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Protein Kinase Inhibitor

Omeprazole for Solid Tumors

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 arm a: days 1-4 and 9-12; arm b: days 1-4 and 14-17; arm c: days 1-4 and 9-12
Awards & highlights

Study Summary

This study is evaluating whether a drug called lorlatinib can be safely combined with another drug called trametinib.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~arm a: days 1-4 and 9-12; arm b: days 1-4 and 14-17; arm c: days 1-4 and 9-12
This trial's timeline: 3 weeks for screening, Varies for treatment, and arm a: days 1-4 and 9-12; arm b: days 1-4 and 14-17; arm c: days 1-4 and 9-12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ratios of geometric means of AUCinf (Area under plasma concentration-time curve from time zero to infinity) when administered in combination with itraconazole/rifampicin/omeprazole relative to adavosertib alone
Ratios of geometric means of AUClast (Area under the plasma concentration-time curve from zero to time of last quantifiable concentration) when administered in combination with itraconazole/rifampicin/omeprazole relative to adavosertib alone
Ratios of geometric means of Cmax (maximum observed plasma concentration) when administered in combination with itraconazole/rifampicin/omeprazole relative to adavosertib alone
Secondary outcome measures
Descriptive statistics of AUCinf
Descriptive statistics of AUClast
Descriptive statistics of CL/F (Apparent total body clearance of drug from plasma after extravascular administration)
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment2 Interventions
Patients will receive a single oral dose of adavosertib alone, and a single oral dose of adavosertib concomitantly with omeprazole.
Group II: Arm BExperimental Treatment2 Interventions
Patients will receive a single oral dose of adavosertib alone, and a single oral dose of adavosertib concomitantly with rifampicin.
Group III: Arm AExperimental Treatment2 Interventions
Patients will receive a single oral dose of adavosertib alone, and a single oral dose of adavosertib concomitantly with itraconazole.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adavosertib
2015
Completed Phase 2
~570
Itraconazole
2017
Completed Phase 2
~780
Rifampicin
2013
Completed Phase 4
~790
Omeprazole
2006
Completed Phase 4
~940

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,698 Total Patients Enrolled
ParexelIndustry Sponsor
304 Previous Clinical Trials
101,147 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib
2021. "A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04959266.
~1 spots leftby Apr 2025
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