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9-ING-41 for Myelofibrosis

Q: What are the primary benefits of 9-ING-41?

<p>9-ING-41 is not only useful in treating <a href="https://www.withpower.com/clinical-trials/polycythemia-vera">polycythemia vera</a>, but also other blood disorders such as hydroxyurea resistance and primary <a href="https://www.withpower.com/clinical-trials/myelofibrosis">myelofibrosis</a>.</p>

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

Patient has documented diagnosis of symptomatic primary MF, PPV-MF or PET-MF as defined by the World Health Organization classification

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-24 months

Awards & highlights

Study Summary

This trial will study if 9-ING-41 is an effective treatment for advanced myelofibrosis, a type of cancer that affects the bone marrow.

Who is the study for?

Adults with advanced myelofibrosis who've tried Ruxolitinib for at least 12 weeks without success can join this trial. They must have proper organ function, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with recent heart attacks, hypersensitivity to the drug's components, vulnerable populations like prisoners, or using certain herbal medications.Check my eligibility

What is being tested?

The study is testing the effectiveness of a new treatment called 9-ING-41 in patients with advanced myelofibrosis. It's being given alongside Ruxolitinib—a previously attempted therapy—to see if it improves patient outcomes without causing additional bone marrow suppression.See study design

What are the potential side effects?

While specific side effects of 9-ING-41 aren't listed here, common concerns may include reactions at the infusion site, potential liver enzyme elevations (as monitored by lab tests), and general risks associated with cancer treatments such as fatigue and digestive issues.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-24 months

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

Response rate

Trial Design

2Treatment groups

Experimental Treatment

Group I: 9-ING-41 plus RuxolitinibExperimental Treatment2 Interventions

9-ING-41 9.3 mg/kg will be administered by intravenous infusion twice weekly for cycle durations of 28 days with Ruxolitinib at doses specified in the protocol as appropriate for patient's platelet count.

Group II: 9-ING-41Experimental Treatment1 Intervention

9-ING-41 is administered by intravenous infusion twice weekly at a dose of 9.3 mg/kg. Cycle duration is 28 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1140

9-ING-41

2020

Completed Phase 2

~20

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Actuate Therapeutics Inc.Lead Sponsor

8 Previous Clinical Trials

555 Total Patients Enrolled

Ludimila Cavalcante, MDStudy DirectorActuate Therapeutics

Steven D Reich, MDStudy DirectorActuate Therapeutics Inc.

7 Previous Clinical Trials

630 Total Patients Enrolled

Media Library

9-ING-41 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04218071 — Phase 2

Myelofibrosis Research Study Groups: 9-ING-41, 9-ING-41 plus Ruxolitinib

Myelofibrosis Clinical Trial 2023: 9-ING-41 Highlights & Side Effects. Trial Name: NCT04218071 — Phase 2

9-ING-41 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04218071 — Phase 2

Frequently Asked Questions

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

Is this study popular in Canadian hospitals?

"So far, 11 hospitals have signed up to participate in this study. Some notable locations include the Cleveland Clinic in Ohio, Winship Cancer Institute in Georgia, and Brown University's hospital in Rhode island."

Answered by AI

What are the dangers of 9-ING-41 for test subjects?

"9-ING-41 has undergone some safety testing and received a score of 2."

Answered by AI

Are we still looking for participants for this research?

"The trial is still recruiting patients, according to the clinicaltrials.gov website. This research was originally posted on August 20th 2020 and was updated as recently as April 26th, 2022."

Answered by AI

What other medical research has been conducted using 9-ING-41?

"9-ING-41 was first studied in 2002 at the National Institutes of Health Clinical Center. To date, there are 92 completed trials and 103 live clinical trials taking place around the world; many of these active studies are based in Cleveland, Ohio."

Answered by AI

What are the primary benefits of 9-ING-41?

"9-ING-41 is not only useful in treating polycythemia vera, but also other blood disorders such as hydroxyurea resistance and primary myelofibrosis."

Answered by AI

How many trial participants are currently enrolled?

"The researchers conducting this trial need 58 patients that fall under the pre-determined inclusion criteria. These participants can be recruited from multiple medical facilities, such as Cleveland Clinic in Cleveland, Ohio and Winship Cancer Institute, Emory University in Atlanta, Georgia."

Answered by AI

Recent research and studies

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Ding, Li, Vijay S. Madamsetty, Spencer Kiers, Olga Alekhina, Andrey Ugolkov, John Dube, Yu Zhang, et al.. 2019. “Glycogen Synthase Kinase-3 Inhibition Sensitizes Pancreatic Cancer Cells to Chemotherapy by Abrogating the Topbp1/atr-mediated DNA Damage Response”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-19-0799.

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Inhibition of Glycogen Synthase Kinase 3β Blocks Mesomesenchymal Transition and Attenuates Streptococcus Pneumonia–mediated Pleural Injury in Mice

Boren, Jake, Grant Shryock, Alexis Fergis, Ann Jeffers, Shuzi Owens, Wenyi Qin, Kathleen B. Koenig, et al.. 2017. “Inhibition of Glycogen Synthase Kinase 3β Blocks Mesomesenchymal Transition and Attenuates Streptococcus Pneumonia–mediated Pleural Injury in Mice”. The American Journal of Pathology. Elsevier BV. doi:10.1016/j.ajpath.2017.07.007.

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Glycogen Synthase Kinase-3β Inhibition with 9-ING-41 Attenuates the Progression of Pulmonary Fibrosis

Jeffers, Ann, Wenyi Qin, Shuzi Owens, Kathleen B. Koenig, Satoshi Komatsu, Francis J. Giles, Daniel M. Schmitt, Steven Idell, and Torry A. Tucker. 2019. “Glycogen Synthase Kinase-3β Inhibition with 9-ING-41 Attenuates the Progression of Pulmonary Fibrosis”. Scientific Reports. Springer Science and Business Media LLC. doi:10.1038/s41598-019-55176-w.

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