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A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABI-007
Dacarbazine
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring Melanoma, Malignant, Abraxane, ABI-007, Dacarbazine, Dtic-Dome

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed cutaneous malignant melanoma with evidence of metastasis (Stage IV).
  • No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. Prior treatment with kinase inhibitors or cytokines is permitted.
  • No prior adjuvant cytotoxic chemotherapy is permitted. Prior adjuvant therapy with interferon, Granulocyte-macrophage colony-stimulating factor (GM-CSF) and/or vaccines is permitted.
  • Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta human chorionic gonadotropin (ß-hCG) within 72 hours prior to first study drug administration. If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
  • No other current active malignancy within the past 3 years.
  • Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion
  • Patient has the following blood counts at Baseline:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 cells/L;
  • platelets ≥ 100 x 10^9 cells/L;
  • Hemoglobin (Hgb) ≥ 9 g/dL.
  • Patient has the following blood chemistry levels at Baseline:
  • Aspartate aminotransferase(AST) glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5x upper limit of normal range (ULN); ≤ 5.0 xULN if hepatic metastases present;
  • total bilirubin ≤ ULN;
  • creatinine ≤ 1.5 mg/dL.
  • Lactate Dehydrogenase (LDH) ≤ 2.0 x ULNa
  • Expected survival of > 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria:

  • History of or current evidence of brain metastases, including leptomeningeal involvement.
  • Patient has pre-existing peripheral neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.
  • Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
  • Patient has a clinically significant concurrent illness.
  • Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
  • Patient is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. Marker studies or studies evaluating biological correlates are permitted.
  • Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.

Sites / Locations

  • University of Alabama at Birmingham
  • AZ Cancer Ctr
  • Arizona Cancer Center
  • Genesis Cancer Ctr - Hot Springs
  • University of Arkansa for Medical Sciences
  • Tower Cancer Research Foundation
  • San Diego Pacific Oncology and Hematology Associates
  • Loma Linda University Cancer Center
  • University of Southern California/Norris Cancer Center
  • University of CA Los Angeles
  • St. Mary's Medical Center
  • University of Colorado Cancer Center
  • Baptist Cancer Institute
  • Lakeland Regional Cancer Center
  • University of Miami Hospital and Clincs/SCCC
  • Waren Billhartz Cancer Center
  • Indiana University
  • IA Blood and Cancer Care, PLC
  • Beth Israel Deaconess Medical Center
  • Wayne State University
  • University of Minnesota
  • Saint Louis University
  • St. John's Medical Research
  • Nevada Cancer Institute
  • Atlantic Melanoma Center
  • Piedmont Hematology
  • OH State University Arthur G. James Cancer Hospital
  • Integris Cancer Institute of OK
  • St. Luke's Hospital & Health Network
  • Thomas Jefferson University
  • Mary Crowley Research Center
  • Univ of TX MD Anderson Cancer Ctr
  • Univ of TX Med School at Houston
  • Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center
  • Hope Oncology
  • Utah Cancer Specialist
  • Univ. of Washington Medical Center/Seattle Cancer Care Alliance
  • Evergreen Hematology & Oncology
  • Port Macquarie Base Hospital
  • Royal North Shore Hospital
  • Sydney West Cancer Trials Centre/Westmead Hospital
  • Royal Adelaide Hospital, Department of Medical Oncology
  • Royal Hobart Hospital
  • Alfred Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • BCCA Centre for the Southern Interior
  • BCCA, Centre for the Southern Interior
  • BC Cancer Agency-Fraser Valley Ctr.
  • BC Cancer Agency-Vancouver
  • BC Cancer Agency-Vancouver Island Ctr.
  • London Regional Cancer Program
  • Credit Valley Hospital
  • The Ottawa Hospital Regional Cancer Centre
  • Sunnybrook Health Sciences Centre
  • McGill University Dept. of Oncology Clinical Research Program
  • Hopital Saint Andre' CHU de Bordeaux
  • Centre Hospitaller Universitaire de Grenoble
  • CHRU Hopital Claude Huriez
  • Hopital Dypuytren-CHU de Limoges
  • Centre Leon Berad
  • Hopital Sainte Marguerite
  • CHU Hopital Saint Eloi
  • Centre Regional Val d' Aurelle Paul Lamarque
  • Hopital de 1 Archet 2
  • Hopital Saint-Louis
  • Hopital Bichat
  • Groupe hospitalier Cochin-St. Vincent de Paul
  • Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc
  • Charite Universitaetsmedizin Berlin
  • Universitaetsklinkum Heidelberg
  • Universitaetsklinkum Heidelberg
  • Universitaetsklinkum Tuebingen
  • Universitaetsklinkum Wuerzburg PS
  • Universitaetsklinkum Hamburg-Eppendorf
  • Univeritaetsklinkum Goettingen
  • Medizinische Hochschuke Hannover
  • St. Josef-Hospital
  • Universitaetsklinkum Essen
  • Universitaetklinkum Koeln
  • Universitaetsklinkum Schegwig-Holstein
  • Universitaetsklinkum Dresden
  • UniversitawtsklinKum Jena
  • Universitaesklinkum Leipzig
  • Universitaetsklinkum Mainz
  • Istituto Tumori "Giovanni Paolo II"
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei T
  • IST-Istituto Nazionale per la Ricera sul Cancro
  • Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori
  • IOV-Instituto Oncologico IRCCS
  • Azienda Ospedaliera Universitaria Sense
  • Ist. Naz. per lo studio e la cura dei tumori G. Pascale
  • Ospedale S. Chiara
  • Medisch Centrum Alkmaar
  • Rijnstate ziekenhuis Arnhem
  • Erasmus MC ae" Daniel den Hoed
  • H Clinic i Provincial
  • H CLINIC I Provincial
  • H Clinico San Carlos
  • Corporacion Sanitaria Parc Tauli
  • Broomfield Hospital
  • Velindre Hospital
  • St. George's Hospital
  • Nottingham University Hospitals NHS Trust
  • Singleton Hospital, Sothwest Wales Inst.
  • Univ Hospital of North Staffordshire
  • Weston Park Hospital
  • Newcross Hospital
  • Royal Marsden Hospital London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABI-007

