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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

Patient is aged ≥ 18 years

Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG) PS 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months to 3 years

Awards & highlights

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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I am 18 years old or older.

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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months to 3 years

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

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

0 / 2Eligibility criteria met

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

Lung Cancer Research Study Groups: 9-ING-41 plus Paclitaxel/Carboplatin, 9-ING-41 plus Gemcitabine, 9-ING-41 plus Doxorubicin, 9-ING-41 plus Carboplatin, 9-ING-41 plus nab paclitaxel Gemcitabine, 9-ING-41 plus Irinotecan, 9-ING-41, 9-ING-41 plus Lomustine

Lung 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