A clinical trial to compare the safety and effectiveness of Abraxane versus dacarbazine, in the treatment of advanced stage melanoma that has spread to other parts of the body (metastatic malignant melanoma).

• Register: EUCTR
• Last refreshed on: 16 February 2015
• Main ID: EUCTR2007-004097-32-DE
• Date of registration: 15/05/2009
• Prospective Registration: Yes
• Primary sponsor: Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation
• Public title: A clinical trial to compare the safety and effectiveness of Abraxane versus dacarbazine, in the treatment of advanced stage melanoma that has spread to other parts of the body (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
• Date of first enrolment: 06/01/2010
• Target sample size: 514
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004097-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: Heidi B. Marks
• Affiliation: Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation

• Name: Heidi B. Marks
• Affiliation: Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histologically or cytologically confirmed malignant melanoma with evidence of metastasis (Stage IV).
2. No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. No prior adjuvant cytotoxic chemotherapy is permitted. Prior treatment with kinase inhibitors or cytokines is permitted. Prior adjuvant therapy with interferon, GM-CSF and/or vaccines is permitted. Prior treatments should be completed 4 weeks prior to enrollment in the study.
3. 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 (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 during the period of administration of dacarbazine or ABI-007. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product’s Summary of Product Characteristics or Prescribing Information provided in the study manual.
4. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone and have been continuously disease-free for at least 5 years.
5. Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion).
6. Patient has the following blood counts at Baseline:
- ANC = 1.5 x 109 cells/L;
- platelets = 100 x 109 cells/L;
- Hgb = 9 g/dL.
7. Patient has the following blood chemistry levels at Baseline:
- AST (SGOT), ALT (SGPT) = 2.5x upper limit of normal range (ULN); = 5.0 xULN if hepatic metastases present;
- total bilirubin = ULN;
- creatinine = 1.5 mg/dL.
- LDH = 2.0 x ULNa
8. Expected survival of > 12 weeks.
9. ECOG performance status 0-1.
10. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 283
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 231

Exclusion criteria:
1. History of or current evidence of brain metastases, including leptomeningeal involvement.
2. Patient has pre-existing peripheral neuropathy of NCI CTCAE Scale of Grade = 2.
3. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
4. Patient has a clinically significant concurrent illness.
5. Patient is, in the investigator’s opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
6. 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.
7. 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.
8. Any known severe hypersensitivity reaction to any substances included in the investigational product or comparator.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Metastatic Malignant Melanoma
MedDRA version: 16.1 Level: PT Classification code 10025671 Term: Malignant melanoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.1 Level: PT Classification code 10027480 Term: Metastatic malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Trade Name: Abraxane
Product Name: ABI-007
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: PACLITAXEL
CAS Number: 33069624
Current Sponsor code: ABI-007
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Dacarbazine
Product Name: Dacarbazine
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: DACARBAZINE
CAS Number: 4342034
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Product Name: Dacarbazine
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: DACARBAZINE
CAS Number: 4342034

Primary Outcome(s)

Secondary Objective: • Compare the safety and tolerability of the 2 treatments;
• Evaluate pharmacokinetic parameters of ABI-007; and
• Compare SPARC and other molecular biomarkers with efficacy outcomes.

Primary end point(s): The primary efficacy endpoint is progression-free survival (PFS) based on a blinded radiology assessment of response using RECIST response guidelines.

Timepoint(s) of evaluation of this end point: The final analysis of independently-assessed PFS will be conducted based on all data through 30 June 2012.

Main Objective: The primary objective of this study is to compare the following regimens with respect to antitumor activity in patients who are previously untreated with cytotoxic chemotherapy for metastatic malignant melanoma:
• ABI-007 150 mg/m2 Days 1, 8, and 15 every 4 weeks
• Dacarbazine 1000 mg/m2 every 3 weeks

Secondary Outcome(s)

Secondary end point(s): Patient survival.

Timepoint(s) of evaluation of this end point: Final analysis of overall survival after 417 events

Secondary ID(s)

CA033

2007-004097-32-GB

Source(s) of Monetary Support

Abraxis BioScience LLC, a wholly owned subsidiary of Celgene Corporation