Clinical trial · Interventional
Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
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
NCT00127829CI-TRIAL-00002242AGUScompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Gefitinib (IRESSA®)
- interventionNames
- Drug: Gefitinib
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed solid tumor refractory to conventional treatment or whom no standard of treatment exists * Life expectancy of \> 12 weeks * World Health Organization (WHO) performance status of \< 2 Exclusion Criteria: * Known severe hypersensitivity to gefitinib or any of the excipients of this product * Less than 4 weeks since completion of prior chemotherapy or radiation therapy (except nitrosoureas or mitomycin-C which must have a wash out period of 6 weeks) * Incomplete healing from previous oncologic or other major surgery
References
Publications (0)
Data not yet available
No reference posted for this study.