Study of Selumetinib in Patients With Previously Treated or Untreated Advanced/Metastatic NSCLC

Sponsor
Canadian Cancer Trials Group
Study ID
NCT01783197
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
  • Carboplatin — DRUG
  • Selumetinib — DRUG
  • Pemetrexed — DRUG
  • Cisplatin — DRUG

Study Details

This research is being done because further research on selumetinib in combination with standard chemotherapy treatment is needed. Although the number of treatment options for patients with advanced non-small cell lung cancer has increased over the past decade, prognosis remains poor, and there is a need for additional therapeutic options.

Key Dates

Start date
Jun 4, 2013
Status verified
Apr 2020
Primary completion
Apr 18, 2017
Completion
Apr 2, 2019

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Paclitaxel and carboplain plus selumetinib
    Cohort 1: Standard Chemotherapy (paclitaxel and carboplatin) plus selumetinib If you are registered to Cohort 1, you will receive two commonly-used chemotherapy drugs called paclitaxel and carboplatin, plus you will be given the experimental drug selumetinib.
  • Experimental: pemetrexed and cisplain plus selumetinib
    Cohort 2: Standard Chemotherapy (pemetrexed and cisplatin) plus selumetinib (cohort closed) If you are registered to Cohort 2, you will receive two commonly-used chemotherapy drugs called pemetrexed and cisplatin, plus you will be given the experimental drug selumetinib.
  • Experimental: pemetrexed plus selumetinib
    Cohort 3: Standard Chemotherapy (pemetrexed) plus selumetinib (cohort closed) If you are registered to Cohort 3, you will receive one commonly-used chemotherapy drug called pemetrexed, plus you will be given the experimental drug selumetinib.

Primary Outcome Measure

Maximum dose tolerability of Selumetinib in patients [ Time Frame: 24 months ]

Related Studies