Clinical trial NCT00726752: A Study In Patients With Advanced Solid Tumor
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: solid tumor
Axitinib
Pharmacokinetics
Phase 1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses


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.

Primary outcomes:
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
measure: Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
measure: Single Dose: Plasma Decay Half-Life (t1/2)
timeFrame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
Secondary outcomes:
measure: Multiple Dose: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
measure: Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
timeFrame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
measure: Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
measure: Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)
timeFrame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
measure: 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 )
timeFrame: Prior to the initial dose (baseline) and Day 1 of Cycle 2
measure: 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)
timeFrame: Up to 470 days
measure: Number of Participants With Adverse Events
timeFrame: Up to 470 days of treatment plus 28-days follow-up
Other outcomes:
Locations:
city: Kobe-shi
country: Japan
facility: Pfizer Investigational Site
state: Hyogo-ken
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: