CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 55 enrolled
Drug / intervention
selumetinib +4 moredrug
Likely dose
selumetinib 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01809210
NCT01809210Phase 1Completed
CompareCT.gov

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)

AstraZeneca·interventional·Posted Mar 12, 2013·Updated Mar 13, 2018

In Brief

A Phase 1 clinical trial evaluating selumetinib, gemcitabine, and 3 other interventions for Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV. Completed, enrolled 55 participants across 4 sites.

Detailed Summary

This is a Phase I, open label multicentre study of selumetinib administered orally in combination with first line chemotherapy regimens to patients with advanced/metastatic NSCLC. The study has been designed to allow an investigation of the optimal dose of selumetinib in combination with various standard first line double-platinum chemotherapy regimens. Initial assessment will be based on tolerability of selumetinib in combination with one or more selected regimens that are considered to be tolerated also being assessed for preliminary evidence of activity. This study is a dose finding and optional cohort expansion; In addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced or Metastatic NSCL Cancer Stage IIIB IV
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2013
Enrollment StartApr 4, 2013
Primary CompletionJan 4, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.3 years ago

Interventions

selumetinibdrug

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

gemcitabinedrug

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

cisplatindrug

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

carboplatindrug

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

pemetrexeddrug

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