NCT01809210 - Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 4, 2013

Primary Completion Date

January 4, 2016

Study Completion Date

January 4, 2016

Conditions

Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV

Interventions

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.

Trial Locations (4)

G12 0YN

Research Site, Glasgow

W1G 6AD

Research Site, London

M20 4BX

Research Site, Manchester

NE7 7DN

Research Site, Newcastle upon Tyne