Clinical trial · Interventional
A Study In Patients With Advanced Solid Tumor
A Phase 1 Study In Patients With Advanced Solid Tumor To Evaluate The Pharmacokinetics And Safety Of AG-013736 At Single Doses Of 5 mg, 7 mg And 10 mg, And At Multiple Doses
NCT00726752CI-TRIAL-00006978completedPhase 1Results postedClinicalTrials.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 designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axitinib (AG-013736) | Drug | Axitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Axitinib
- interventionNames
- Drug: Axitinib (AG-013736)
Primary outcomes (4)
- measure
- Single Dose: Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
- measure
- Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)
- timeFrame
- Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
- description
- AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).
- measure
- Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients histologically or cytologically diagnosed with advanced solid tumors * Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2 * Patients with no uncontrolled hypertension Exclusion Criteria: * Patients who have central lung lesions involving major blood vessels * Patients who require anticoagulant therapy. * Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.
References
Publications (0)
Data not yet available
No reference posted for this study.