Assess safety & efficacy of selumetinib when given in combination with standard first line treatment for advanced Non-small Cell Lung Cancer - SELECT-3

Study identifier:D1532C00070

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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)

Medical condition

Locally Advanced or Metastatic NSCL Cancer stage IIIB IV

Phase

Phase 1

Healthy volunteers

Study drug

selumetinib, gemcitabine, cisplatin, carboplatin, pemetrexed

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 04 Apr 2013

Primary Completion Date: 04 Jan 2016

Study Completion Date: 04 Jan 2016

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Glasgow, United Kingdom, G12 0YN

Location

Research Site

London, United Kingdom, W1G 6AD

Location

Research Site

Manchester, United Kingdom, M20 4BX

Location

Research Site

Newcastle upon Tyne, United Kingdom, NE7 7DN

Arms	Assigned Interventions
Experimental: Selumetinib+standard chemotherapy Selumetinib plus gemcitabine; or pemetrexed and cisplatin or carboplatin	Drug: selumetinib 2 x 25mg capsules bd continuously in cohort 1 (with gemcitabine and cisplatin). If tolerated - next cohort 3 x 25mg capsules bd continuously. if higher doses are explored, required number of capsules will be provided. Option to administer on D2-19 of each 21 day cycle if required to assess tolerability of combinations with chemotherapy Drug: gemcitabine 1250 mg/m2 iv on Day 1 and 8 of each 21 day cycle. If combination not tolerated, option to give 1000 mg/m2 iv on Day 1 and Day 8 of each 21 day cycle Drug: cisplatin 75 mg/m2 iv on Day 1 of each 21 day cycle. If combination not tolerated, option to give 50 mg/m2 iv on Day 1 or 25mg/m2 iv on Day 1 and Day 8 of each 21 day cycle Drug: carboplatin If it is not possible to identify a tolerable combination of selumetinib, gemcitabine and cisplatin, cisplatin may be replaced with carboplatin (AUC5) iv on Day 1 of each 21 day cycle Drug: pemetrexed Gemcitabine may be replaced with pemetrexed 500 mg/m2 iv on Day 1 of each 21 day cycle.

Arms

Assigned Interventions

Experimental: Selumetinib+standard chemotherapy
Selumetinib plus gemcitabine; or pemetrexed and cisplatin or carboplatin

Drug: selumetinib
2 x 25mg capsules bd continuously in cohort 1 (with gemcitabine and cisplatin). If tolerated - next cohort 3 x 25mg capsules bd continuously. if higher doses are explored, required number of capsules will be provided. Option to administer on D2-19 of each 21 day cycle if required to assess tolerability of combinations with chemotherapy

Drug: gemcitabine
1250 mg/m2 iv on Day 1 and 8 of each 21 day cycle. If combination not tolerated, option to give 1000 mg/m2 iv on Day 1 and Day 8 of each 21 day cycle

Drug: cisplatin
75 mg/m2 iv on Day 1 of each 21 day cycle. If combination not tolerated, option to give 50 mg/m2 iv on Day 1 or 25mg/m2 iv on Day 1 and Day 8 of each 21 day cycle

Drug: carboplatin
If it is not possible to identify a tolerable combination of selumetinib, gemcitabine and cisplatin, cisplatin may be replaced with carboplatin (AUC5) iv on Day 1 of each 21 day cycle

Drug: pemetrexed
Gemcitabine may be replaced with pemetrexed 500 mg/m2 iv on Day 1 of each 21 day cycle.

Documents available

D1532C00070revisedCSP-2_Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Clinical Study Information

800-236-9933

Investigators

Principal Investigator

Gabriella Mariani

AstraZeneca UK, MSD

Assess safety & efficacy of selumetinib when given in combination with standard first line treatment for advanced Non-small Cell Lung Cancer - SELECT-3

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Documents available

D1532C00070revisedCSP-2_Redacted

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator