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PRMT5 Inhibitor

AZD3470 for Advanced Solid Cancers (PRIMROSE Trial)

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the ICF.

Participants must have received and progressed, are refractory or are intolerant to standard therapy for the specific tumour type. All participants are required to have had at least one prior line of treatment in the recurrent or metastatic setting.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first dose of azd3470 up until the date of death due to any cause (approximately 2 years).

Awards & highlights

PRIMROSE Trial Summary

This trial studies the safety & effectiveness of a drug to treat advanced or metastatic solid tumours. It will evaluate safety, tolerability, & preliminary efficacy.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors that lack MTAP, a specific gene. Participants must have tried standard treatments without success and should be in fairly good health (able to perform daily activities with ease or some limitation). They need at least one tumor that can be measured by medical scans and should expect to live at least 12 more weeks.Check my eligibility

What is being tested?

The study tests AZD3470, a new drug targeting PRMT5 enzymes in patients whose tumors don't have the MTAP gene. It's an early-phase trial assessing how safe the drug is, how well it's tolerated, its pharmacokinetics (how it moves through the body), effects on the body, and initial signs of effectiveness.See study design

What are the potential side effects?

Since this is a first-in-human study for AZD3470, detailed side effects are not yet known. However, participants may experience typical cancer treatment-related side effects such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems.

PRIMROSE Trial Eligibility Criteria

Inclusion Criteria

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

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I am at least 18 years old or the legal age of consent where the study is conducted.

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My cancer has not responded to or I cannot tolerate the standard treatment, and I have had at least one treatment for it when it came back or spread.

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My tumor lacks MTAP due to gene deletion or no MTAP protein expression.

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I am fully active or can carry out light work.

PRIMROSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose of azd3470 up until the date of death due to any cause (approximately 2 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first dose of azd3470 up until the date of death due to any cause (approximately 2 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of azd3470 up until the date of death due to any cause (approximately 2 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

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Incidence of dose-limiting toxicities (DLT)

Secondary outcome measures

Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Dextromethorphan: AUC

Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Dextromethorphan: Cmax

Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Midazolam: AUC

+12 more

PRIMROSE Trial Design

1Treatment groups

Experimental Treatment

Group I: AZD3470 MonotherapyExperimental Treatment1 Intervention

Part A dose escalation and DDI and Part B dose optimisation and expansion in varying doses of AZD3470

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,493 Total Patients Enrolled

Frequently Asked Questions

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

How many venues have been selected to administer this trial?

"At present, this trial is seeking patients from 4 distinct medical centres. These locations spread across Portland, Fairfax and Barcelona with an additional four sites. To lessen the burden of travel for those who enrol, participants should choose the site closest to them."

Answered by AI

Are there any remaining opportunities for participants in this trial?

"According to clinicaltrials.gov, the trial is no longer recruiting and has not been since its last edit on November 8th 2023. Although this study is not currently enrolling participants, 2583 other medical trials are actively searching for volunteers at present."

Answered by AI

What are the ultimate objectives of this medical experiment?

"Per AstraZeneca, the primary measure of efficacy will be dose-limiting toxicities (DLT) during a 28 day period post last AZD3470 dosage. Secondary objectives include assessing radiological response according to RECIST v1.1 standards and determining dextromethorphan's pharmacokinetics when taken with or without AZD 3470 via Cmax measures plus calculating an objective response rate for patients who experience complete or partial responses as per RECIST 1.1 criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumours

2024. "A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06130553.

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