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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00864253




Registration number
NCT00864253
Ethics application status
Date submitted
16/03/2009
Date registered
17/03/2009
Date last updated
24/04/2017

Titles & IDs
Public title
A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
Scientific title
An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
Secondary ID [1] 0 0
CA033
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma 0 0
Malignant Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABI-007
Treatment: Drugs - Dacarbazine
Treatment: Drugs - ABI-007
Treatment: Drugs - Dacarbazine

Experimental: ABI-007 - 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.

Active Comparator: Dacarbazine - 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.

Experimental: ABI-007 - 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.

Active Comparator: Dacarbazine - 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.


Treatment: Drugs: 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: Drugs: 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.

Treatment: Drugs: 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: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 38 months; Up to data cut off of 30 June 2012
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Maximum study drug exposure 106 weeks; data cut off 30 June 2012
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Secondary outcome [6] 0 0
Nadir for Platelet Count Measurements. - Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.
Timepoint [6] 0 0
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Secondary outcome [8] 0 0
Pharmacokinetic Parameters
Timepoint [8] 0 0
On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Up to 38 months; Up to data cut off of 30 June 2012
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Maximum study drug exposure 106 weeks; data cut off 30 June 2012
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Secondary outcome [14] 0 0
Nadir for Platelet Count Measurements. - Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.
Timepoint [14] 0 0
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Secondary outcome [16] 0 0
Pharmacokinetic Parameters
Timepoint [16] 0 0
On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney West Cancer Trials Centre/Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Adelaide Hospital, Department of Medical Oncology - Adelaide
Recruitment hospital [5] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Nedlands Perth
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
- Nedlands Perth
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
State/province [3] 0 0
Arkansas
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State/province [4] 0 0
California
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Colorado
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Florida
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Illinois
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State/province [8] 0 0
Indiana
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United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
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Minnesota
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Missouri
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Nevada
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New Jersey
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United States of America
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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United States of America
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Texas
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Utah
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United States of America
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Washington
Country [23] 0 0
Canada
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Alberta
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Canada
State/province [24] 0 0
British Columbia
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Canada
State/province [25] 0 0
Ontario
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Canada
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Quebec
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France
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Bordeaux
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France
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Grenoble Cedex 09
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France
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Lile cedax
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France
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Limoges cedex
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France
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Lyon
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France
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Marseille Cedex 9
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France
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Montepellier Cedex 5
Country [34] 0 0
France
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Montpellier
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France
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Nice Cedex 3
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France
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Paris Cedex
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France
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Paris
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France
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Villejuif Cedex
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Germany
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BE
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Germany
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BW
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Germany
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BY
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Germany
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HH
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Germany
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NI
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Germany
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NW
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Germany
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SH
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Germany
State/province [46] 0 0
SN
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Germany
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Strasse 35
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Germany
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Leipzig
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Germany
State/province [49] 0 0
Mainz
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Italy
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BA
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Italy
State/province [51] 0 0
FC
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Italy
State/province [52] 0 0
GE
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Italy
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MI
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Italy
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PD
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Italy
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SI
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Italy
State/province [56] 0 0
Napoli
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Italy
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Pisa
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Netherlands
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Alkmaar
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Netherlands
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Amhem
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Netherlands
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Rotterdam
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sabadell
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United Kingdom
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Essex
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United Kingdom
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Glam
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United Kingdom
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GT Lon
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United Kingdom
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Nott
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United Kingdom
State/province [68] 0 0
S Glam
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United Kingdom
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Staffs
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United Kingdom
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Syorks
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United Kingdom
State/province [71] 0 0
Wstmid
Country [72] 0 0
United Kingdom
State/province [72] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Arizona
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Arizona
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00864253
Trial related presentations / publications
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-naïve patients with metastatic melanoma. Ann Oncol. 2015 Nov;26(11):2267-74. doi: 10.1093/annonc/mdv324. Epub 2015 Sep 26.
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-naïve patients with metastatic melanoma. Ann Oncol. 2015 Nov;26(11):2267-74. doi: 10.1093/annonc/mdv324. Epub 2015 Sep 26.
Public notes

Contacts
Principal investigator
Name 0 0
Evan Hersh, MD
Address 0 0
University of Arizona
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications