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Sponsored by: |
Hana Biosciences, Inc |
Information provided by: | Hana Biosciences, Inc |
ClinicalTrials.gov Identifier: | NCT00506142 |
Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growing and spreading throughout the body. This may cause the cancer cells to die. Liposomal vincristine is formed when vincristine is placed inside of oil droplets called liposomes, which may help to improve the delivery of drug to the tumor site. The liposomal formulation results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer cells to vincristine continuously.
The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be studied.
Up to 30 patients will take part in this study.
Condition | Intervention | Phase |
Metastatic Malignant Uveal Melanoma |
Drug: Marqibo® (vincristine sulfate liposomes injection) |
Phase II |
Genetics Home Reference related topics: | retinoblastoma |
MedlinePlus related topics: | Cancer Melanoma |
ChemIDplus related topics: | Vincristine sulfate Vincristine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma |
Estimated Enrollment: | 30 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lucy Prasad | 650-228-5014 | lucy.prasad@hanabiosciences.com |
United States, Pennsylvania | |||||
Thomas Jefferson University | Recruiting | ||||
Philadelphia, Pennsylvania, United States, 19107 | |||||
Contact: Mary Ann Laudadio 215-955-9980 mary.ann.laudadio@jefferson.edu | |||||
Principal Investigator: Takami Sato, MD | |||||
United States, Texas | |||||
University of Texas M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Principal Investigator: Agop Bedikian, MD |
Hana Biosciences, Inc |
Responsible Party: | Hana Biosciences, Inc. ( Michael Imperiale, MD, VP Clinical Research Operations ) |
Study ID Numbers: | HBS408 (formerly IST401) |
First Received: | July 23, 2007 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00506142 |
Health Authority: | United States: Food and Drug Administration |
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