NCT01469052

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2002

Geographic Reach
1 country

3 active sites

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

November 1, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

March 26, 2012

Status Verified

February 1, 2012

Enrollment Period

1.7 years

First QC Date

November 2, 2011

Results QC Date

February 25, 2012

Last Update Submit

February 25, 2012

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline up to Day 28

Secondary Outcomes (10)

  • Maximum Observed Plasma Concentration (Cmax)

    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)

    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)]

    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)

    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)

  • Plasma Decay Half-Life (t1/2)

    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)

  • +5 more secondary outcomes

Study Arms (6)

Cohort 1

EXPERIMENTAL
Drug: AG-013736

Cohort 2

EXPERIMENTAL
Drug: AG-013736

Cohort 3

EXPERIMENTAL
Drug: AG-013736

Cohort 4

EXPERIMENTAL
Drug: AG-013736

Cohort 5

EXPERIMENTAL
Drug: AG-013736

Cohort 6

EXPERIMENTAL
Drug: AG-013736

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

Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 10, 2011

Study Start

November 1, 2002

Primary Completion

July 1, 2004

Study Completion

August 1, 2004

Last Updated

March 26, 2012

Results First Posted

March 26, 2012

Record last verified: 2012-02

Locations

US(3)