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AZD9291 First Time In Patients Ascending Dose Study

NCT01802632 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2026-04-20

Study results available
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Summary

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

Conditions

  • Advanced Non Small Cell Lung Cancer
  • Advanced (Inoperable) Non Small Cell Lung Cancer

Interventions

DRUG

AZD9291

Starting dose 20 mg, administered once daily. If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined

Sponsors & Collaborators

Principal Investigators

  • Yuri Rukazenkov · AstraZeneca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-03-04
Primary Completion
2015-05-01
Completion
2023-12-11

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • Japan
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

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 NCT01802632 on ClinicalTrials.gov