TriangleNCT01494506 · STUDY IN CONTEXT
Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
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
Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
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. 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. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
The objective response rate was a secondary efficacy endpoint of the study and was defined by the percentage of patients in the study population with a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator. Best overall response was defined per RECIST (version 1.1) recorded from randomization until progression or end of study. RECIST (v 1.1) criteria does not require confirmation of response, but an additional, more stringent analysis was also conducted, with designation of CR (or PR) requiring confirmation of response at least 4 weeks following the initial assessment of CR (or PR). Stable disease (SD) required an assessment of SD at least 6 weeks after starting treatment. Subjects with insufficient data for response classification were classified as Not Evaluable for best overall response, and as a non-responder for objective response, in the ITT population. Treatment groups are as indicated for the primary outcome of OS.
Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either: (a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain. With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change. Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.
Reported safety
Quality of life and patient-reported measures
Patient-reported symptom or function measure · Percentage of Patients With Clinical Benefit Response
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- qol key
- qol-0004
- source section id
- NCT01494506-om-0004
- source outcome index
- 4
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Percentage of Patients With Clinical Benefit Response
- measure definition
- Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either: (a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain. With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change. Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
- time frame
- Randomization to treatment discontinuation.The maximum time in follow up was 25 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR: * baseline pain intensity ≥ 20 (out of 100) * baseline morphine consumption ≥ 10 mg/day PO morphine equivalents * baseline KPS of 70 to 90 points
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC-QLQ-C30
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- qol key
- qol-0006
- source section id
- NCT01494506-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC-QLQ-C30
- measure definition
- This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.
- time frame
- Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- trial label
- Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
- 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
- 3
- qol Count
- 2
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0000
- source section id
- NCT01494506-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
- time origin
- From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat population (ITT population) consisted of all randomized participants. Efficacy analyses in the ITT population consider treatment group according to randomization. Comparisons of the MM-398+5-FU/LV to 5-FU/LV were carried out only on patients who were randomized under protocol version 2 or later.
- 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-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0001
- source section id
- NCT01494506-om-0001
- source outcome index
- 1
- endpoint
- Progression Free Survival
- 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. 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. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
- time origin
- Randomization until disease progression or death from any cause; Until the data cut off of 14 Feb 2014. The maximum time in follow up was 25 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT 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-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0002
- source section id
- NCT01494506-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate
- endpoint definition
- The objective response rate was a secondary efficacy endpoint of the study and was defined by the percentage of patients in the study population with a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator. Best overall response was defined per RECIST (version 1.1) recorded from randomization until progression or end of study. RECIST (v 1.1) criteria does not require confirmation of response, but an additional, more stringent analysis was also conducted, with designation of CR (or PR) requiring confirmation of response at least 4 weeks following the initial assessment of CR (or PR). Stable disease (SD) required an assessment of SD at least 6 weeks after starting treatment. Subjects with insufficient data for response classification were classified as Not Evaluable for best overall response, and as a non-responder for objective response, in the ITT population. Treatment groups are as indicated for the primary outcome of OS.
- time origin
- Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT 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-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0003
- source section id
- NCT01494506-om-0003
- source outcome index
- 3
- endpoint
- Time to Treatment Failure
- endpoint definition
- Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
- time origin
- Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT 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-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0004
- source section id
- NCT01494506-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Patients With Clinical Benefit Response
- endpoint definition
- Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either: (a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain. With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change. Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
- time origin
- Randomization to treatment discontinuation.The maximum time in follow up was 25 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR: * baseline pain intensity ≥ 20 (out of 100) * baseline morphine consumption ≥ 10 mg/day PO morphine equivalents * baseline KPS of 70 to 90 points
- 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-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0005
- source section id
- NCT01494506-om-0005
- source outcome index
- 5
- endpoint
- Percentage of Patients With Tumor Marker (CA 19-9) Response
- endpoint definition
- Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.
- time origin
- Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients with elevated baseline CA19-9 value (\> 30 U/mL) who received study drug.
- 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-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0000
- arm key
- OG000
- arm label
- MM-398 Arm A (Mono Therapy Comparison)
- regimen
- • MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
- analyzed count
- 151
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0000
- arm key
- OG001
- arm label
- 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
- regimen
- * 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
- analyzed count
- 149
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0000
- arm key
- OG002
- arm label
- MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
- regimen
- * MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2. * 5-FU 2400 mg/m2 IV over 46-hours, and * Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks
- analyzed count
- 117
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0000
- arm key
- OG003
- arm label
- 5-FU + Leucovorin (Combo Therapy Comparison)
- regimen
- * 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
- analyzed count
- 119
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0001
- arm key
- OG000
- arm label
- MM-398 Arm A (Mono Therapy Comparison)
- regimen
- • MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
- analyzed count
- 151
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0001
- arm key
- OG001
- arm label
- 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
- regimen
- * 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
- analyzed count
- 149
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0001
- arm key
- OG002
- arm label
- MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
- regimen
- * MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2. * 5-FU 2400 mg/m2 IV over 46-hours, and * Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks
- analyzed count
- 117
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0001
- arm key
- OG003
- arm label
- 5-FU + Leucovorin (Combo Therapy Comparison)
- regimen
- * 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
- analyzed count
- 119
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0002
- arm key
- OG000
- arm label
- MM-398 Arm A (Mono Therapy Comparison)
- regimen
- • MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
- analyzed count
- 151
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0002
- arm key
- OG001
- arm label
- 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
- regimen
- * 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
- analyzed count
- 149
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0002
- arm key
- OG002
- arm label
- MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
- regimen
- * MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2. * 5-FU 2400 mg/m2 IV over 46-hours, and * Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks
- analyzed count
- 117
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- outcome key
- om-0002
- arm key
- OG003
- arm label
- 5-FU + Leucovorin (Combo Therapy Comparison)
- regimen
- * 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
- analyzed count
- 119
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01494506-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- harm key
- EG000
- source section id
- NCT01494506-ae
- event group key
- EG000
- event group label
- MM-398
- serious affected
- 90
- serious at risk
- 147
- other affected
- 145
- other at risk
- 147
- frequency threshold
- 5
- collection period
- Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 764 days.
- event definition
- 5-FU= 5-fluorouracil; LV=leucovorin Events were collected by systematic assessment Term from vocabulary, MedDRA version 14.1
- 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-avgemsi-9fcc56af
- nct id
- NCT01494506
- harm key
- EG001
- source section id
- NCT01494506-ae
- event group key
- EG001
- event group label
- 5 Fluorouracil and Leucovorin IV
- serious affected
- 58
- serious at risk
- 134
- other affected
- 132
- other at risk
- 134
- frequency threshold
- 5
- collection period
- Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 764 days.
- event definition
- 5-FU= 5-fluorouracil; LV=leucovorin Events were collected by systematic assessment Term from vocabulary, MedDRA version 14.1
- 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-avgemsi-9fcc56af
- nct id
- NCT01494506
- harm key
- EG002
- source section id
- NCT01494506-ae
- event group key
- EG002
- event group label
- MM-398, 5-FU and Leucovorin
- serious affected
- 56
- serious at risk
- 117
- other affected
- 116
- other at risk
- 117
- frequency threshold
- 5
- collection period
- Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 764 days.
- event definition
- 5-FU= 5-fluorouracil; LV=leucovorin Events were collected by systematic assessment Term from vocabulary, MedDRA version 14.1
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-avgemsi-9fcc56af
- nct id
- NCT01494506
- qol key
- qol-0004
- source section id
- NCT01494506-om-0004
- source outcome index
- 4
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Percentage of Patients With Clinical Benefit Response
- measure definition
- Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either: (a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain. With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change. Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
- time frame
- Randomization to treatment discontinuation.The maximum time in follow up was 25 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR: * baseline pain intensity ≥ 20 (out of 100) * baseline morphine consumption ≥ 10 mg/day PO morphine equivalents * baseline KPS of 70 to 90 points
- 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-avgemsi-9fcc56af
- nct id
- NCT01494506
- qol key
- qol-0006
- source section id
- NCT01494506-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC-QLQ-C30
- measure definition
- This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.
- time frame
- Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice