MedTrace Logo

Open Label Phase 1 Study in Japan for Patient With Advanced Solid Malignancies

NCT01353781 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-04-26

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing schedules in Japanese patients with advanced solid malignancies.

Conditions

  • Advanced Solid Malignancy
  • Advanced Solid Tumor

Interventions

DRUG

AZD5363

Patients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout.

Sponsors & Collaborators

Principal Investigators

  • Paul Stockman, MD · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT01353781 on ClinicalTrials.gov