18 and older, any sex, with Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) GuidelinesPrimary· Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012
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 whe
Group
Value
95% CI
ABI-007 150mg/m^2
4.8
3.7 – 5.5
Dacarbazine 1000mg/m^2
2.5
2.0 – 3.6
Participant SurvivalSecondary· Up to 38 months; Up to data cut off of 30 June 2012
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.
Group
Value
95% CI
ABI-007 150mg/m^2
12.8
11.3 – 14.6
Dacarbazine 1000mg/m^2
10.7
9.6 – 12.5
Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response GuidelinesSecondary· Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months
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, patients who began new anticancer therapy prior to documented progression were censored at the last assessment where t
Group
Value
95% CI
ABI-007 150mg/m^2
3.7
3.1 – 3.9
Dacarbazine 1000mg/m^2
2.1
1.9 – 2.5
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 1.0Secondary· every 8 weeks; up to data cut off 30 June 2012
RECIST defines complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks
Complete Response (CR)
Group
Value
95% CI
ABI-007 150mg/m^2
0
Dacarbazine 1000mg/m^2
0
Partial Response (PR)
Group
Value
95% CI
ABI-007 150mg/m^2
15
Dacarbazine 1000mg/m^2
11
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 ResponseSecondary· Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012
Disease control is stable disease (SD) for \>=16 weeks + complete response (CR) + partial response (PR). See Outcome #4 for definitions of CR and PR.
RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
Group
Value
95% CI
ABI-007 150mg/m^2
39
Dacarbazine 1000mg/m^2
27
Duration of Response (DOR) in Responding ParticipantsSecondary· up to data cut off 30 June 2012
Duration of response (DOR) as measured by PFS based on radiological review for participants who achieved an objective confirmed response of CR or PR. DOR was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or participants death from any cause, whichever occurred first. Participants that did not have progression or had not died were censored at the last known time the participant was progression free. Participants that had initiated other anticancer therapy prior
Group
Value
95% CI
ABI-007 150mg/m^2
11.1
7.3 – NA
Dacarbazine 1000mg/m^2
16.4
11.0 – 21.8
Summary of Treatment-emergent Adverse Events (AEs)Secondary· Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012
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 medic
≥1 TEAE
Group
Value
95% CI
ABI-007 150mg/m^2
255
Dacarbazine 1000mg/m^2
239
≥1 TEAE related to study drug
Group
Value
95% CI
ABI-007 150mg/m^2
250
Dacarbazine 1000mg/m^2
212
≥1 NCI CTCAE Grade (GR) 3 or above
Group
Value
95% CI
ABI-007 150mg/m^2
167
Dacarbazine 1000mg/m^2
117
≥1 NCI CTCAE GR 3 or above TEAE to study drug
Group
Value
95% CI
ABI-007 150mg/m^2
129
Dacarbazine 1000mg/m^2
71
≥1 TEAE with outcome of death
Group
Value
95% CI
ABI-007 150mg/m^2
8
Dacarbazine 1000mg/m^2
1
≥1 drug related TEAE with outcome of death
Group
Value
95% CI
ABI-007 150mg/m^2
2
Dacarbazine 1000mg/m^2
1
≥1 serious TEAE
Group
Value
95% CI
ABI-007 150mg/m^2
62
Dacarbazine 1000mg/m^2
54
≥1 serious TEAE related to study drug
Group
Value
95% CI
ABI-007 150mg/m^2
23
Dacarbazine 1000mg/m^2
17
Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study DrugSecondary· Maximum study drug exposure 106 weeks; data cut off 30 June 2012
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.
Dose Reductions
Group
Value
95% CI
ABI-007 150mg/m^2
81
Dacarbazine 1000mg/m^2
51
Dose Interruptions
Group
Value
95% CI
ABI-007 150mg/m^2
6
Dacarbazine 1000mg/m^2
17
Dose Delay
Group
Value
95% CI
ABI-007 150mg/m^2
145
Dacarbazine 1000mg/m^2
105
Nadir for the Absolute Neutrophil Count (ANC) MeasurementsSecondary· Day 1 up to 106 weeks; up to data cut off 30 June 2012
Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.
Group
Value
95% CI
ABI-007 150mg/m^2
1.50
0.1 – 20.0
Dacarbazine 1000mg/m^2
2.40
0.0 – 13.2
Nadir for White Blood Cells (WBCs) MeasurementsSecondary· Day 1 up to 106 weeks; up to data cut off 30 June 2012
Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.
Group
Value
95% CI
ABI-007 150mg/m^2
3.00
0.6 – 22.8
Dacarbazine 1000mg/m^2
4.10
0.5 – 14.7
Nadir for Platelet Count Measurements.Secondary· Day 1 up to 106 weeks; up to data cut off 30 June 2012
Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.
Group
Value
95% CI
ABI-007 150mg/m^2
228.5
112 – 437
Dacarbazine Arm B
153
9 – 723
Nadir for the Hemoglobin Count MeasurementsSecondary· Day 1 up to 106 weeks; up to data cut off 30 June 2012
Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.
Group
Value
95% CI
ABI-007 150mg/m^2
109.0
65.0 – 137
Dacarbazine 1000mg/m^2
122.0
65 – 161
Adverse events — posted to ClinicalTrials.gov
Time frame: Any adverse event (AE) that started at any time from the time the signing of the informed consent to 30 days after the last dose of study drug or End of Study was followed and reported; maximum drug exposure 106 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
ABI-007 Arm A
Serious: 62/257 (24%)
Deaths: —
Dacarbazine Arm B
Serious: 54/258 (21%)
Deaths: —
Serious adverse events (102 terms)
Reaction
System
ABI-007 Arm A
Dacarbazine Arm B
Pyrexia
General disorders
—
—
Pneumonia
Infections and infestations
—
—
Cellulitis
Infections and infestations
—
—
Erysipelas
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Peripheral motor neuropathy
Nervous system disorders
—
—
Peripheral sensory neuropathy
Nervous system disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Angina pectoris
Cardiac disorders
—
—
Atrial fibrillation
Cardiac disorders
—
—
Acute myocardial infarction
Cardiac disorders
—
—
Haemoptysis
Respiratory, thoracic and mediastinal disorders
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02103062 — Phase 2 Study With Abraxane (Nab®Paclitaxel) in Metastatic Colorectal Cancer
· Phase 2
· completed
NCT02021500 — A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.
· completed
NCT01827111 — Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma
· Phase 2
· completed
NCT01478685 — A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or
· Phase 1
· completed
NCT00456846 — First Line Therapy for Patients With Metastatic Breast Cancer
· Phase 2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 30 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00864253.