A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
1 other identifier
interventional
529
9 countries
112
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2009
Longer than P75 for phase_3
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedStudy Start
First participant enrolled
April 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2014
CompletedResults Posted
Study results publicly available
June 5, 2014
CompletedOctober 30, 2019
October 1, 2019
3.1 years
March 16, 2009
April 16, 2014
October 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012
Secondary Outcomes (8)
Participant Survival
Up to 38 months; Up to data cut off of 30 June 2012
Summary of Treatment-emergent Adverse Events (AEs)
Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012
Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug
Maximum study drug exposure 106 weeks; data cut off 30 June 2012
Nadir for the Absolute Neutrophil Count (ANC) Measurements
Day 1 up to 106 weeks; up to data cut off 30 June 2012
Nadir for White Blood Cells (WBCs) Measurements
Day 1 up to 106 weeks; up to data cut off 30 June 2012
- +3 more secondary outcomes
Other Outcomes (4)
Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines
Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months
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
every 8 weeks; up to data cut off 30 June 2012
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
Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012
- +1 more other outcomes
Study Arms (2)
ABI-007
EXPERIMENTALTreatment 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.
Dacarbazine
ACTIVE COMPARATORTreatment 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
- University of Arizonacollaborator
Study Sites (112)
University of Alabama at Birmingham
Birmingham, Alabama, 35243, United States
AZ Cancer Ctr
Scottsdale, Arizona, 85258, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Genesis Cancer Ctr - Hot Springs
Hot Springs, Arkansas, 71913, United States
University of Arkansa for Medical Sciences
Little Rock, Arkansas, 72205, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
San Diego Pacific Oncology and Hematology Associates
Encinitas, California, 92024, United States
Loma Linda University Cancer Center
Loma Linda, California, 92354, United States
University of Southern California/Norris Cancer Center
Los Angeles, California, 90033, United States
University of CA Los Angeles
Los Angeles, California, 90095, United States
St. Mary's Medical Center
San Francisco, California, 94117, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
University of Miami Hospital and Clincs/SCCC
Miami, Florida, 33136, United States
Waren Billhartz Cancer Center
Maryville, Illinois, 62062, United States
Indiana University
Indianapolis, Indiana, 46202, United States
IA Blood and Cancer Care, PLC
Cedar Rapids, Iowa, 52402, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Wayne State University
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
St. John's Medical Research
Springfield, Missouri, 65807, United States
Saint Louis University
St Louis, Missouri, 63110, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Atlantic Melanoma Center
Morristown, New Jersey, 07962, United States
Piedmont Hematology
Winston-Salem, North Carolina, 27103, United States
OH State University Arthur G. James Cancer Hospital
Columbus, Ohio, 43210, United States
Integris Cancer Institute of OK
Oklahoma City, Oklahoma, 73142, United States
St. Luke's Hospital & Health Network
Bethlehem, Pennsylvania, 18015, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19131, United States
Mary Crowley Research Center
Dallas, Texas, 75246, United States
Univ of TX MD Anderson Cancer Ctr
Houston, Texas, 77030, United States
Univ of TX Med School at Houston
Houston, Texas, 77030, United States
Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Hope Oncology
Richardson, Texas, 75080, United States
Utah Cancer Specialist
Salt Lake City, Utah, 84106, United States
Univ. of Washington Medical Center/Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Evergreen Hematology & Oncology
Spokane, Washington, 99218, United States
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
Sydney West Cancer Trials Centre/Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Adelaide Hospital, Department of Medical Oncology
Adelaide, South Australia, 5000, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Sir Charles Gairdner Hospital
Nedlands Perth, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BCCA Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
BCCA, Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
BC Cancer Agency-Fraser Valley Ctr.
Surrey, British Columbia, V3V 1Z2, Canada
BC Cancer Agency-Vancouver
Vancouver, British Columbia, V5Z4E6, Canada
BC Cancer Agency-Vancouver Island Ctr.
Victoria, British Columbia, V8R 6V5, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Credit Valley Hospital
Missiauga, Ontario, L5M 2N1, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
McGill University Dept. of Oncology Clinical Research Program
Montreal, Quebec, H2W 1S6, Canada
Hopital Saint Andre' CHU de Bordeaux
Bordeaux, 33075, France
Centre Hospitaller Universitaire de Grenoble
Grenoble, 38043, France
CHRU Hopital Claude Huriez
Lile Cedax, France
Hopital Dypuytren-CHU de Limoges
Limoges, France
Centre Leon Berad
Lyon, France
Hopital Sainte Marguerite
Marseille, France
CHU Hopital Saint Eloi
Montepellier Cedex 5, France
Centre Regional Val d' Aurelle Paul Lamarque
Montpellier, 34298, France
Hopital de 1 Archet 2
Nice, 06200, France
Hopital Bichat
Paris, 75018, France
Groupe hospitalier Cochin-St. Vincent de Paul
Paris, France
Hopital Saint-Louis
Paris, France
Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc
Villejuif, 94805, France
Universitaetsklinkum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinkum Heidelberg
Heidelber, Baden-Wurttemberg, Germany
Universitaetsklinkum Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinkum Wuerzburg PS
Würzburg, Bavaria, 97080, Germany
Universitaetsklinkum Hamburg-Eppendorf
Hamburg, Hamburg, Germany
Univeritaetsklinkum Goettingen
Gottington, Lower Saxony, Germany
Medizinische Hochschuke Hannover
Hanover, Lower Saxony, 30625, Germany
St. Josef-Hospital
Bochum, Northwest, 44791, Germany
Universitaetklinkum Koeln
Cologne, Northwest, Germany
Universitaetsklinkum Essen
Essen, Northwest, Germany
Universitaetsklinkum Dresden
Dresden, Saxony, Germany
Universitaetsklinkum Schegwig-Holstein
Keil, Schleswig-Holstein, 24105, Germany
Charite Universitaetsmedizin Berlin
Berlin, State of Berlin, 10117, Germany
UniversitawtsklinKum Jena
Jena, Strasse 35, 07743, Germany
Universitaesklinkum Leipzig
Leipzig, Germany
Universitaetsklinkum Mainz
Mainz, Germany
Istituto Tumori "Giovanni Paolo II"
Bari, BA, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei T
Meldola, FC, 47014, Italy
IST-Istituto Nazionale per la Ricera sul Cancro
Genova, GE, 16132, Italy
Istituto Europeo di Oncologia
Milan, MI, 20141, Italy
Istituto Nazionale Tumori
Milan, MI, Italy
IOV-Instituto Oncologico IRCCS
Padua, PD, 35128, Italy
Azienda Ospedaliera Universitaria Sense
Siena, SI, 53100, Italy
Ist. Naz. per lo studio e la cura dei tumori G. Pascale
Napoli, 80131, Italy
Ospedale S. Chiara
Pisa, 56100, Italy
Medisch Centrum Alkmaar
Alkmaar, 1815, Netherlands
Rijnstate ziekenhuis Arnhem
Amhem, 6800TA, Netherlands
Erasmus MC ae" Daniel den Hoed
Rotterdam, Netherlands
H Clinic i Provincial
Barcelona, 08036, Spain
H CLINIC I Provincial
Barcelona, Spain
H Clinico San Carlos
Madrid, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, 08208, Spain
Broomfield Hospital
Chelmsford, Essex, CM1 7ET, United Kingdom
Velindre Hospital
Cardiff, GLAM, CF14 2TL, United Kingdom
St. George's Hospital
London, GT Lon, SW12 ORE, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NOTT, NG5 1PB, United Kingdom
Singleton Hospital, Sothwest Wales Inst.
Swansea, S GLAM, SA28QA, United Kingdom
Univ Hospital of North Staffordshire
Stroke on Kent, Staffs, ST4 6QB, United Kingdom
Weston Park Hospital
Sheffield, Syorks, S10 2SJ, United Kingdom
Newcross Hospital
Wolverhampton, Wstmid, SV10 0QP, United Kingdom
Royal Marsden Hospital London
London, SW3 6JJ, United Kingdom
Related Publications (1)
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.
PMID: 26410620BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Participation in the PK sampling for participants randomized to the ABI-007 arm was optional; too few samples were available to support the analysis
Results Point of Contact
- Title
- Anne McClain
- Organization
- Celgene Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Hersh, MD
University of Arizona
- STUDY DIRECTOR
Ileana Elias, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 18, 2009
Study Start
April 23, 2009
Primary Completion
June 1, 2012
Study Completion
February 12, 2014
Last Updated
October 30, 2019
Results First Posted
June 5, 2014
Record last verified: 2019-10