Dacarbazine

Arm Description

Treatment Arm A (ABI-007): Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.

Treatment Arm B (dacarbazine): Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines
PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free. RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.

Secondary Outcome Measures

Participant Survival
Survival was defined as the time from the date of randomization to the date of death (any cause). Participants were censored at the last known time that they were alive.
Summary of Treatment-emergent Adverse Events (AEs)
A Treatment Emergent AE (TEAE) was any AE that began or worsened after the start of the study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AE's were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 3.0 criteria and the following scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, and Grade 5 = Death A SAE is any untoward medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug
The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Nadir for the Absolute Neutrophil Count (ANC) Measurements
Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.
Nadir for White Blood Cells (WBCs) Measurements
Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.
Nadir for Platelet Count Measurements.
Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.
Nadir for the Hemoglobin Count Measurements
Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.
Pharmacokinetic Parameters

Full Information

First Posted
March 16, 2009
Last Updated
October 16, 2019
Sponsor
Celgene
Collaborators
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT00864253
Brief Title
A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
Official Title
An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 23, 2009 (Actual)
Primary Completion Date
June 1, 2012 (Actual)
Study Completion Date
February 12, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
Collaborators
University of Arizona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
Melanoma, Malignant, Abraxane, ABI-007, Dacarbazine, Dtic-Dome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
529 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABI-007
Arm Type
Experimental
Arm Description
Treatment Arm A (ABI-007): Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.
Arm Title
Dacarbazine
Arm Type
Active Comparator
Arm Description
Treatment Arm B (dacarbazine): Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.
Intervention Type
Drug
Intervention Name(s)
ABI-007
Other Intervention Name(s)
Abraxane
Intervention Description
Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Other Intervention Name(s)
Dtic-Dome, DTIC-Dome
Intervention Description
Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines
Description
PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free. RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.
Time Frame
Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012
Secondary Outcome Measure Information:
Title
Participant Survival
Description
Survival was defined as the time from the date of randomization to the date of death (any cause). Participants were censored at the last known time that they were alive.
Time Frame
Up to 38 months; Up to data cut off of 30 June 2012
Title
Summary of Treatment-emergent Adverse Events (AEs)
Description
A Treatment Emergent AE (TEAE) was any AE that began or worsened after the start of the study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AE's were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 3.0 criteria and the following scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, and Grade 5 = Death A SAE is any untoward medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Time Frame
Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012
Title
Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug
Description
The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Time Frame
Maximum study drug exposure 106 weeks; data cut off 30 June 2012
Title
Nadir for the Absolute Neutrophil Count (ANC) Measurements
Description
Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.
Time Frame
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Title
Nadir for White Blood Cells (WBCs) Measurements
Description
Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.
Time Frame
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Title
Nadir for Platelet Count Measurements.
Description
Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.
Time Frame
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Title
Nadir for the Hemoglobin Count Measurements
Description
Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.
Time Frame
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Title
Pharmacokinetic Parameters
Time Frame
On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose
Other Pre-specified Outcome Measures:
Title
Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines
Description
PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, patients who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free.
Time Frame
Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months
Title
Percent of Participants Who Achieve an Objective Confirmed Complete or Partial Response Based on Blinded Radiology Assessment of Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
Description
RECIST defines complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
Time Frame
every 8 weeks; up to data cut off 30 June 2012
Title
Percent of Participants With Stable Disease (SD) for ≥ 16 Weeks, or Confirmed Complete or Partial Response (i.e., Disease Control) Based on a Blinded Radiology Assessment of Response
Description
Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #4 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
Time Frame
Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012
Title
Duration of Response (DOR) in Responding Participants
Description
Duration of response (DOR) as measured by PFS based on radiological review for participants who achieved an objective confirmed response of CR or PR. DOR was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or participants death from any cause, whichever occurred first. Participants that did not have progression or had not died were censored at the last known time the participant was progression free. Participants that had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) are defined in outcome #4. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Time Frame
up to data cut off 30 June 2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed cutaneous malignant melanoma with evidence of metastasis (Stage IV). No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. Prior treatment with kinase inhibitors or cytokines is permitted. No prior adjuvant cytotoxic chemotherapy is permitted. Prior adjuvant therapy with interferon, Granulocyte-macrophage colony-stimulating factor (GM-CSF) and/or vaccines is permitted. Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta human chorionic gonadotropin (ß-hCG) within 72 hours prior to first study drug administration. If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator. No other current active malignancy within the past 3 years. Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion Patient has the following blood counts at Baseline: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 cells/L; platelets ≥ 100 x 10^9 cells/L; Hemoglobin (Hgb) ≥ 9 g/dL. Patient has the following blood chemistry levels at Baseline: Aspartate aminotransferase(AST) glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5x upper limit of normal range (ULN); ≤ 5.0 xULN if hepatic metastases present; total bilirubin ≤ ULN; creatinine ≤ 1.5 mg/dL. Lactate Dehydrogenase (LDH) ≤ 2.0 x ULNa Expected survival of > 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities. Exclusion Criteria: History of or current evidence of brain metastases, including leptomeningeal involvement. Patient has pre-existing peripheral neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed. Patient has a clinically significant concurrent illness. Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit. Patient is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. Marker studies or studies evaluating biological correlates are permitted. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Hersh, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ileana Elias, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
AZ Cancer Ctr
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Genesis Cancer Ctr - Hot Springs
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
University of Arkansa for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
San Diego Pacific Oncology and Hematology Associates
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of Southern California/Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of CA Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
St. Mary's Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
University of Miami Hospital and Clincs/SCCC
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Waren Billhartz Cancer Center
City
Maryville
State/Province
Illinois
ZIP/Postal Code
62062
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IA Blood and Cancer Care, PLC
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52402
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. John's Medical Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Atlantic Melanoma Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Piedmont Hematology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
OH State University Arthur G. James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Integris Cancer Institute of OK
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73142
Country
United States
Facility Name
St. Luke's Hospital & Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
Mary Crowley Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Univ of TX MD Anderson Cancer Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ of TX Med School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Hope Oncology
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Utah Cancer Specialist
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Univ. of Washington Medical Center/Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Evergreen Hematology & Oncology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Sydney West Cancer Trials Centre/Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Adelaide Hospital, Department of Medical Oncology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands Perth
State/Province
Western Australia
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BCCA Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BCCA, Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BC Cancer Agency-Fraser Valley Ctr.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
BC Cancer Agency-Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z4E6
Country
Canada
Facility Name
BC Cancer Agency-Vancouver Island Ctr.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Credit Valley Hospital
City
Missiauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
The Ottawa Hospital Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University Dept. of Oncology Clinical Research Program
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Hopital Saint Andre' CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Hospitaller Universitaire de Grenoble
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU Hopital Claude Huriez
City
Lile Cedax
Country
France
Facility Name
Hopital Dypuytren-CHU de Limoges
City
Limoges cedex
Country
France
Facility Name
Centre Leon Berad
City
Lyon
Country
France
Facility Name
Hopital Sainte Marguerite
City
Marseille Cedex 9
Country
France
Facility Name
CHU Hopital Saint Eloi
City
Montepellier Cedex 5
Country
France
Facility Name
Centre Regional Val d' Aurelle Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital de 1 Archet 2
City
Nice Cedex 3
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Saint-Louis
City
Paris Cedex
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Groupe hospitalier Cochin-St. Vincent de Paul
City
Paris
Country
France
Facility Name
Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Charite Universitaetsmedizin Berlin
City
Berlin
State/Province
BE
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinkum Heidelberg
City
Heidelberg
State/Province
BW
Country
Germany
Facility Name
Universitaetsklinkum Heidelberg
City
Heidelber
State/Province
BW
Country
Germany
Facility Name
Universitaetsklinkum Tuebingen
City
Tuebingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinkum Wuerzburg PS
City
Wuerzburg
State/Province
BY
ZIP/Postal Code
97080
Country
Germany
Facility Name
Universitaetsklinkum Hamburg-Eppendorf
City
Hamburg
State/Province
HH
Country
Germany
Facility Name
Univeritaetsklinkum Goettingen
City
Gottington
State/Province
NI
Country
Germany
Facility Name
Medizinische Hochschuke Hannover
City
Hannover
State/Province
NI
ZIP/Postal Code
30625
Country
Germany
Facility Name
St. Josef-Hospital
City
Bochum
State/Province
Northwest
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitaetsklinkum Essen
City
Essen
State/Province
Northwest
Country
Germany
Facility Name
Universitaetklinkum Koeln
City
Koln
State/Province
Northwest
Country
Germany
Facility Name
Universitaetsklinkum Schegwig-Holstein
City
Keil
State/Province
SH
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinkum Dresden
City
Dresden
State/Province
SN
Country
Germany
Facility Name
UniversitawtsklinKum Jena
City
Jena
State/Province
Strasse 35
ZIP/Postal Code
07743
Country
Germany
Facility Name
Universitaesklinkum Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitaetsklinkum Mainz
City
Mainz
Country
Germany
Facility Name
Istituto Tumori "Giovanni Paolo II"
City
Bari
State/Province
BA
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei T
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
IST-Istituto Nazionale per la Ricera sul Cancro
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale Tumori
City
Milano
State/Province
MI
Country
Italy
Facility Name
IOV-Instituto Oncologico IRCCS
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Sense
City
Siena
State/Province
SI
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ist. Naz. per lo studio e la cura dei tumori G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale S. Chiara
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
ZIP/Postal Code
1815
Country
Netherlands
Facility Name
Rijnstate ziekenhuis Arnhem
City
Amhem
ZIP/Postal Code
6800TA
Country
Netherlands
Facility Name
Erasmus MC ae" Daniel den Hoed
City
Rotterdam
Country
Netherlands
Facility Name
H Clinic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
H CLINIC I Provincial
City
Barcelona
Country
Spain
Facility Name
H Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Corporacion Sanitaria Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Broomfield Hospital
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Velindre Hospital
City
Cardiff
State/Province
Glam
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
GT Lon
ZIP/Postal Code
SW12 ORE
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nott
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Singleton Hospital, Sothwest Wales Inst.
City
Swansea
State/Province
S Glam
ZIP/Postal Code
SA28QA
Country
United Kingdom
Facility Name
Univ Hospital of North Staffordshire
City
Stroke On Kent
State/Province
Staffs
ZIP/Postal Code
ST4 6QB
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
Syorks
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Newcross Hospital
City
Wolverhampton
State/Province
Wstmid
ZIP/Postal Code
SV10 0QP
Country
United Kingdom
Facility Name
Royal Marsden Hospital London
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26410620
Citation
Hersh EM, Del Vecchio M, Brown MP, Kefford R, Loquai C, Testori A, Bhatia S, Gutzmer R, Conry R, Haydon A, Robert C, Ernst S, Homsi J, Grob JJ, Kendra K, Agarwala SS, Li M, Clawson A, Brachmann C, Karnoub M, Elias I, Renschler MF, Hauschild A. A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naive patients with metastatic melanoma. Ann Oncol. 2015 Nov;26(11):2267-74. doi: 10.1093/annonc/mdv324. Epub 2015 Sep 26.
Results Reference
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Learn more about this trial

A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

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