Status:
COMPLETED
Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief 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 d...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Provision of signed, written and dated 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)
- Female patients must not be breast-feeding and have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential
- Patients must be eligible to receive treatment with the platinum doublet combination with which selumetinib is being combined and in accordance with the local product information
Exclusion
- Prior chemotherapy or other systemic anti-cancer treatment for advanced NSCLC.
- Prior surgery or radiotherapy within 6 months or palliative radiotherapy within 4 weeks of start of study treatment.
- Female patients who are breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- Another primary malignancy within 5 years of starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ.
- As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection
Key Trial Info
Start Date :
April 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2016
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01809210
Start Date
April 4 2013
End Date
January 4 2016
Last Update
March 13 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Glasgow, United Kingdom, G12 0YN
2
Research Site
London, United Kingdom, W1G 6AD
3
Research Site
Manchester, United Kingdom, M20 4BX
4
Research Site
Newcastle upon Tyne, United Kingdom, NE7 7DN