Trial · NCT01494506
Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
NCT01494506, Phase 3, Completed, Merrimack Pharmaceuticals; results first posted 2016-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer. Trials, record NCT01494506. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01494506
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
- NCT number
- NCT01494506
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 417 participants, actual
- Lead sponsor
- Merrimack Pharmaceuticals
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- MM-398, 5 Fluorouracil, Leucovorin
- First posted
- 2011-12-19
- Last updated
- 2016-06-17
- Results first posted
- 2016-02-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months. | 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. |
| Secondary | Progression Free Survival | 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. | 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. |
| Secondary | Objective Response Rate | Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months. | 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. |
| Secondary | Time to Treatment Failure | Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months | Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death. |
| Secondary | Percentage of Patients With Clinical Benefit Response | Randomization to treatment discontinuation.The maximum time in follow up was 25 months | 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. |
| Secondary | Percentage of Patients With Tumor Marker (CA 19-9) Response | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months | 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. |
| Secondary | EORTC-QLQ-C30 | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months | 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. |
| Secondary | Pharmacokinetic Measurements of Total Irinotecan | 6 weeks after first study drug administration | Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months. | 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. | months | MEDIAN |
| SECONDARY | Progression Free Survival | 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. | ITT Population | months | MEDIAN |
| SECONDARY | Objective Response Rate | Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months. | ITT Population | percentage with confirmed response | NUMBER |
| SECONDARY | Time to Treatment Failure | Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months | ITT Population | months | MEDIAN |
| SECONDARY | Percentage of Patients With Clinical Benefit Response | Randomization to treatment discontinuation.The maximum time in follow up was 25 months | 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 | percentage of participants with CBR | NUMBER |
| SECONDARY | Percentage of Patients With Tumor Marker (CA 19-9) Response | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months | Patients with elevated baseline CA19-9 value (\> 30 U/mL) who received study drug. | percent of participants with TMR | NUMBER |
| SECONDARY | EORTC-QLQ-C30 | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months | ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment. | percent of patients in category | NUMBER |
| SECONDARY | Pharmacokinetic Measurements of Total Irinotecan | 6 weeks after first study drug administration | PK population was based on Protocol, all participants who received the appropriate dose of MM-398. | Total irinotecan = ug/L; SN38= ug/L | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group212
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | MM-398 Arm A (Mono Therapy Comparison) | 4.9 | 95% Confidence Interval 4.23 to 5.62 | months | |
| Overall Survival | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 4.2 | 95% Confidence Interval 3.58 to 4.86 | months | |
| Overall Survival | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 6.1 | 95% Confidence Interval 4.76 to 8.87 | months | |
| Overall Survival | 5-FU + Leucovorin (Combo Therapy Comparison) | 4.2 | 95% Confidence Interval 3.29 to 5.32 | months | |
| Progression Free Survival | MM-398 Arm A (Mono Therapy Comparison) | 2.7 | 95% Confidence Interval 2.13 to 2.89 | months | |
| Progression Free Survival | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 1.6 | 95% Confidence Interval 1.41 to 1.84 | months | |
| Progression Free Survival | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 3.1 | 95% Confidence Interval 2.69 to 4.17 | months | |
| Progression Free Survival | 5-FU + Leucovorin (Combo Therapy Comparison) | 1.5 | 95% Confidence Interval 1.41 to 1.84 | months | |
| Objective Response Rate | MM-398 Arm A (Mono Therapy Comparison) | 3.31 | 95% Confidence Interval 0.46 to 6.17 | percentage with confirmed response | |
| Objective Response Rate | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 0.67 | 95% Confidence Interval 0.0 to 1.98 | percentage with confirmed response |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MM-398 (Arm A) | 151 | |
| Overall Study | STARTED | 5-FU + Leucovorin (Arm B) | 149 | |
| Overall Study | STARTED | MM-398 + 5-FU + Leucovorin (Arm C) | 117 | |
| Overall Study | Treated Population | MM-398 (Arm A) | 147 | |
| Overall Study | Treated Population | 5-FU + Leucovorin (Arm B) | 134 | |
| Overall Study | Treated Population | MM-398 + 5-FU + Leucovorin (Arm C) | 117 | |
| Overall Study | COMPLETED | MM-398 (Arm A) | 3 | |
| Overall Study | COMPLETED | 5-FU + Leucovorin (Arm B) | 6 | |
| Overall Study | COMPLETED | MM-398 + 5-FU + Leucovorin (Arm C) | 14 | |
| Overall Study | NOT COMPLETED | MM-398 (Arm A) | 148 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events264
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 | Diarrhoea | Gastrointestinal disorders | MM-398 | 103 | 147 | |
| other | Diarrhoea | Gastrointestinal disorders | 5 Fluorouracil and Leucovorin IV | 35 | 134 | |
| other | Diarrhoea | Gastrointestinal disorders | MM-398, 5-FU and Leucovorin | 116 | 117 | |
| other | Vomiting | Gastrointestinal disorders | MM-398 | 80 | 147 | |
| other | Vomiting | Gastrointestinal disorders | 5 Fluorouracil and Leucovorin IV | 35 | 134 | |
| other | Vomiting | Gastrointestinal disorders | MM-398, 5-FU and Leucovorin | 61 | 117 | |
| other | Nausea | Gastrointestinal disorders | MM-398 | 89 | 147 | |
| other | Nausea | Gastrointestinal disorders | 5 Fluorouracil and Leucovorin IV | 46 | 134 | |
| other | Nausea | Gastrointestinal disorders | MM-398, 5-FU and Leucovorin | 60 | 117 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | MM-398 | 72 | 147 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MM-398 | ||
| Total, all-cause mortality | 5 Fluorouracil and Leucovorin IV | ||
| Total, all-cause mortality | MM-398, 5-FU and Leucovorin | ||
| Total, other adverse events | MM-398 | 145 | 147 |
| Total, other adverse events | 5 Fluorouracil and Leucovorin IV | 132 | 134 |
| Total, other adverse events | MM-398, 5-FU and Leucovorin | 116 | 117 |
| Total, serious adverse events | MM-398 | 90 | 147 |
| Total, serious adverse events | 5 Fluorouracil and Leucovorin IV | 58 | 134 |
| Total, serious adverse events | MM-398, 5-FU and Leucovorin | 56 | 117 |
Source ClinicalTrials.gov
Papers7
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT01494506/results?page=2