Trial · NCT00844649
Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
NCT00844649, Phase 3, Completed, Celgene; results first posted 2013-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas. Trials, record NCT00844649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00844649
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
- NCT number
- NCT00844649
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 861 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- Albumin-bound paclitaxel (ABI-007), Gemcitabine
- First posted
- 2009-02-16
- Last updated
- 2019-11-25
- Results first posted
- 2013-12-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months. | Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods. |
| Secondary | Progression-free Survival (PFS) by Independent Radiological Review (IRR) | Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months. | Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods. |
| Secondary | Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) | Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months | Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment. |
| Other | Participants With Treatment Emergent Adverse Events (AE) | Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days | A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. |
| Other | Number of Participants With Dose Reductions | Maximum time on treatment was 666 days | The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. |
| Other | Number of Participants With Dose Interruptions | Maximum time on treatment was 666 days | The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. |
| Other | Number of Participants With Dose Delays/Doses Not Given | Up to 666 days | The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months. | Intent to Treat population (ITT population) consisted of all randomized participants. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) by Independent Radiological Review (IRR) | Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months. | Intent to Treat population (ITT population) consisted of all randomized participants. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) | Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months | Intent to Treat population (ITT population) consisted of all randomized participants. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Participants With Treatment Emergent Adverse Events (AE) | Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days | Treated patient population | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Dose Reductions | Maximum time on treatment was 666 days | Treated Population | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Dose Interruptions | Maximum time on treatment was 666 days | Safety population, includes participants who received at least one study treatment | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Dose Delays/Doses Not Given | Up to 666 days | Treated Population | number of dose delays | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 8.5 | 95% Confidence Interval 7.89 to 9.53 | months | |
| Overall Survival (OS) | Gemcitabine | 6.7 | 95% Confidence Interval 6.01 to 7.23 | months | |
| Progression-free Survival (PFS) by Independent Radiological Review (IRR) | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 5.5 | 95% Confidence Interval 4.47 to 5.95 | months | |
| Progression-free Survival (PFS) by Independent Radiological Review (IRR) | Gemcitabine | 3.7 | 95% Confidence Interval 3.61 to 4.04 | months | |
| Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 23 | 95% Confidence Interval 19.1 to 27.2 | percentage of participants | |
| Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) | Gemcitabine | 7 | 95% Confidence Interval 5.0 to 10.1 | percentage of participants | |
| Participants With Treatment Emergent Adverse Events (AE) | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | At least 1 AE | 417 | participants | |
| Participants With Treatment Emergent Adverse Events (AE) | Gemcitabine | At least 1 AE | 395 | participants | |
| Participants With Treatment Emergent Adverse Events (AE) | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | ≥ 1 Treatment related AE (TEAE) | 403 | participants | |
| Participants With Treatment Emergent Adverse Events (AE) | Gemcitabine | ≥ 1 Treatment related AE (TEAE) | 371 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem) | 431 | |
| Overall Study | STARTED | Gemcitabine (Gem) | 430 | |
| Overall Study | Treated Population | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem) | 421 | |
| Overall Study | Treated Population | Gemcitabine (Gem) | 402 | |
| Overall Study | COMPLETED | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem) | 26 | |
| Overall Study | COMPLETED | Gemcitabine (Gem) | 12 | |
| Overall Study | NOT COMPLETED | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem) | 405 | |
| Overall Study | NOT COMPLETED | Gemcitabine (Gem) | 418 |
Source ClinicalTrials.gov
Adverse events584
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 | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 247 | 421 | |
| other | Fatigue | General disorders | Gemcitabine | 183 | 402 | |
| other | Oedema peripheral | General disorders | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 194 | 421 | |
| other | Oedema peripheral | General disorders | Gemcitabine | 123 | 402 | |
| other | Pyrexia | General disorders | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 160 | 421 | |
| other | Pyrexia | General disorders | Gemcitabine | 111 | 402 | |
| other | Asthenia | General disorders | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 77 | 421 | |
| other | Asthenia | General disorders | Gemcitabine | 51 | 402 | |
| other | Chills | General disorders | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 48 | 421 | |
| other | Chills | General disorders | Gemcitabine | 34 | 402 |
1 to 10 of 584Source ClinicalTrials.gov
See all 584 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | ||
| Total, all-cause mortality | Gemcitabine | ||
| Total, other adverse events | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 412 | 421 |
| Total, other adverse events | Gemcitabine | 392 | 402 |
| Total, serious adverse events | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 212 | 421 |
| Total, serious adverse events | Gemcitabine | 172 | 402 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine vs Gemcitabine: 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.
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/NCT00844649
GET https://conductscience.org/api/trials/v1/NCT00844649/results?page=2