TriangleNCT00844649 · STUDY IN CONTEXT
Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- trial label
- Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0003
- source section id
- NCT00844649-om-0003
- source outcome index
- 3
- endpoint
- Participants With Treatment Emergent Adverse Events (AE)
- endpoint definition
- 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.
- time origin
- Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treated patient population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0004
- source section id
- NCT00844649-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Dose Reductions
- endpoint definition
- 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.
- time origin
- Maximum time on treatment was 666 days
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treated Population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0005
- source section id
- NCT00844649-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Dose Interruptions
- endpoint definition
- 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.
- time origin
- Maximum time on treatment was 666 days
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety population, includes participants who received at least one study treatment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0000
- source section id
- NCT00844649-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- 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.
- time origin
- From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat population (ITT population) consisted of all randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0001
- source section id
- NCT00844649-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS) by Independent Radiological Review (IRR)
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat population (ITT population) consisted of all randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0002
- source section id
- NCT00844649-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
- endpoint definition
- 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.
- time origin
- Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat population (ITT population) consisted of all randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
- regimen
- Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
- analyzed count
- 431
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Gemcitabine
- regimen
- Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
- analyzed count
- 430
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
- regimen
- Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
- analyzed count
- 431
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Gemcitabine
- regimen
- Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
- analyzed count
- 430
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
- regimen
- Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
- analyzed count
- 431
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Gemcitabine
- regimen
- Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
- analyzed count
- 430
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
- regimen
- Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
- analyzed count
- 421
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Gemcitabine
- regimen
- Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
- analyzed count
- 402
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)
- regimen
- Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
- analyzed count
- 421
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Gemcitabine (Gem)
- regimen
- Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
- analyzed count
- 402
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
- regimen
- Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
- analyzed count
- 421
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Gemcitabine
- regimen
- Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
- analyzed count
- 402
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00844649-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- harm key
- EG000
- source section id
- NCT00844649-ae
- event group key
- EG000
- event group label
- Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
- serious affected
- 212
- serious at risk
- 421
- other affected
- 412
- other at risk
- 421
- frequency threshold
- 5
- collection period
- Day 1 up to 30 days after the last dose (a maximum of 666 days)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT00844649
- harm key
- EG001
- source section id
- NCT00844649-ae
- event group key
- EG001
- event group label
- Gemcitabine
- serious affected
- 172
- serious at risk
- 402
- other affected
- 392
- other at risk
- 402
- frequency threshold
- 5
- collection period
- Day 1 up to 30 days after the last dose (a maximum of 666 days)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice