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GSK-3β inhibitor

9-ING-41 for Advanced Cancers

Phase 2
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
Has pathologically confirmed advanced or metastatic malignancy characterized by specific criteria such as intolerance of existing therapy, refractory to existing therapy, relapse after standard therapy, or no standard therapy that improves survival by at least 3 months
Male patients with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 90 days after discontinuation of study treatment and use appropriate barrier contraception or true abstinence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months to 3 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating cancer. The drug is designed to target a protein called GSK-3β, which is found in many different types of cancer cells.

Who is the study for?
Adults with advanced or metastatic cancer, who have not responded to standard treatments or for whom no treatment improving survival by at least 3 months is available. Participants must be able to consent and follow study procedures, use effective contraception if of childbearing potential, and have adequate organ function.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of a new drug called 9-ING-41 alone or combined with other chemotherapy drugs (like Gemcitabine) in patients whose cancers haven't improved after standard treatment. It's a Phase 1/2 study targeting GSK-3β, an enzyme involved in cancer cell growth.See study design
What are the potential side effects?
Potential side effects include those commonly associated with chemotherapy such as fatigue, nausea, hair loss (except alopecia), increased risk of infection due to low blood counts, possible allergic reactions to the drug components, and other organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, and current treatments aren’t working or suitable for me.
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I am a man and will use birth control or abstain from sex to prevent pregnancy during and 90 days after the study.
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I have completed my last dose of certain treatments as required before starting the study drug.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 3 Arm B
Parts 1/2: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Group I: 9-ING-41 plus nab paclitaxel GemcitabineExperimental Treatment3 Interventions
Drugs: Nab-paclitaxel. Gemcitabine - 28 day cycle. 9-ING-41.
Group II: 9-ING-41 plus Paclitaxel/CarboplatinExperimental Treatment3 Interventions
Drugs: Paclitaxel. Carboplatin. 9-ING-41.
Group III: 9-ING-41 plus LomustineExperimental Treatment2 Interventions
Drugs: Lomustine. 9-ING-41.
Group IV: 9-ING-41 plus IrinotecanExperimental Treatment2 Interventions
Drugs: Irinotecan. 9-ING-41.
Group V: 9-ING-41 plus GemcitabineExperimental Treatment2 Interventions
Drugs: Gemcitabine - 21 day cycle. 9-ING-41
Group VI: 9-ING-41 plus DoxorubicinExperimental Treatment2 Interventions
Drugs: Doxorubicin. 9-ING-41
Group VII: 9-ING-41 plus CarboplatinExperimental Treatment2 Interventions
Drugs: Carboplatin. 9-ING-41.
Group VIII: 9-ING-41Experimental Treatment1 Intervention
Drug: 9-ING-41
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
9-ING-41
2020
Completed Phase 2
~20
Lomustine
2008
Completed Phase 3
~1540
Irinotecan
2017
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

Actuate Therapeutics Inc.Lead Sponsor
8 Previous Clinical Trials
222 Total Patients Enrolled
Francis Giles, MDStudy ChairATI
2 Previous Clinical Trials
279 Total Patients Enrolled
Steven D Reich, MDStudy ChairActuate Therapeutics Inc.
7 Previous Clinical Trials
297 Total Patients Enrolled

Media Library

9-ING-41 (GSK-3β inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03678883 — Phase 2
Bone Cancer Research Study Groups: 9-ING-41 plus Gemcitabine, 9-ING-41 plus Doxorubicin, 9-ING-41, 9-ING-41 plus Lomustine, 9-ING-41 plus Carboplatin, 9-ING-41 plus nab paclitaxel Gemcitabine, 9-ING-41 plus Paclitaxel/Carboplatin, 9-ING-41 plus Irinotecan
Bone Cancer Clinical Trial 2023: 9-ING-41 Highlights & Side Effects. Trial Name: NCT03678883 — Phase 2
9-ING-41 (GSK-3β inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03678883 — Phase 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 cap for enrolment in this clinical examination?

"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial, which launched on April 1st 2019, is currently enlisting participants. The study requires 350 people to be recruited from 9 distinct medical centres."

Answered by AI

Is this a pioneering research endeavor?

"Presently, 1953 active trials of 9-ING-41 are being conducted throughout the globe in 4027 towns and 88 countries. Alfacell initially initiated a trial for this drug back in 1997 with 300 participants which ultimately reached Phase 3 approval. Since that time, 3414 studies have been finished."

Answered by AI

Could you provide a breakdown of the various locations where this trial is being conducted?

"Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago, Illinois, Fred Hutchinson Cancer Research Center in Phoenix, Arizona, and Rhode island Hospital in Seattle, Washington are just some of the sites offering this trial to patients."

Answered by AI

Are there still spaces available for prospective participants in this experiment?

"Affirmative. The online listing for this clinical trial on clinicaltrials.gov indicates that, as of May 5th 2022, it is still actively recruiting participants across 9 different sites in need of 350 patients total. This experiment was first posted to the website on April 1st 2019."

Answered by AI

In what ways is 9-ING-41 typically employed?

"9-ING-41 is primarily used to treat joint conditions, but it has also proven effective in alleviating the symptoms of various other afflictions such as Kaposi's sarcoma AIDS related, initial treatment and metastatic bladder cancer."

Answered by AI

What prior experiments have utilized 9-ING-41 as a research sample?

"In 1997, Spectrum Health Hospital - Butterworth Campus initially researched 9-ING-41. Since then, 3414 trials have been satisfactorily concluded and 1953 are currently ongoing; many of these studies take place in the city of Chicago, Illinois."

Answered by AI

Who else is applying?

What site did they apply to?
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
McGill University Health Centre
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~41 spots leftby Nov 2024