Brief Summary

The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Dec 2006

Longer than P75 for phase_2

Geographic Reach

9 countries

26 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

5.8 years study duration

First Submitted

Initial submission to the registry

October 16, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed

1 month until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

November 25, 2013

Completed

Last Updated

November 25, 2013

Status Verified

September 1, 2013

Enrollment Period

5.8 years

First QC Date

October 16, 2006

Results QC Date

September 24, 2013

Last Update Submit

September 24, 2013

Conditions

Thyroid Neoplasms

Keywords

VEGFR inhibitortyrosine kinase inhibitoranti-angiogeniccarcinomapapillaryfollicularmedullaryanaplastic

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (\>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study \>=4 weeks after initial documentation of response.
Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)

Secondary Outcomes (5)

Progression Free Survival (PFS)
Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)
Duration of Response (DR)
Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)
Overall Survival (OS)
Baseline to death due to any cause or at least 2 year after the first dose for the last participant
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score
Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score
Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)

Study Arms (1)

A

EXPERIMENTAL

Drug: AG-013736

Interventions

AG-013736DRUG

AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer
At least 1 measurable target lesion, as defined by RECIST

You may not qualify if:

Thyroid lymphoma
Previous treatment with anti-angiogenesis agents
No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism within 12 months prior.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (26)

Pfizer Investigational Site

Orange, California, 92868, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80010, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33612, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60637-1470, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67226, United States

Location

Pfizer Investigational Site

Witchita, Kansas, 67220, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14263, United States

Location

Pfizer Investigational Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 4L6, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 4M1, Canada

Location

Pfizer Investigational Site

Nanjing, Jiangsu, 210002, China

Location

Pfizer Investigational Site

Beijing, 100021, China

Location

Pfizer Investigational Site

Shanghai, 20001/200127, China

Location

Pfizer Investigational Site

Shanghai, 200233, China

Location

Pfizer Investigational Site

Prague, 150 06, Czechia

Location

Pfizer Investigational Site

Vellore, Tamil Nadu, 632 004, India

Location

Pfizer Investigational Site

Milan, 20133, Italy

Location

Pfizer Investigational Site

Pisa, 56124, Italy

Location

Pfizer Investigational Site

Gliwice, 44-101, Poland

Location

Pfizer Investigational Site

Warsaw, 02-781, Poland

Location

Pfizer Investigational Site

Madrid, Madrid, 28033, Spain

Location

Pfizer Investigational Site

Pamplona, Navarre, 31008, Spain

Location

Pfizer Investigational Site

Glasgow, G12 0YN, United Kingdom

Location

Related Publications (1)

Locati LD, Licitra L, Agate L, Ou SH, Boucher A, Jarzab B, Qin S, Kane MA, Wirth LJ, Chen C, Kim S, Ingrosso A, Pithavala YK, Bycott P, Cohen EE. Treatment of advanced thyroid cancer with axitinib: Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments. Cancer. 2014 Sep 1;120(17):2694-703. doi: 10.1002/cncr.28766. Epub 2014 May 20.
PMID: 24844950DERIVED

MeSH Terms

Conditions

Thyroid NeoplasmsCarcinoma

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

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.

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 2
Allocation: NON RANDOMIZED
Masking: NONE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 18, 2006

Study Start

December 1, 2006

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 25, 2013

Results First Posted

November 25, 2013

Record last verified: 2013-09

Locations

CA(3)CN(4)IN(1)IT(2)ES(2)GB(1)US(10)CZ(1)PL(2)

Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations