A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening to disease progression or discontinuation from the study (up to 15 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how capivasertib affects the processing of midazolam in patients with ER-positive breast cancer. Capivasertib aims to stop cancer cell growth by interfering with specific proteins. Midazolam helps measure this effect. Capivasertib is a potent drug showing promise in various breast cancer trials.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening to disease progression or discontinuation from the study (up to 15 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening to disease progression or discontinuation from the study (up to 15 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to disease progression or discontinuation from the study (up to 15 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Midazolam AUCinf

Midazolam Cmax

Secondary study objectives

Capivasertib AUCτ

Capivasertib CL/F

Capivasertib Cmax

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Midazolam + Capivasertib)Experimental Treatment2 Interventions

Midazolam will be administered on Cycle 1 Day 1 and Cycle 1 Day 8. Capivasertib will be administrated from Cycle 1 Day 2 as an intermittent schedule (4 days on/3 days off) until discontinuation. On Cycle 1 Day 12, Midazolam will be administrated with Capivasertib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capivasertib

2021

Completed Phase 1

~130

Midazolam

2018

Completed Phase 4

~1910