MelanomaPhase 3SUMMIT-1NCT01006252

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

A Phase 3 study testing Tasisulam-sodium and Paclitaxel in people with Melanoma, run by Eli Lilly and Company at 122 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma
What is being tested?: Tasisulam-sodium and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 336 participants
Where: 122 sitesin 18 countries
Study dates: Dec 2009to Mar 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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).

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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.

Trial locations and contacts

122 sites in 18 countries.

Country

City, postcode or hospital

122 sites in 18 countries

United States50 sites

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Augusta, Georgia, 30901
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Baton Rouge, Louisiana, 70809
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Bethlehem, Pennsylvania, 18015
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Birmingham, Alabama, 35243
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Charleston, South Carolina, 29425
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Chicago, Illinois, 60611
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Cincinnati, Ohio, 45236
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Cleveland, Ohio, 44106
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Columbia, Missouri, 65203
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Columbia, South Carolina, 29210
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Columbus, Ohio, 43219
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Dallas, Texas, 75390
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Durham, North Carolina, 27710
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Fargo, North Dakota, 58122
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Fort Myers, Florida, 33916
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Fresno, California, 93720
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Goshen, Indiana, 46526
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Indianapolis, Indiana, 46260
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32207
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La Porte, Texas, 77571
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Lakeland, Florida, 33805
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Las Vegas, Nevada, 89135
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Little Rock, Arkansas, 72205
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Los Angeles, California, 90025
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Louisville, Kentucky, 40402
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Madison, Wisconsin, 53717
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Memphis, Tennessee, 38138
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Minneapolis, Minnesota, 55455
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Morristown, New Jersey, 07960
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Nashville, Tennessee, 37203
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Omaha, Nebraska, 68198
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Orlando, Florida, 32806
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Park Ridge, Illinois, 60068
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Pittsburgh, Pennsylvania, 15232
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Rapid City, South Dakota, 57701
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Richmond, Virginia, 23230
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Rochester, Minnesota, 55905
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Salt Lake City, Utah, 84106
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San Francisco, California, 94115
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Scottsdale, Arizona, 85258
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Seattle, Washington, 98109
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St Louis, Missouri, 63110
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The Woodlands, Texas, 77380
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Toledo, Ohio, 43623
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Tucson, Arizona, 85724
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West Palm Beach, Florida, 33401
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Westwood, Kansas, 66205
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Wichita, Kansas, 67214
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Winston-Salem, North Carolina, 27157

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Germany12 sites

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Berlin, 10117
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Buxtehude, 21614
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Cologne, 50937
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Essen, D-45147
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Hanover, 30449
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Heilbronn, D-74078
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Kiel, 24105
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Mainz, 55131
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München, 80337
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Münster, 48157
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Quedlinburg, 06484
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Tübingen, 72076

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France8 sites

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Bordeaux, 33075
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Dijon, 21034
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Grenoble, 38049
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Marseille, 13385
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Nantes, 44093
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Paris, 75475
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Toulouse, 31059
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Villejuif, 94805

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United Kingdom6 sites

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Cambridge, Cambridgeshire, CB2 0QQ
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Hampstead, London, NW3 2QG
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London, Greater London, SW3 6JJ
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Manchester, M20 4BX
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Northwood, Middlesex, HA6 2RN
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Southampton, Hants, SO16 6YD

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Australia5 sites

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Coffs Harbour, New South Wales, 2450
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Nedlands, Western Australia, 6009
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Townsville, Queensland, 4810
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Wollongong, New South Wales, 2500
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Woolloongabba, Queensland, 4102

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Italy5 sites

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Genova, 16132
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Milan, 20141
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Naples, 80131
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Padova, 35128
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Siena, 53100

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Canada4 sites

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Edmonton, Alberta, T6G 1Z2
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Hamilton, Ontario, L8V 5C2
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Montreal, Quebec, H3A 1A1
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Toronto, Ontario, M5G 2M9

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Poland4 sites

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Bialystok, 15-027
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Gdansk, 80-952
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Otwock, 05-400
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Poznan, 61-866

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Spain4 sites

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Barcelona, 08036
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Madrid, 28046
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Pamplona, 31008
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Valencia, 46014

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Taiwan4 sites

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Changhua, 500
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Niao Sung Hsiang, 83301
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Taipei, 100
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Taoyuan, 333

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Austria3 sites

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Graz, 8036
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Innsbruck, 6020
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Vienna, A1090

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Belgium3 sites

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Antwerp, 2020
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Brussels, 1200
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Leuven, 3000

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Israel3 sites

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Jerusalem, 91120
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Tel Aviv, 64239
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Tel HaShomer, 52661

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Netherlands3 sites

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Leiden, 2300 RC
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Maastricht, 6229 HX
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Rotterdam, 3015 GD

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Finland2 sites

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Tampere, 33520
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Turku, 20520

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Norway2 sites

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Oslo, 0310
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Trondheim, 7006

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South Korea2 sites

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Goyang-si, 411-764
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Seoul, 110-744

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Sweden2 sites

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Malmö, 20502
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Stockholm, 11883

