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AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology Studies

NCT03313557 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-06-24

No results posted yet for this study

Summary

Open-label, non-randomised study to provide continued access to AZD1775 for patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of AZD1775.

Conditions

Interventions

DRUG

Wee-1 kinase inhibitor AZD1775

Patients will receive AZD1775 300 mg orally once daily. Days 1 to 5 and 8 to 12 of a 21 day cycle (ie, 5 days on and 2 days off for Weeks 1 and 2 of a 21-day cycle). All patients must receive a serotonin receptor 3 (5-HT3) antagonist, ondansetron (Zofran) 8 mg orally/IV or granisetron (Kytril) 1 mg orally/IV prior to each dose of AZD1775. Dexamethasone 4 mg orally/IV will be given with each AZD1775 dose at a minimum on the first day of dosing of AZD1775 of every 5 day dosing period, unless contraindicated or not well-tolerated.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Lone Ottesen, MD · AstraZeneca

  • Henk Verheul, MD · Amsterdam UMC, location VUmc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-27
Primary Completion
2019-05-17
Completion
2019-05-17
FDA Drug
Yes

Countries

  • United States
  • France
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03313557 on ClinicalTrials.gov