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GSK-3β inhibitor

9-ING-41 + Carboplatin for Salivary Gland Cancer

Phase 2

Waitlist Available

Led By Glenn J Hanna, MD

Research Sponsored by Glenn J. Hanna

Eligibility Criteria Checklist

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

Must have

Organ and marrow function within specified limits

Age 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks up to 1 year

Awards & highlights

Study Summary

This trial is investigating if the addition of 9-ING-41 to carboplatin chemotherapy can improve outcomes in patients with advanced salivary gland cancers.

Who is the study for?

Adults with advanced salivary gland cancer, including adenoid cystic carcinoma, who have not responded to previous treatments or whose disease has returned. They must be in relatively good health with proper organ and bone marrow function, able to provide tissue samples, and willing to use effective contraception.Check my eligibility

What is being tested?

The trial is testing the effectiveness of a new drug called 9-ING-41 (a GSK-3β inhibitor) when given through IV alongside Carboplatin chemotherapy. The goal is to see if this combination can help treat advanced salivary gland cancers more effectively.See study design

What are the potential side effects?

Potential side effects may include reactions related to the infusion process, impact on blood cells leading to increased infection risk or bleeding problems, kidney or liver function changes, fatigue, and other common chemotherapy-related side effects.

Eligibility Criteria

Inclusion Criteria

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

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My organ and bone marrow functions are within normal ranges.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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My salivary gland cancer has returned, spread, or cannot be surgically removed.

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I am willing to provide samples from my previous cancer surgery or biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Overall response rate

Secondary outcome measures

Duration of therapeutic response

Duration of therapeutic response Cohort 1

Duration of therapeutic response Cohort 2

+4 more

Side effects data

From 2008 Phase 2 trial • 149 Patients • NCT02004093

59%

Nausea

59%

Diarrhoea

48%

Neutropenia

40%

Fatigue

32%

Vomiting

29%

Alopecia

27%

Constipation

25%

Decreased appetite

25%

Anaemia

24%

Abdominal pain

23%

Rash

21%

Headache

19%

Epistaxis

15%

Drug hypersensitivity

15%

Arthralgia

15%

Thrombocytopenia

15%

Neuropathy peripheral

13%

Dysgeusia

13%

Stomatitis

12%

Asthenia

12%

Dizziness

12%

Dyspepsia

12%

Leukopenia

11%

Dyspnoea

11%

Nail disorder

11%

Peripheral sensory neuropathy

Mucosal inflammation

Pruritus

Muscle spasms

Cystitis

Insomnia

Hemorrhoids

Back pain

Hypertension

Pain in extremity

Urinary tract infection

Cough

Musculoskeletal pain

Flushing

Myalgia

Erythema

Bone pain

Nasopharyngitis

Abdominal pain upper

Chest pain

Pyrexia

Dry skin

Lethargy

Paraesthesia

Abdominal pain lower

Vaginal discharge

Oedema peripheral

Phlebitis

Intestinal obstruction

Abdominal distension

Ascites

Gastrointestinal haemorrhage

Local swelling

Pulmonary embolism

Diaphragmatic hernia

Cardiac failure congestive

Hepatic lesion

Blood glucose increased

Lower respiratory tract infection

Pneumonia

Syncope

Ileus paralytic

Left ventricular dysfunction

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy + Pertuzumab

Chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: 9-ING-41 + carboplatinExperimental Treatment2 Interventions

Participants will be divided into 2 cohorts: Salivary Gland Cancer with adenoid cystic carcinoma (ACC) and Salivary Gland Cancer without adenoid cystic carcinoma (ACC) and receive: 9-ING-41 2x every 21 day study cycle on Day 1 and Day 4 up to 1 year with option to continue beyond if participant is showing benefit Carboplatin 1x every 21 day study cycle on Day 1 up to 1 year

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

9-ING-41

Not yet FDA approved

Carboplatin

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Glenn J. HannaLead Sponsor

3 Previous Clinical Trials

85 Total Patients Enrolled

Actuate Therapeutics Inc.Industry Sponsor

8 Previous Clinical Trials

537 Total Patients Enrolled

Glenn J Hanna, MDPrincipal InvestigatorDana-Farber Cancer Institute

4 Previous Clinical Trials

92 Total Patients Enrolled

Media Library

9-ING-41 (GSK-3β inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05010629 — Phase 2

9-ING-41 (GSK-3β inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010629 — Phase 2

Salivary Gland Cancer Research Study Groups: 9-ING-41 + carboplatin

Salivary Gland Cancer Clinical Trial 2023: 9-ING-41 Highlights & Side Effects. Trial Name: NCT05010629 — Phase 2

Frequently Asked Questions

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

How many individuals are being research subjects in this investigation?

"That is correct. The listed clinical trial on clinicaltrials.gov is recruiting patients as of right now. This particular study was first made public on September 14th, 2021 and has been updated as recently as October 17th, 2022. There are 35 total spots for participants at 2 locations."

Answered by AI

What are the most common maladies that 9-ING-41 has been shown to impact?

"9-ING-41 is a medication used to treat non-Hodgkin lymphoma. This drug can also be effective in managing advanced sarcoma, hodgkin disease, and as an initial treatment for cancer patients."

Answered by AI

Are new patients being accepted into this trial at this time?

"That is accurate. The study, which began recruiting on September 14th 2021 according to information available on clinicaltrials.gov, is still looking for participants. Up to 35 patients will be accepted at 2 different locations."

Answered by AI

What is the current status of 9-ING-41 in regards to government approval?

"9-ING-41 falls into the category of a Phase 2 trial medication, which means that while there is data attesting to its safety, there is none yet confirming its efficacy. We've given it a score of 2."

Answered by AI

Who else is applying?

What site did they apply to?

Brigham and Women's Hospital

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have a reoccurance of ACC and have been treated in MN at Masonic Cancer Center and Mayo Clinic in Rochester MN. I am looking for continual care and will need more treatment. Thankyou.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma

Glenn J. Hanna 2021. "9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05010629.

All > Adenoid Cystic Carcinoma