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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00864253
Ethics application status
Date submitted
16/03/2009
Date registered
18/03/2009
Date last updated
30/10/2019

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
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

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.
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
Timepoint [1] 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
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)
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
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
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
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.
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
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

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
Sex
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
23/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/02/2014
Sample size
Target
Accrual to date
Final
529
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
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United States of America
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Alabama
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Arizona
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North Carolina
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Oklahoma
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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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Mainz
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BA
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FC
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Napoli
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Pisa
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Alkmaar
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Essex
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Glam
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Nott
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S Glam
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Staffs
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Wstmid
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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

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/study/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-naive 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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00864253