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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00127829 |
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.
Condition | Intervention | Phase |
---|---|---|
Tumors |
Drug: Gefitinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase I, Open-Label, Dose Escalation Study Evaluating High-Dose Gefitinib (IRESSA®) on Weekly and Twice Weekly Schedules in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic |
Estimated Enrollment: | 66 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Gefitinib (IRESSA®)
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Drug: Gefitinib
Oral tablet
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Clincal Information Center | 1-800-236-9933 | information.center@astrazeneca.com |
United States, California | |
Research Site | Recruiting |
Los Angeles, California, United States | |
Research Site | Recruiting |
Palm Springs, California, United States |
Responsible Party: | AstraZeneca ( Alison Armour, MD, IRESSA Medical Science Director ) |
Study ID Numbers: | D7913C00022 |
Study First Received: | August 5, 2005 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00127829 |
Health Authority: | United States: Food and Drug Administration |
Solid Tumors |
Gefitinib Recurrence |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |