NCT01006252

Brief Summary

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

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
336

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_3

Geographic Reach
17 countries

119 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

July 17, 2018

Completed
Last Updated

July 17, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

October 30, 2009

Results QC Date

March 17, 2018

Last Update Submit

June 18, 2018

Conditions

Melanoma

Keywords

metastaticsecond-line

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    OS is duration from enrollment to death; OS censored for participants who were alive at last contact.

    Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months

Secondary Outcomes (13)

  • Progression Free Survival (PFS)

    Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 months

  • Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR)

    First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months

  • Duration of Response (DoR) for Participants Having an Objective Response of Partial Response (PR) or Complete Response (CR)

    First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months

  • Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD)

    First date RECIST criteria met for CR, PR, or SD until first date of documented progressive disease (PD), or death from any cause (assessed every other cycle) up to 13.70 months

  • Time to Deterioration in the Functional Assessment of Cancer Therapy-Melanoma Trial Outcome Index (FACT-M TOI) Score

    Randomization to first date of deterioration in FACT-M TOI, or death from any cause (assessed every cycle and up to 30 days following treatment discontinuation) up to 13.21 months

  • +8 more secondary outcomes

Study Arms (2)

Tasisulam-sodium

EXPERIMENTAL

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.

Drug: Tasisulam-sodium

Paclitaxel

ACTIVE COMPARATOR

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

Drug: Paclitaxel

Interventions

Tasisulam-sodiumDRUG

Administered intravenously on Day 1 of a 28-day cycle, until disease progression.

Also known as: LY573636
Tasisulam-sodium
PaclitaxelDRUG

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

Paclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (122)

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Birmingham, Alabama, 35243, United States

Location

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Scottsdale, Arizona, 85258, United States

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Tucson, Arizona, 85724, United States

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Little Rock, Arkansas, 72205, United States

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Fresno, California, 93720, United States

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Los Angeles, California, 90025, United States

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San Francisco, California, 94115, United States

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Fort Myers, Florida, 33916, United States

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Jacksonville, Florida, 32207, United States

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Lakeland, Florida, 33805, United States

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Orlando, Florida, 32806, United States

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West Palm Beach, Florida, 33401, United States

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Augusta, Georgia, 30901, United States

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Chicago, Illinois, 60611, United States

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Park Ridge, Illinois, 60068, United States

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Goshen, Indiana, 46526, United States

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Indianapolis, Indiana, 46260, United States

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Iowa City, Iowa, 52242, United States

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Westwood, Kansas, 66205, United States

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Wichita, Kansas, 67214, United States

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Louisville, Kentucky, 40402, United States

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Baton Rouge, Louisiana, 70809, United States

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Minneapolis, Minnesota, 55455, United States

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Rochester, Minnesota, 55905, United States

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Columbia, Missouri, 65203, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68198, United States

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Las Vegas, Nevada, 89135, United States

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Morristown, New Jersey, 07960, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27157, United States

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Fargo, North Dakota, 58122, United States

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Cincinnati, Ohio, 45236, United States

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Cleveland, Ohio, 44106, United States

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Columbus, Ohio, 43219, United States

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Toledo, Ohio, 43623, United States

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Bethlehem, Pennsylvania, 18015, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Charleston, South Carolina, 29425, United States

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Columbia, South Carolina, 29210, United States

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Rapid City, South Dakota, 57701, United States

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Memphis, Tennessee, 38138, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75390, United States

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La Porte, Texas, 77571, United States

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The Woodlands, Texas, 77380, United States

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Salt Lake City, Utah, 84106, United States

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Richmond, Virginia, 23230, United States

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Seattle, Washington, 98109, United States

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Madison, Wisconsin, 53717, United States

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Coffs Harbour, New South Wales, 2450, Australia

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Wollongong, New South Wales, 2500, Australia

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Townsville, Queensland, 4810, Australia

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Woolloongabba, Queensland, 4102, Australia

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Nedlands, Western Australia, 6009, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Vienna, A1090, Austria

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Antwerp, 2020, Belgium

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Brussels, 1200, Belgium

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Leuven, 3000, Belgium

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Edmonton, Alberta, T6G 1Z2, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Tampere, 33520, Finland

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Turku, 20520, Finland

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Bordeaux, 33075, France

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Dijon, 21034, France

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Grenoble, 38049, France

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Marseille, 13385, France

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Nantes, 44093, France

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Paris, 75475, France

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Toulouse, 31059, France

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Villejuif, 94805, France

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Berlin, 10117, Germany

Location

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Buxtehude, 21614, Germany

Location

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Cologne, 50937, Germany

Location

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Essen, D-45147, Germany

Location

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Hanover, 30449, Germany

Location

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Heilbronn, D-74078, Germany

Location

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Kiel, 24105, Germany

Location

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Mainz, 55131, Germany

Location

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München, 80337, Germany

Location

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Münster, 48157, Germany

Location

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Quedlinburg, 06484, Germany

Location

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Tübingen, 72076, Germany

Location

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Jerusalem, 91120, Israel

Location

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Tel Aviv, 64239, Israel

Location

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Tel Litwinsky, 52661, Israel

Location

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Genova, 16132, Italy

Location

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Milan, 20141, Italy

Location

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Napoli, 80131, Italy

Location

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Padua, 35128, Italy

Location

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Siena, 53100, Italy

Location

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Leiden, 2300 RC, Netherlands

Location

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Maastricht, 6229 HX, Netherlands

Location

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Rotterdam, 3015 GD, Netherlands

Location

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Oslo, 0310, Norway

Location

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Trondheim, 7006, Norway

Location

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Bialystok, 15-027, Poland

Location

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Gdansk, 80-952, Poland

Location

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Otwock, 05-400, Poland

Location

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Poznan, 61-866, Poland

Location

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Goyang-si, 411-764, South Korea

Location

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Seoul, 110-744, South Korea

Location

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Barcelona, 08036, Spain

Location

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Madrid, 28046, Spain

Location

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Pamplona, 31008, Spain

Location

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Valencia, 46014, Spain

Location

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Malmo, 20502, Sweden

Location

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Stockholm, 11883, Sweden

Location

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Changhua, 500, Taiwan

Location

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Niao Sung Hsiang, 83301, Taiwan

Location

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Taipei, 100, Taiwan

Location

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Taoyuan District, 333, Taiwan

Location

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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

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London, Greater London, SW3 6JJ, United Kingdom

Location

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Southampton, Hants, SO16 6YD, United Kingdom

Location

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Hampstead, London, NW3 2QG, United Kingdom

Location

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Northwood, Middlesex, HA6 2RN, United Kingdom

Location

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Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Interventions

N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamidePaclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 17, 2018

Results First Posted

July 17, 2018

Record last verified: 2018-06

Locations

PL(4)IT(5)CA(4)ES(4)SE(2)NL(3)NO(2)BE(3)GB(6)FI(2)FR(8)IL(3)KR(2)TW(4)AU(5)DE(12)US(50)