Clinical trial · Interventional
Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors
NCT02447419CI-TRIAL-00059128completedPhase 2ClinicalTrials.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 is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors. Gefitinib 250 mg will be administered orally daily. To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gefitinib
- description
- Gefitinib 250 mg will be administered orally daily
- interventionNames
- Drug: Gefitinib
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- up too 100 weeks
Secondary outcomes (3)
- measure
- progression-free survival
- timeFrame
- expected average of 24 weeks
- measure
- overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of fully informed consent prior to any study specific procedures. 2. Patients must be ≥20 years of age. 3. Patient with Epidermal growth factor receptor amplification Refractory Solid Tumors and/or specific sensitivity to Gefitinib by Avatar scan that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy. (EGFR amplification by cancer scan + EGFR IHC overexpression +2 or +3) 4. ECOG performance status 0-2. 5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator. 6. Adequate Organ Function Laboratory Values * Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L * bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases) * creatinine ≤1.5 x UNL 7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing. 8. Adequate heart function. Exclusion Criteria: 1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years. 2. Has known active central nervous system (CNS) metastases. 3. Has an active infection requiring systemic therapy. 4. Pregnancy or breast feeding 5. Patients with cardiac problem. 6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600) 7. Any previous treatment with Gefitinib 8. Patients with a risk factor of interstitial lung disease
References
Publications (1)
- DERIVEDByeon S, Hong JY, Lee J, Nam DH, Park SH, Park JO, Park YS, Lim HY, Kang WK, Kim ST. Use of Gefitinib in EGFR-Amplified Refractory Solid Tumors: An Open-Label, Single-Arm, Single-Center Prospective Pilot Study. Target Oncol. 2020 Apr;15(2):185-192. doi: 10.1007/s11523-020-00706-0. PMID 32107712