Phase 1
Completed N=6
A Study In Patients With Advanced Solid Tumor
Neoplasms
Source: ClinicalTrials.gov NCT00726752 ↗
Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Mar 2012
Primary outcomePrimary: Single Dose: Maximum Observed Plasma Concentration (Cmax) — 20.732; 32.007; 53.123 ng/mL
Summary
This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Single Dose: Maximum Observed Plasma Concentration (Cmax) |
20.732; 32.007; 53.123 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf) |
180.25; 228.45; 379.12 | — |
| PRIMARY Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) |
4.1000; 4.0000; 4.0150 | — |
| PRIMARY Single Dose: Plasma Decay Half-Life (t1/2) |
4.778; 5.088; 5.880 | — |
| SECONDARY Multiple Dose: Maximum Observed Plasma Concentration (Cmax) |
25.933 | — |
| SECONDARY Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) |
164.55 | — |
| SECONDARY Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) |
4.0400 | — |
| SECONDARY Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau) |
1.3540; 1.4185 | — |
| SECONDARY Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT ) |
-29.15; -33.16; -56.38; -14.59; 179.52 | — |
| SECONDARY Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) |
0; 0; 3; 3 | — |
| SECONDARY Number of Participants With Adverse Events |
6; 1; 4; 1; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00726752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.