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A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma (SUMMIT-1)

Primary Purpose

Melanoma

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tasisulam-sodium

Paclitaxel

About this trial

This is an interventional treatment trial for Melanoma focused on measuring metastatic, second-line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tasisulam-sodium

Paclitaxel

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Overall Survival (OS)

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

Secondary Outcome Measures

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) During Cycle 1

Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2

Full Information

NCT ID

NCT01006252

First Posted

October 30, 2009

Last Updated

June 18, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01006252

Brief Title

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

Acronym

SUMMIT-1

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Terminated

Why Stopped

More possibly treatment-related deaths on tasisulam-sodium arm.

Study Start Date

December 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

metastatic, second-line

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

336 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tasisulam-sodium

Arm Type

Experimental

Arm Description

Arm Title

Paclitaxel

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tasisulam-sodium

Other Intervention Name(s)

LY573636

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

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

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

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

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.

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

Title

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

Description

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

Title

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

Description

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

Title

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)

Description

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

Title

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

Description

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

Title

Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation

Description

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.

Time Frame

Baseline at Cycle 2, up to 30 days following treatment discontinuation

Title

Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation

Description

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.

Time Frame

Baseline at Cycle 3, up to 30 days following treatment discontinuation

Title

Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation

Description

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.

Time Frame

Baseline at Cycle 4, up to 30 days following treatment discontinuation

Title

Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation

Description

Time Frame

Baseline at Cycle 2, up to 30 days following treatment discontinuation

Title

Change From Baseline at Cycle 3 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation

Description

Time Frame

Baseline at Cycle 3, up to 30 days following treatment discontinuation

Title

Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation

Description

Time Frame

Baseline at Cycle 4, up to 30 days after treatment discontinuation

Title

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)

Title

Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2

Time Frame

After drug infusion in Cycle 2 (2 samples drawn over the 28-day cycle)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35243

Country

United States

Facility Name

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30901

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

City

Goshen

State/Province

Indiana

ZIP/Postal Code

46526

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40402

Country

United States

Facility Name

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65203

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89135

Country

United States

Facility Name

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07960

Country

United States

Facility Name

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43219

Country

United States

Facility Name

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29210

Country

United States

Facility Name

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

City

La Porte

State/Province

Texas

ZIP/Postal Code

77571

Country

United States

Facility Name

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53717

Country

United States

Facility Name

City

Coffs Harbour

State/Province

New South Wales

ZIP/Postal Code

2450

Country

Australia

Facility Name

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2500

Country

Australia

Facility Name

City

Townsville

State/Province

Queensland

ZIP/Postal Code

4810

Country

Australia

Facility Name

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

City

Vienna

ZIP/Postal Code

A1090

Country

Austria

Facility Name

City

Antwerp

ZIP/Postal Code

2020

Country

Belgium

Facility Name

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

City

Grenoble

ZIP/Postal Code

38049

Country

France

Facility Name

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

City

Buxtehude

ZIP/Postal Code

21614

Country

Germany

Facility Name

City

Essen

ZIP/Postal Code

D-45147

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30449

Country

Germany

Facility Name

City

Heilbronn

ZIP/Postal Code

D-74078

Country

Germany

Facility Name

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

City

Muenchen

ZIP/Postal Code

80337

Country

Germany

Facility Name

City

Muenster

ZIP/Postal Code

48157

Country

Germany

Facility Name

City

Quedlinburg

ZIP/Postal Code

06484

Country

Germany

Facility Name

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

City

Tel Hashomer

ZIP/Postal Code

52661

Country

Israel

Facility Name

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

City

Goyang-Si

ZIP/Postal Code

411-764

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

City

Leiden

ZIP/Postal Code

2300 RC

Country

Netherlands

Facility Name

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

City

Oslo

ZIP/Postal Code

0310

Country

Norway

Facility Name

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

City

Bialystok

ZIP/Postal Code

15-027

Country

Poland

Facility Name

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

City

Otwock

ZIP/Postal Code

05-400

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

61-866

Country

Poland

Facility Name

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

City

Malmo

ZIP/Postal Code

20502

Country

Sweden

Facility Name

City

Stockholm

ZIP/Postal Code

11883

Country

Sweden

Facility Name

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

City

Niao Sung Hsiang

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

City

Tao-Yuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

City

London

State/Province

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

City

Southampton

State/Province

Hants

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

City

Hampstead

State/Province

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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