Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

NCT00094107 | Completed Phase 2 Results DMC

• 1 other identifier: A4061015
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 12

Brief Summary

This is a Phase 2 study being conducted at multiple centers in the United States and France. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage.

Conditions

Melanoma; Skin Neoplasms

Keywords

melanoma; antiangiogenesis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response (OR)

  Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses 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 147 weeks

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 147 weeks

• Duration of Response (DR)

  Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 147 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 147 weeks

• Plasma Concentrations of Soluble Proteins

  Day 1 (pre-dose) and then every 8 weeks up to 147 weeks

Study Arms (1)

Axitinib [AG-013736]

EXPERIMENTAL

Drug: Axitinib [AG-013736]

Interventions

Axitinib [AG-013736] DRUG

VEGFR \[vascular endothelial growth factor Receptor\] and PDGFR \[Platelet-Derived Growth Factor Receptor\] inhibitor: Single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs.

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 melanoma with metastases
• No more than 1 prior systemic therapy for metastatic disease (prior adjuvant therapy with interferon does not count as prior therapy for metastatic disease)

You may not qualify if:

• History of hemoptysis (coughing up of blood)
• Brain metastases

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

Pfizer Investigational Site

Orange, California, 92868, United States

Location

Pfizer Investigational Site

Miami Beach, Florida, 33140, 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

Clairton, Pennsylvania, 15025, United States

Location

Pfizer Investigational Site

Greensburg, Pennsylvania, 15601, United States

Location

Pfizer Investigational Site

Johnstown, Pennsylvania, 15901, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15232-1305, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15232, United States

Location

Pfizer Investigational Site

Wexford, Pennsylvania, 15090, United States

Location

Pfizer Investigational Site

Paris, 75651, France

Location

Related Links

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

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue 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 pharmacokinetic 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 11, 2004
• First Posted: October 14, 2004
• Study Start: December 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 26, 2012
• Results First Posted: March 30, 2012

Record last verified: 2012-06

Locations

FR (1); US (11)