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

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Orange, California, 92868 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma, Skin Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- History of hemoptysis (coughing up of blood)

- Brain metastases

NCT00094107
Pfizer
Completed
Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

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Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma
Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Melanoma
  • Skin Neoplasms
Drug: Axitinib [AG-013736]
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.
Experimental: Axitinib [AG-013736]
Intervention: Drug: Axitinib [AG-013736]
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • History of hemoptysis (coughing up of blood)
  • Brain metastases
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   United States
 
 
NCT00094107
A4061015
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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