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MDM2/MDMX Inhibitor

ALRN-6924 + Paclitaxel for Advanced Cancers

Phase 1

Waitlist Available

Led By Ecaterina E Dumbrava

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

No major surgery within 1 month of treatment and fully recovered

Estrogen receptor (ER) positive (> 1%), human epidermal growth factor 2 (HER2) negative, WT TP53 metastatic or inoperable locally advanced or locally recurrent breast cancer regardless of progesterone receptor (PR) status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of ALRN-6924 when given with paclitaxel to treat patients with solid tumors.

Who is the study for?

This trial is for adults with advanced or inoperable solid tumors, including a specific type of breast cancer (ER positive, HER2 negative) with WT TP53. Participants must not have had another cancer within the last 2 years and should have no major health issues that could affect study participation. They need to use effective contraception and cannot be pregnant or nursing.Check my eligibility

What is being tested?

The trial is testing the combination of ALRN-6924, an experimental drug, with paclitaxel, a chemotherapy medication. It aims to find the safest dose and observe how well this combo works against metastatic or unresectable solid tumors by stopping their growth or spread.See study design

What are the potential side effects?

Possible side effects include reactions related to chemotherapy such as fatigue, hair loss, nausea, neuropathy (nerve pain), and increased risk of infection. ALRN-6924 may also cause additional side effects which will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had major surgery in the last month and have fully recovered.

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My breast cancer is ER positive, HER2 negative, and cannot be removed by surgery.

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My cancer is confirmed by lab tests, has spread, and cannot be surgically removed.

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I haven't had any other cancer in the last 2 years.

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I am fully active or can carry out light work.

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My cancer is advanced or has spread, with specific genetic changes.

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My organs are functioning well.

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I am 18 years old or older.

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My TP53 gene does not have mutations, confirmed by a specific test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Maximum tolerated dose (MTD) of combination of ALRN-6924 and paclitaxel, defined as the isotonic estimate of the toxicity rate closest to 0.30

Secondary outcome measures

Clinical benefit rate

Duration of response (DoR)

Objective response rate (ORR) defined as the proportion of patients with complete response (CR) or partial response (PR), as determined by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)

+2 more

Other outcome measures

Cell proliferation and apoptosis assays

Cell-free deoxyribonucleic acid (DNA)

Gene expression profiling

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (paclitaxel, ALRN-6924)Experimental Treatment2 Interventions

Patients receive paclitaxel IV over 1 hour and MDM2/MDMX inhibitor ALRN-6924 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,118 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,746 Total Patients Enrolled

148 Trials studying Breast Cancer

63,286 Patients Enrolled for Breast Cancer

Ecaterina E DumbravaPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

What is the upper limit of individuals participating in this research trial?

"Yes, the facts posted on clinicaltrials.gov show that this medical trial is currently recruiting patients. It was initially launched on January 24th 2019 and has been edited recently in August 2022. For this study, 45 people need to be enrolled at a single site."

Answered by AI

Have any other experiments been conducted using MDM2/MDMX Inhibitor ALRN-6924?

"At the moment, 832 medical trials for MDM2/MDMX Inhibitor ALRN-6924 are being conducted worldwide. Of those active studies, 227 have entered Phase 3 and are predominantly based in Adelaide, South Australia with 45683 other sites involved."

Answered by AI

Has ALRN-6924, which inhibits MDM2/MDMX, been approved by the Food and Drug Administration?

"Since this is a Phase 1 trial, which implies that there is limited data regarding safety and efficacy, our team at Power rated MDM2/MDMX Inhibitor ALRN-6924 as a score of 1 on the scale."

Answered by AI

What indications is ALRN-6924 typically prescribed for?

"MDM2/MDMX Inhibitor ALRN-6924 is effective against neoplasm metastasis, kaposi sarcoma, and advance directives."

Answered by AI

Are there openings available to enrollees for this experimental trial?

"According to clinicaltrials.gov, the research project is currently enlisting participants; first posted on January 24th 2019 and most recently modified August 24th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ALRN-6924 and Paclitaxel in Treating Patients With Advanced, Metastatic, or Unresectable Solid Tumors

2019. "ALRN-6924 and Paclitaxel in Treating Patients With Advanced, Metastatic, or Unresectable Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03725436.

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