A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma
NCT ID: NCT01006252
Last Updated: 2018-07-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
336 participants
INTERVENTIONAL
2009-12-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tasisulam-sodium
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
Tasisulam-sodium
Administered intravenously on Day 1 of a 28-day cycle, until disease progression.
Paclitaxel
Paclitaxel 80 milligrams per square meter (mg/m\^2) administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
Paclitaxel
80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
Interventions
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Tasisulam-sodium
Administered intravenously on Day 1 of a 28-day cycle, until disease progression.
Paclitaxel
80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have the presence of evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
* Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
* Have progressed after 1 previous systemic treatment containing dacarbazine or temozolomide for metastatic melanoma.
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia).
* Have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) or greater than or equal to 30 grams per liter (g/L).
Exclusion Criteria
* Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. Participants with a history of a solitary CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) and not requiring steroids are eligible.
* Are receiving warfarin.
* Have primary ocular or mucosal melanoma.
* Any previous treatment with paclitaxel or a paclitaxel-containing regimen for metastatic melanoma.
* Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
* Have previously completed or withdrawn from this study or any other study investigating tasisulam-sodium.
* Have a known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil).
* Are pregnant or lactating.
* Have received a recent (within 30 days before enrollment) or are receiving concurrent yellow fever vaccination.
* Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
* Are unable to withhold dosing of non-steroidal anti-inflammatory drugs (NSAIDs) or proton-pump inhibitors (PPIs) for at least 72 hours before and after treatment with tasisulam-sodium.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Nantes, , France
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Paris, , France
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Toulouse, , France
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Villejuif, , France
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Berlin, , Germany
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Buxtehude, , Germany
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Cologne, , Germany
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Essen, , Germany
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Hanover, , Germany
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Heilbronn, , Germany
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Kiel, , Germany
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Mainz, , Germany
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München, , Germany
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Münster, , Germany
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Quedlinburg, , Germany
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Tübingen, , Germany
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Jerusalem, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Genova, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Siena, , Italy
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Leiden, , Netherlands
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Oslo, , Norway
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Trondheim, , Norway
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Bialystok, , Poland
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Gdansk, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Goyang-si, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Valencia, , Spain
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Malmo, , Sweden
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Stockholm, , Sweden
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Changhua, , Taiwan
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Niao Sung Hsiang, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Cambridge, Cambridgeshire, United Kingdom
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London, Greater London, United Kingdom
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Southampton, Hants, United Kingdom
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Hampstead, London, United Kingdom
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Northwood, Middlesex, United Kingdom
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Manchester, , United Kingdom
Countries
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Other Identifiers
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H8K-MC-JZAO
Identifier Type: OTHER
Identifier Source: secondary_id
13101
Identifier Type: -
Identifier Source: org_study_id
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