous Clinical Trials

504 Total Patients Enrolled

Francis Giles, MDStudy ChairATI

2 Previous Clinical Trials

561 Total Patients Enrolled

Steven D Reich, MDStudy ChairActuate Therapeutics Inc.

7 Previous Clinical Trials

579 Total Patients Enrolled

Media Library

9-ING-41 (Glycogen Synthase Kinase-3 Beta Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04239092 — Phase 1

Diffuse Intrinsic Pontine Glioma Research Study Groups: 9-ING-41 plus Cyclophosphamide plus Topotecan, 9-ING-41, 9-ING-41 plus Irinotecan, 9-ING-41 plus Irinotecan plus Temozolomide

Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: 9-ING-41 Highlights & Side Effects. Trial Name: NCT04239092 — Phase 1

9-ING-41 (Glycogen Synthase Kinase-3 Beta Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04239092 — Phase 1

Frequently Asked Questions

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

What maladies is 9-ING-41 regularly recommended to address?

"9-ING-41 is a common remedy for radiotherapy, as well as hodgkin disease, lymphocytic leukemias, and chronic granulocytic leukemia."

Answered by AI

Could you elucidate on any past experiments involving 9-ING-41?

"First examined by City of Hope Comprehensive Cancer Center in 1997, 9-ING-41 has been the subject of 1971 clinical trials. Currently, 1272 live trials are underway; many being conducted out of Charlotte, North carolina."

Answered by AI

Are investigators currently enrolling participants for this research project?

"According to clinicaltrials.gov, the trial is currently recruiting participants that meet its criteria. This research was first posted on June 5th 2020 and was last updated April 26th 2022."

Answered by AI

What is the current enrollment rate for this research endeavor?

"In order to complete the trial, 68 participants who are eligible according to the criteria must be recruited. These individuals can obtain treatment at facilities like Levine Cancer Center in Charlotte, North carolina and Duke Children's Hospital and Health Center, Duke University Medical Centre in Durham, Michigan."

Answered by AI

What potential dangers should one be aware of when using 9-ING-41?

"As this is a Phase 1 clinical trial, the safety of 9-ING-41 was tentatively rated at 1 due to limited data regarding its efficacy and security."

Answered by AI

In how many distinct locations is this trial currently being conducted?

"Presently, 9 distinct clinics are looking for trial participants. Locations range from Ann Arbor and Durham to Charlotte, in addition to 6 other clinical sites. To reduce travel-related expenses associated with the study, we recommend selecting a clinic that is close by your location."

Answered by AI

Recent research and studies

Cancer LettersJournal

GSK-3 Inhibition Overcomes Chemoresistance in Human Breast Cancer

Ugolkov, Andrey, Irina Gaisina, Jin-San Zhang, Daniel D. Billadeau, Kevin White, Alan Kozikowski, Sarika Jain, et al.. 2016. “GSK-3 Inhibition Overcomes Chemoresistance in Human Breast Cancer”. Cancer Letters. Elsevier BV. doi:10.1016/j.canlet.2016.07.006.

Scientific ReportsJournal

9-ING-41, a Small Molecule Inhibitor of Gsk-3beta, Potentiates the Effects of Anticancer Therapeutics in Bladder Cancer

Kuroki, Hiroo, Tsutomu Anraku, Akira Kazama, Vladimir Bilim, Masayuki Tasaki, Daniel Schmitt, Andrew P. Mazar, Francis J Giles, Andrey Ugolkov, and Yoshihiko Tomita. 2019. “9-ING-41, a Small Molecule Inhibitor of Gsk-3beta, Potentiates the Effects of Anticancer Therapeutics in Bladder Cancer”. Scientific Reports. Springer Science and Business Media LLC. doi:10.1038/s41598-019-56461-4.

Anti-Cancer DrugsJournal

9-ING-41, a Small-molecule Glycogen Synthase Kinase-3 Inhibitor, Is Active in Neuroblastoma

Ugolkov, Andrey V., Gennadiy I. Bondarenko, Oleksii Dubrovskyi, Ana P. Berbegall, Samuel Navarro, Rosa Noguera, Thomas V. O’Halloran, Mary J. Hendrix, Francis J. Giles, and Andrew P. Mazar. 2018. “9-ING-41, a Small-molecule Glycogen Synthase Kinase-3 Inhibitor, Is Active in Neuroblastoma”. Anti-cancer Drugs. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/cad.0000000000000652.

BloodJournal