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Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

A STUDY OF OVERVIDA PHASE III DOUBLE BLIND CONTROLLED WITH PLACEBO, PARALLEL GROUPS, MULTICENTER, RANDOMIZED, COMPARING ZD1839 (IRESSA) (250MGCOMPROMIDO) PLUS THE BEST PALLIATIVE CARE VERSUS PLACEBO PLUS THE BEST PALLIATIVE CARE IN PATIENTS WITH ADVANCED CPCNP THAT HAVE RECEIVED 1 OR 2 PRIOR CHEMOTHERAPY TUMORS AND ARE REFRACTORY OR INTOLERANT TO THEIR MOST RECENT REGIMES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-021-04
Enrollment
Unknown
Registered
2004-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

ZD1839 Type of group
ZD1839 is administered until unacceptable toxicity appears Group name:placebo Type of group
Placebo of ZD1839 is administered until acceptable toxicity appears

Sponsors

ASTRAZENECA UK LTD.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: · Life expectancy of at least 8 weeks. Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma Not suitable for chemotherapy WHO Performance status 0,1, 2 or 3

Exclusion criteria

Exclusion criteria: Newly diagnosed CNS mets Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity ALT/AST greater than 5 x upper limit of normal ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Design outcomes

Primary

MeasureTime frame
Outcome name:overall surviva Measure:to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care Timepoints:12 month—

Secondary

MeasureTime frame
Outcome name:time to therapeutic failure Measure:ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure Timepoints:12 month—

Countries

Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Estonia, Germany, Greece, Hungary, India, Ireland, Latvia, Lithuania, Malasya, Mexico, Netherlands, Norway, Philippines, Poland, Romania, Russian Federation, Singapore, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, Venezuela

Outcome results

None listed

Source: REPEC (via WHO ICTRP)