Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
Sponsor: AstraZeneca
ClinicalTrials ID:NCT01933932
This Phase III, double-blind, randomized study evaluates selumetinib with docetaxel versus placebo with docetaxel in KRAS mutation-positive NSCLC patients. Eligible participants are adults with advanced NSCLC who failed first-line therapy. Interventions include selumetinib or placebo capsules twice daily, docetaxel IV every 21 days, and pegylated G-CSF post-docetaxel.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
Description
A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)
Eligibility Criteria
Inclusion Criteria
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Male or female, aged 18 years or older
- Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
- KRAS mutation positive tumour sample as determined by the designated testing laboratory
- Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
Exclusion Criteria
- Mixed small cell and non-small cell lung cancer histology.
- Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
- Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
- Other concomitant anti-cancer therapy agents excepts steroids
- Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
- Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 80045 | Aurora | Colorado |
| Research Site | 33028 | Pembroke Pines | Florida |
| Research Site | 30318 | Atlanta | Georgia |
| Research Site | 60637 | Chicago | Illinois |
| Research Site | 70006 | Metairie | Louisiana |
| Research Site | 02114 | Boston | Massachusetts |
| Research Site | 02215 | Boston | Massachusetts |
| Research Site | 01923 | Danvers | Massachusetts |
| Research Site | 10011 | New York | New York |
| Research Site | 10032 | New York | New York |
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