Phase 1
Completed N=36
First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors
Source: ClinicalTrials.gov NCT01469052 ↗Enrolled (actual)
36
Serious AEs
33.3%
Results posted
Mar 2012
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — 5 mg BID
Summary
The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
5 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
144.48; 97.81; 20.71; 88.16; 22.21; 19.75 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
2.00; 4.04; 4.00; 2.05; 1.52; 1.01 | — |
| SECONDARY Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] |
692.47; 564.56; 88.62; 473.26; 68.73; 61.92 | — |
| SECONDARY Apparent Oral Clearance (CL/F) |
19.80; 30.82; 53.17; 29.04; 71.82; 30.27 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
3.09; 3.29; 2.31; 3.08; 1.86; 3.77 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) in Fed State Versus Overnight Fasting |
— | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) in Fed State Versus Overnight Fasting |
— | — |
| SECONDARY Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] in Fed State Versus Overnight Fasting |
— | — |
| SECONDARY Apparent Oral Clearance (CL/F) in Fed State Versus Overnight Fasting |
— | — |
| SECONDARY Plasma Decay Half-Life (t1/2) in Fed State Versus Overnight Fasting |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with cytologically or histologically confirmed solid tumor(s) and with at least one measurable disease site
- Patients with adequate bone marrow, liver and kidney function
- Patients with life expectancy of at least 12 weeks
Exclusion Criteria
- Patients who have received chemotherapy, immunotherapy, radiotherapy or any investigational agent within 4 weeks of study entry
- Patients with have had a major surgical procedure within 4 weeks of study entry
Data sourced from ClinicalTrials.gov (NCT01469052). 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.