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A Phase I, Multi-Centre, Open-Label, Dose Selection Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Etoposide and Cisplatin (EP) as First Line Therapy for Lung Cancer Patients With Extensive Stage or Metastatic Disease for Whom EP Would be a Standard Therapy


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase I, Multi-Centre, Open-Label, Dose Selection Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Etoposide and Cisplatin (EP) as First Line Therapy for Lung Cancer Patients With Extensive Stage or Metastatic Disease for Whom EP Would be a Standard Therapy


Inclusion Criteria:



- Cancer diagnosis and stage (histological or cytological confirmed extensive stage
lung cancer, which EP would be considered a standard therapy, required at the time of
diagnosis.)

- No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior
radiotherapy will be permitted if it is outside of the measurable field and greater
than or equal to 2 weeks prior to entry to the study.)

- WHO performance status 0-2

Exclusion Criteria:

- Untreated unstable brain or meningeal metastases

- Patient with inappropriate laboratory tests values

- Inadequate bone marrow reserve.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP).

Outcome Time Frame:

From date of consent through to data cut-off, 7th August 2009.

Safety Issue:

Yes

Principal Investigator

John Heymach, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

D8480C00054

NCT ID:

NCT00621361

Start Date:

February 2008

Completion Date:

February 2012

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • AZD2171
  • cediranib
  • RECENTIN
  • etoposide
  • cisplatin
  • Lung Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteHays, Kansas  
Research SiteAbilene, Texas