Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer

NCT00094055 | Completed Phase 2 Results

• 1 other identifier: A4061014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 9

Brief Summary

This is a Phase 2 study being conducted at multiple centers in the United States. Patients having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that was not controlled by previous treatment with radioactive iodine (131I) or not be good candidates for such treatment. The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic thyroid cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage.

Conditions

Thyroid Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response (OR)

  Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

  Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks

• Duration of Response (DR)

  Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks

• Overall Survival (OS)

  Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant

Other Outcomes (2)

• Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations

  Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 206 weeks

• Plasma Concentrations of Soluble Proteins

  Day 1 (pre-dose) and then every 8 weeks up to 206 weeks

Study Arms (1)

Axitinib [AG-013736]

EXPERIMENTAL

Drug: AG013736

Interventions

AG013736 DRUG

AG013736, tablets 5 mg BID daily until tumor progression or toxicity

Axitinib [AG-013736]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented thyroid cancer with metastases.
• Failure of radioactive iodine (131I) to control the disease or radioactive iodine (131I) is not an appropriate therapy (e.g. due to lack of iodine uptake by the tumor)

You may not qualify if:

• Central lung lesions involving major blood vessels (arteries or veins).(Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
• Patients with a history of hemoptysis

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Pfizer Investigational Site

Santa Monica, California, 90404, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80010, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80220, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60637, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21231-1000, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 51231, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Cohen EE, Tortorici M, Kim S, Ingrosso A, Pithavala YK, Bycott P. A Phase II trial of axitinib in patients with various histologic subtypes of advanced thyroid cancer: long-term outcomes and pharmacokinetic/pharmacodynamic analyses. Cancer Chemother Pharmacol. 2014 Dec;74(6):1261-70. doi: 10.1007/s00280-014-2604-8. Epub 2014 Oct 15.

  PMID: 25315258 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Population pharmacokinetics and plasma concentrations of soluble proteins were not presented, as the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.

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

Study Record Dates

• First Submitted: October 8, 2004
• First Posted: October 11, 2004
• Study Start: September 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 26, 2012
• Results First Posted: March 30, 2012

Record last verified: 2012-06

Locations

US (9)