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ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

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Genzyme

Status and phase

Completed
Phase 3

Conditions

Non-Small-Cell Lung Carcinoma

Treatments

Other: Best Supportive Care
Drug: ZD6474 (vandetanib)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00404924
D4200C00044
EUDRACT Number 2006-002384-12

Details and patient eligibility

About

This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.

Enrollment

1,140 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with Non-small cell lung cancer for which the standard cancer treatments of surgery, chemotherapy, radiation or other anticancer drugs are no longer appropriate treatments for you.

Exclusion criteria

  • Patients who have had standard cancer treatments of surgery, chemotherapy or other systemic anti-cancer therapy within 4 weeks before start of study therapy.
  • Three or more prior chemotherapy regimens.
  • Significant cardiovascular events.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,140 participants in 2 patient groups, including a placebo group

1
Placebo Comparator group
Description:
Best Supportive Care
Treatment:
Other: Best Supportive Care
2
Experimental group
Description:
Vandetanib + Best Supportive Care
Treatment:
Other: Best Supportive Care
Drug: ZD6474 (vandetanib)

Trial contacts and locations

103

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Data sourced from clinicaltrials.gov

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