NCT00726752

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

July 30, 2008

Results QC Date

February 25, 2012

Last Update Submit

May 17, 2012

Conditions

Neoplasms

Keywords

solid tumorAxitinibPharmacokineticsPhase 1

Outcome Measures

Primary Outcomes (4)

  • Single Dose: Maximum Observed Plasma Concentration (Cmax)

    Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)

    AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).

    Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose

  • Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose

  • Single Dose: Plasma Decay Half-Life (t1/2)

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose

Secondary Outcomes (7)

  • Multiple Dose: Maximum Observed Plasma Concentration (Cmax)

    Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose

  • Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

    Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose

  • Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose

  • Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)

    Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose

  • 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 )

    Prior to the initial dose (baseline) and Day 1 of Cycle 2

  • +2 more secondary outcomes

Study Arms (1)

Axitinib

EXPERIMENTAL
Drug: Axitinib (AG-013736)

Interventions

Axitinib (AG-013736)DRUG

Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.

Axitinib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Axitinib

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 1, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 23, 2012

Results First Posted

March 26, 2012

Record last verified: 2012-05

Locations

JP(1)