Completed

SELECT-3A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination With First Line Chemotherapy Regimens in Patients With Non-Small Cell Lung Cancer (NSCLC)

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What is being tested

selumetinib

+ gemcitabine

+ cisplatin

Drug
Who is being recruted

Bronchial Neoplasms+11

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 99 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: March 13, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: April 4, 2013

Actual date on which the first participant was enrolled.

A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination with First Line Chemotherapy Regimens in Patients with Non-Small Cell Lung Cancer (NSCLC)

NCT01809210
Principal SponsorAstraZeneca
Last updated: March 13, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

55 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesRespiratory Tract DiseasesRespiratory Tract NeoplasmsPathological Conditions, Signs and SymptomsThoracic NeoplasmsCarcinoma, Non-Small-Cell LungNeoplasm Metastasis

Criteria

5 inclusion criteria required to participate
Female patients must not be breast-feeding and have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential
Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
Male or female, aged 18 years or older
Patients must be eligible to receive treatment with the platinum doublet combination with which selumetinib is being combined and in accordance with the local product information
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5 exclusion criteria prevent from participating
Another primary malignancy within 5 years of starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ
As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection
Female patients who are breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
Prior chemotherapy or other systemic anti-cancer treatment for advanced NSCLC
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Selumetinib plus gemcitabine; or pemetrexed and cisplatin or carboplatin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Research Site

Glasgow, United KingdomOpen Research Site in Google Maps

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Newcastle upon Tyne, United Kingdom
Completed4 Study Centers