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About this study

Official title: A Randomized Phase 3 Study of Tasisulam-sodium Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle Versus Paclitaxel as Second-line Treatment in Patients With Metastatic Melanoma

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

Conditions: Melanoma
Being tested: Tasisulam-sodium, Paclitaxel
Keywords: metastatic, second-line
Medical subject headings: Melanoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tasisulam-sodiumDrug
Also called LY573636
Administered intravenously on Day 1 of a 28-day cycle, until disease progression.
PaclitaxelDrug
80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Study groups in NCT01006252
Study group	Role	What they receive
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. Receives: 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 Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival (OS)
OS is duration from enrollment to death; OS censored for participants who were alive at last contact.
Measured: 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)
PFS is time from date of first dose to first observation of disease progression (PD); PD=20% increase in sum of the longest diameter of target lesions, or death from any cause.
Measured: 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)
Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions.
Measured: 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)
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions. Analysis was adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group. Due to limited number of responses for either treatment arm, DoR analysis was not performed.
Measured: 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)
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria; PD=20% increase in sum of the longest diameter of target lesions.
Measured: 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
FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. FACT-M TOI is the sum of FACT-M physical well-being, functional well-being, and melanoma subscales. Scores range from 0 to 120; Higher scores=better quality of life (QoL). FACT-M TOI score deterioration was defined as time from randomization to a minimally important difference in TOI score or death.
Measured: 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
Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation
FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Measured: Baseline at Cycle 2, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation
FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Measured: Baseline at Cycle 3, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation
FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Measured: Baseline at Cycle 4, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation
EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe the status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Measured: Baseline at Cycle 2, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 3 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation
EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Measured: Baseline at Cycle 3, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation
EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Measured: Baseline at Cycle 4, up to 30 days after treatment discontinuation
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) During Cycle 1
Measured: After drug infusion in Cycle 1 (5 samples drawn over the 28-day cycle)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2
Measured: After drug infusion in Cycle 2 (2 samples drawn over the 28-day cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Mar 2011

First posted2 Nov 2009 (estimated)
Study startDec 2009
Primary completionMar 2011
Study completionMar 2011

Why it stopped: More possibly treatment-related deaths on tasisulam-sodium arm.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MelanomaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 336 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01006252
Sponsor's protocol ID: 13101
Other IDs: H8K-MC-JZAO
Acronym: SUMMIT-1
Status last verified: Jun 2018
First submitted: 30 Oct 2009
Last updated: 17 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

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What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase 3 Study of Tasisulam-sodium Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle Versus Paclitaxel as Second-line Treatment in Patients With Metastatic Melanoma
ClinicalTrials.gov ID: NCT01006252
Acronym / sponsor ID: SUMMIT-1 / 13101
Conditions: Melanoma
Keywords: metastatic, second-line
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: More possibly treatment-related deaths on tasisulam-sodium arm.
Enrolment: 336 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 2 Nov 2009 (estimated)
Results: Posted 17 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tasisulam-sodium	Experimental	Drug: Tasisulam-sodiumIndividualized 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.
Paclitaxel	Active comparator	Drug: PaclitaxelPaclitaxel 80 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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).

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tasisulam-sodiumAlso: LY573636Administered intravenously on Day 1 of a 28-day cycle, until disease progression.	Drug	Tasisulam-sodium
Paclitaxel80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression	Drug	Paclitaxel

Primary outcome

Overall Survival (OS)
Time frame: Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months
OS is duration from enrollment to death; OS censored for participants who were alive at last contact.

13 secondary outcomes

Progression Free Survival (PFS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation
Time frame: Baseline at Cycle 2, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation
Time frame: Baseline at Cycle 3, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation
Time frame: Baseline at Cycle 4, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation
Time frame: Baseline at Cycle 2, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 3 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation
Time frame: Baseline at Cycle 3, up to 30 days following treatment discontinuation
Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation
Time frame: Baseline at Cycle 4, up to 30 days after treatment discontinuation
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) During Cycle 1
Time frame: After drug infusion in Cycle 1 (5 samples drawn over the 28-day cycle)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2
Time frame: After drug infusion in Cycle 2 (2 samples drawn over the 28-day cycle)

Results and safety

Results posted to the registry on 17 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tasisulam-sodium	168	168
Paclitaxel	168	168

Primary outcome: Overall Survival (OS)

Time frame: Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months. Median (95% Confidence Interval). Unit: months

Measure	Tasisulam-sodium n = 168	Paclitaxel n = 168
Value	6.77 (5.88 to 8.28)	9.36 (6.90 to NA)

Tasisulam-sodium vs Paclitaxel: Hazard Ratio (HR): 1.23, p = 0.121, Stratified log rank

Population analysed: The intent-to-treat (ITT) analysis population included all participants randomized to treatment.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tasisulam-sodium	53 of 164 (32.3%)	149 of 164 (90.9%)	Not reported
Paclitaxel	44 of 161 (27.3%)	146 of 161 (90.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

122 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tasisulam-sodium and Paclitaxel in people with Melanoma, run by Eli Lilly and Company at 122 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, Germany, France, United Kingdom, Australia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01006252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.