First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors

Pfizer36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors

Interventions

AG-013736DRUG

Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state

AG-013736DRUG

Axitinib continuous oral dosing (20 mg twice a day) in the fed state

AG-013736DRUG

Axitinib continuous oral dosing (5 mg twice a day) in the fed state

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Pfizer Investigational Site

San Francisco, California, United States

Pfizer Investigational Site

Houston, Texas, United States

Pfizer Investigational Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD)

MTD is defined as the dose level at which "no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD)." DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.

Time frame: Baseline up to Day 28

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Time frame: 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)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 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)

Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)]

AUC (0-12)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12).

Time frame: 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)

Apparent Oral Clearance (CL/F)

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.