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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00864253
First received: March 16, 2009
Last updated: August 6, 2013
Last verified: May 2013

March 16, 2009
August 6, 2013
April 2009
June 2012   (final data collection date for primary outcome measure)
The primary efficacy endpoint is progression-free survival (PFS) based on a blinded radiology assessment of response using RECIST response guidelines. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00864253 on ClinicalTrials.gov Archive Site
  • The secondary efficacy endpoint is patient survival. [ Time Frame: varies ] [ Designated as safety issue: No ]
  • Progression-free survival based on investigator assessment. [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Number (%) of patients who achieve an objective confirmed complete or partial response [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Number (%) of patients with stable disease for ≥ 16 weeks, or confirmed complete or partial response (i.e., total response) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Duration of response in responding patients. [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Correlation of SPARC and other molecular biomarkers with efficacy outcomes. [ Time Frame: varies ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent and treatment related adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • Laboratory abnormalities. [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • Nadir of myelosuppression during study drug dosing. [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • Incidence of patients experiencing dose modifications, dose interruptions, and/or premature discontinuation of study drug. [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • The pharmacokinetic parameters are the maximum plasma drug concentration (Cmax), the area under the plasma concentration versus time curve (AUC and AUCinf), the half-life of the apparent terminal portion of the concentration versus time curve (T1/2). [ Time Frame: cycle 1 day 1: ABI-007 arm only ] [ Designated as safety issue: No ]
  • The pharmacokinetic parameters also include the total body clearance (CL), and the volume of distribution (Vz). [ Time Frame: cycle 1 day 1: ABI-007 arm only ] [ Designated as safety issue: No ]
  • The secondary efficacy endpoint is patient survival. [ Time Frame: varies ] [ Designated as safety issue: No ]
  • Progression-free survival based on investigator assessment. [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Number (%) of patients who achieve an objective confirmed complete or partial response [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Number (%) of patients with stable disease for ≥ 16 weeks, or confirmed complete or partial response (i.e., total response) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Duration of response in responding patients. [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Correlation of SPARC and other molecular biomarkers with efficacy outcomes. [ Time Frame: varies ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent and treatment related adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • Laboratory abnormalities. [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • Nadir of myelosuppression during study drug dosing. [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • Incidence of patients experiencing dose modifications, dose interruptions, and/or premature discontinuation of study drug. [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • The pharmacokinetic parameters are the maximum plasma drug concentration (Cmax), the area under the plasma concentration versus time curve (AUC and AUCinf), the half-life of the apparent terminal portion of the concentration versus time curve (T1/2), the [ Time Frame: cycle 1 day 1: ABI-007 arm only ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Drug: 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.
    Other Name: Abraxane
  • Drug: 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.
    Other Name: Dtic-Dome, DTIC-Dome
  • 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.
    Intervention: Drug: ABI-007
  • 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.
    Intervention: Drug: Dacarbazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
529
March 2014
June 2012   (final data collection date for primary outcome measure)

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, 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 (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 [see Section 8.3.1.1 for definition of measurable lesions]).
  • 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.
  • 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
  • Expected survival of > 12 weeks.
  • 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 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT00864253
CA033
Yes
Celgene Corporation
Celgene Corporation
University of Arizona
Principal Investigator: Evan Hersh, MD University of Arizona
Study Director: Ileana Elias, MD Celgene Corporation
Celgene Corporation
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP