Clinical trial NCT00447005: Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
Official title: A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Keywords: Safety
PK
Biomarker
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-13
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.


Eligibility criteria: Inclusion Criteria:

* Patients histologically or cytologically diagnosed with advanced malignant solid tumors
* Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies

Exclusion Criteria:

* Central lung lesions involving major blood vessels
* Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 795 days of treatment plus 28-days follow-up
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax): Single Dose
timeFrame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose
timeFrame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
measure: Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose
timeFrame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
measure: Terminal Phase Plasma Half-Life (t1/2): Single Dose
timeFrame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax): Multiple Dose
timeFrame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose
timeFrame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
measure: Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose
timeFrame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
measure: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose
timeFrame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
measure: Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)
timeFrame: Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation
measure: The Numbers 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 795 days
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Pfizer Investigational Site
state: Chiba
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Mukohara T, Nakajima H, Mukai H, Nagai S, Itoh K, Umeyama Y, Hashimoto J, Minami H. Effect of axitinib (AG-013736) on fatigue, thyroid-stimulating hormone, and biomarkers: a phase I study in Japanese patients. Cancer Sci. 2010 Apr;101(4):963-8. doi: 10.1111/j.1349-7006.2009.01465.x. Epub 2009 Dec 9.