Phase 3
Completed N=417
Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT01494506 ↗Enrolled (actual)
417
Serious AEs
51.3%
Results posted
Feb 2016
Primary outcomePrimary: Overall Survival — 4.9; 4.2; 6.1; 4.2 months — p=0.9416
Summary
The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
4.9; 4.2; 6.1; 4.2 | 0.9416 |
| SECONDARY Progression Free Survival |
2.7; 1.6; 3.1; 1.5 | 0.100 |
| SECONDARY Objective Response Rate |
3.31; 0.67; 7.69; 0.84 | 0.214 |
| SECONDARY Time to Treatment Failure |
1.7; 1.4; 2.3; 1.4 | 0.1008 |
| SECONDARY Percentage of Patients With Clinical Benefit Response |
14; 13; 14; 12 | 0.82 |
| SECONDARY Percentage of Patients With Tumor Marker (CA 19-9) Response |
23.6; 11.4; 28.9; 8.6 | 0.024 sig |
| SECONDARY EORTC-QLQ-C30 |
10; 11; 17; 12; 31; 41 | 0.6388 |
| SECONDARY Pharmacokinetic Measurements of Total Irinotecan |
2550.00; 2120.00; 40550.00; 28460.00; 0.82; 0.68 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
- Metastatic disease
- Documented disease progression after prior gemcitabine based therapy
- KPS >/= 70
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
Exclusion Criteria
- Active CNS metastasis
- Clinically significant GI disorders
- Severe arterial thromboembolic events less than 6 months before inclusion
- NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
- Active infection or uncontrolled fever
- Pregnant or breast feeding patients
Data sourced from ClinicalTrials.gov (NCT01494506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.