Clinical trial · Interventional
Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients
A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
NCT00569114CI-TRIAL-00003271completedPhase 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 is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TG01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- interventionNames
- Drug: TG01
Primary outcomes (1)
- measure
- Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
- timeFrame
- Baseline, 8, 15 and 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (include but are not limited to): * Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC. * Measurable or evaluable disease as defined by RECIST * Must have failed at least one prior chemotherapy regimen or have refused chemotherapy. * ECOG perfromance status of 0,1, or 2. Exclusion Criteria (include but are not limited to): * Radiation therapy (excluding CNS therapy) \< 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier. * Evidence of New York Heart Associatation Class III or greater cardiac disease. * History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months. * Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin. * Systemic central nervous system metastases. The patient must be stable after radiotherapy for \>/= to 2 weeks and off corticosteroids for \>/= to 1 week. * Pregnant or nursing women. * Patients who are primarily refactory to erlotinib.
References
Publications (0)
Data not yet available
No reference posted for this study.