Phase 2
N=32
Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma
Melanoma · Skin Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00094107 ↗Enrolled (actual)
32
Serious AEs
56.3%
Results posted
Mar 2012
Primary outcome: Primary: Percentage of Participants With Objective Response (OR) — 18.8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Axitinib [AG-013736] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
18.8 | — |
| SECONDARY Progression-free Survival (PFS) |
117.5 | — |
| SECONDARY Duration of Response (DR) |
179.0 | — |
| SECONDARY Overall Survival (OS) |
200.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00094107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.