A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma

NCT ID: NCT01006252

Last Updated: 2018-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-03-31

Brief Summary

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The primary purpose of this study was to see how tasisulam-sodium affected metastatic melanoma when compared against paclitaxel as measured by overall survival.

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Tasisulam-sodium

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

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.

Intervention Type DRUG

Paclitaxel

80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Intervention Type DRUG

Other Intervention Names

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LY573636

Eligibility Criteria

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Inclusion Criteria

* Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV).
* 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 received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen (including biologic agents and vaccination-based treatments), or treatment with a targeted agent (for example, BRAF or c-Kit inhibitor is not counted as a prior treatment regimen for determining study eligibility, unless either was combined with a cytotoxic drug).
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Birmingham, Alabama, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Fresno, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Park Ridge, Illinois, United States

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Goshen, Indiana, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Westwood, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Morristown, New Jersey, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Bethlehem, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Rapid City, South Dakota, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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La Porte, Texas, United States

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The Woodlands, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Coffs Harbour, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Townsville, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Nedlands, Western Australia, Australia

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Graz, , Austria

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Innsbruck, , Austria

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Antwerp, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Edmonton, Alberta, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Tampere, , Finland

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Turku, , Finland

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Bordeaux, , France

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Dijon, , France

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Grenoble, , France

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Marseille, , France

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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

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Countries

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United States Australia Austria Belgium Canada Finland France Germany Israel Italy Netherlands Norway Poland South Korea Spain Sweden Taiwan United Kingdom

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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