Trial · NCT00864253

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

NCT00864253, Phase 3, Completed, Celgene; results first posted 2014-06-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma. Trials, record NCT00864253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00864253

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
NCT number: NCT00864253
Status: Completed
Phases: Phase 3
Enrollment: 529 participants, actual
Lead sponsor: Celgene
Conditions: Malignant Melanoma
Interventions: ABI-007, Dacarbazine
First posted: 2009-03-18
Last updated: 2019-10-30
Results first posted: 2014-06-05
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

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines	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 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.
Secondary	Participant Survival	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.
Secondary	Summary of Treatment-emergent Adverse Events (AEs)	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 medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Secondary	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	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.
Secondary	Nadir for the Absolute Neutrophil Count (ANC) Measurements	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.
Secondary	Nadir for White Blood Cells (WBCs) Measurements	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.
Secondary	Nadir for Platelet Count Measurements.	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.
Secondary	Nadir for the Hemoglobin Count Measurements	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.
Secondary	Pharmacokinetic Parameters	On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose
Other	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	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 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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines	Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012	Intent to treat population = The ITT population consisted of all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments collected.	months	MEDIAN
SECONDARY	Participant Survival	Up to 38 months; Up to data cut off of 30 June 2012	Intent to treat population	months	MEDIAN
OTHER_PRE_SPECIFIED	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	ITT	months	MEDIAN
OTHER_PRE_SPECIFIED	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	ITT	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	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	ITT	percent of participants	NUMBER
OTHER_PRE_SPECIFIED	Duration of Response (DOR) in Responding Participants	up to data cut off 30 June 2012	ITT of participants with a confirmed complete or partial overall response	months	MEDIAN
SECONDARY	Summary of Treatment-emergent Adverse Events (AEs)	Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012	Treated Population = The Treated population consisted of all randomized participants who received at least one dose of study drug	participants	NUMBER
SECONDARY	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	Treated population	participants	NUMBER
SECONDARY	Nadir for the Absolute Neutrophil Count (ANC) Measurements	Day 1 up to 106 weeks; up to data cut off 30 June 2012	Treated Population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included	10^9/L	MEDIAN
SECONDARY	Nadir for White Blood Cells (WBCs) Measurements	Day 1 up to 106 weeks; up to data cut off 30 June 2012	Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included	10^9/L	MEDIAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines	ABI-007 150mg/m^2		4.8	95% Confidence Interval 3.7 to 5.5	months
Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines	Dacarbazine 1000mg/m^2		2.5	95% Confidence Interval 2.0 to 3.6	months
Participant Survival	ABI-007 150mg/m^2		12.8	95% Confidence Interval 11.3 to 14.6	months
Participant Survival	Dacarbazine 1000mg/m^2		10.7	95% Confidence Interval 9.6 to 12.5	months
Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines	ABI-007 150mg/m^2		3.7	95% Confidence Interval 3.1 to 3.9	months
Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines	Dacarbazine 1000mg/m^2		2.1	95% Confidence Interval 1.9 to 2.5	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	ABI-007 150mg/m^2	Complete Response (CR)	0		percentage of participants
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	Dacarbazine 1000mg/m^2	Complete Response (CR)	0		percentage of participants
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	ABI-007 150mg/m^2	Partial Response (PR)	15		percentage of participants
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	Dacarbazine 1000mg/m^2	Partial Response (PR)	11		percentage of participants

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ABI-007 150mg/m^2	264
Overall Study	STARTED	Dacarbazine 1000mg/m^2	265
Overall Study	Treated	ABI-007 150mg/m^2	257
Overall Study	Treated	Dacarbazine 1000mg/m^2	258
Overall Study	COMPLETED	ABI-007 150mg/m^2	165
Overall Study	COMPLETED	Dacarbazine 1000mg/m^2	207
Overall Study	NOT COMPLETED	ABI-007 150mg/m^2	99
Overall Study	NOT COMPLETED	Dacarbazine 1000mg/m^2	58

Source ClinicalTrials.gov

Adverse events310

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Alopecia	Skin and subcutaneous tissue disorders	ABI-007 Arm A	177	257
other	Alopecia	Skin and subcutaneous tissue disorders	Dacarbazine Arm B	9	258
other	Rash	Skin and subcutaneous tissue disorders	ABI-007 Arm A	72	257
other	Rash	Skin and subcutaneous tissue disorders	Dacarbazine Arm B	18	258
other	Nail disorder	Skin and subcutaneous tissue disorders	ABI-007 Arm A	52	257
other	Nail disorder	Skin and subcutaneous tissue disorders	Dacarbazine Arm B	2	258
other	Pruritus	Skin and subcutaneous tissue disorders	ABI-007 Arm A	31	257
other	Pruritus	Skin and subcutaneous tissue disorders	Dacarbazine Arm B	17	258
other	Dry skin	Skin and subcutaneous tissue disorders	ABI-007 Arm A	24	257
other	Dry skin	Skin and subcutaneous tissue disorders	Dacarbazine Arm B	5	258

1 to 10 of 310Source ClinicalTrials.gov

See all 310 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ABI-007 Arm A
Total, all-cause mortality	Dacarbazine Arm B
Total, other adverse events	ABI-007 Arm A	253	257
Total, other adverse events	Dacarbazine Arm B	232	258
Total, serious adverse events	ABI-007 Arm A	62	257
Total, serious adverse events	Dacarbazine Arm B	54	258

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26410620	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
ABI-007 Arm A vs Dacarbazine Arm B: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00864253

GET https://conductscience.org/api/trials/v1/NCT00864253/results?page=2

API reference For AI assistants