Clinical trial NCT01469052: First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors
Official title: Phase I, Open-Label, Multicenter, Dose-Escalation Study Of The Tyrosine Kinase Inhibitor Of VEGFR-2, AG013736, In Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Baseline up to Day 28
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours (hrs) post-dose on Day (D) 1 and 15 of Cycle (C) 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
measure: Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)]
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
measure: Apparent Oral Clearance (CL/F)
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
measure: Maximum Observed Plasma Concentration (Cmax) in Fed State Versus Overnight Fasting
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) in Fed State Versus Overnight Fasting
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
measure: Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] in Fed State Versus Overnight Fasting
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
measure: Apparent Oral Clearance (CL/F) in Fed State Versus Overnight Fasting
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
measure: Plasma Decay Half-Life (t1/2) in Fed State Versus Overnight Fasting
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: