Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00066196|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : January 15, 2008
The primary objectives of this study are:
- To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic melanoma.
- To determine the safety of MEDI-522 ± DTIC in this patient population.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Malignant Metastatic Melanoma||Biological: MEDI--522 Biological: Integrin + Dacarbazine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Randomized, Open-Label Study Evaluating The Antitumor Activity Of MEDI-522, A Humanized Monoclonal Antibody Directed Against The Human Alpha V Beta 3 Integrin, ± Dacarbazine In Patients With Metastatic Melanoma|
|Study Start Date :||August 2003|
|Estimated Primary Completion Date :||April 2007|
|Actual Study Completion Date :||June 2007|
Integrin + Dacarbazine
Biological: Integrin + Dacarbazine
supplied in other formulations
Active Comparator: 1
IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.
- Explore antitumor activity of MEDI-522 in patients with metastatic melanoma. [ Time Frame: Screening and after every 2 cycles of treatment until disease progression. At least 4 weeks after a patient demonstrates response. ]
- Determine the safety of MEDI-522 and/or DTIC in this patient population. [ Time Frame: Every week until disease progression, and 30 days after disease progression. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066196
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|Study Director:||Luz Hammershaimb, M.D.||MedImmune LLC|