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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01494506




Registration number
NCT01494506
Ethics application status
Date submitted
14/12/2011
Date registered
19/12/2011
Date last updated
17/06/2016

Titles & IDs
Public title
Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
Scientific title
A Randomized, Open Label Phase 3 Study of MM-398, With or Without 5-Fluorouracil and Leucovorin, Versus 5 Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer Who Have Failed Prior Gemcitabine-based Therapy
Secondary ID [1] 0 0
MM-398-07-03-01
Universal Trial Number (UTN)
Trial acronym
NAPOLI-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MM-398
Treatment: Drugs - 5 Fluorouracil
Treatment: Drugs - Leucovorin

Experimental: MM-398 - MM-398 120 mg/m2 Q3W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 120 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 100 mg/ m2 of irinotecan free base.

Active comparator: 5 Fluorouracil and Leucovorin IV - 5 Fluorouracil and Leucovorin IV

Experimental: MM-398, 5-FU and Leucovorin - MM-398 80 mg/m2, 5-FU and Leucovorin Q2W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 80 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 70 mg/ m2 of irinotecan free base.


Treatment: Drugs: MM-398
Arm A: MM-398 120 mg/m2 IV Q3W

Arm C: MM-398 80mg/m2 IV Q2W

Treatment: Drugs: 5 Fluorouracil
Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks

Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks

Treatment: Drugs: Leucovorin
Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks

Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Objective Response Rate
Timepoint [2] 0 0
Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months.
Secondary outcome [3] 0 0
Time to Treatment Failure
Timepoint [3] 0 0
Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months
Secondary outcome [4] 0 0
Percentage of Patients With Clinical Benefit Response
Timepoint [4] 0 0
Randomization to treatment discontinuation.The maximum time in follow up was 25 months
Secondary outcome [5] 0 0
Percentage of Patients With Tumor Marker (CA 19-9) Response
Timepoint [5] 0 0
Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
Secondary outcome [6] 0 0
EORTC-QLQ-C30
Timepoint [6] 0 0
Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
Secondary outcome [7] 0 0
Pharmacokinetic Measurements of Total Irinotecan
Timepoint [7] 0 0
6 weeks after first study drug administration

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
417
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
- Westmead
Recruitment hospital [2] 0 0
- Kurralta Park
Recruitment hospital [3] 0 0
- Boxhill
Recruitment hospital [4] 0 0
- Heidelberg
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- Kurralta Park
Recruitment postcode(s) [3] 0 0
- Boxhill
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
State/province [3] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Virginia
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Rosario
Country [16] 0 0
Argentina
State/province [16] 0 0
Santa Fe
Country [17] 0 0
Brazil
State/province [17] 0 0
Belo Horizonte
Country [18] 0 0
Brazil
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Ijui
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Sao Paulo
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Canada
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Quebec
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Czech Republic
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Horovice
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Czech Republic
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Olomouc
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Czech Republic
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Prague
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Czech Republic
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Pribram
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France
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Bordeaux
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France
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Lille
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France
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Marseille
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Germany
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Berlin
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Germany
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Jens
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Germany
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Munich
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Germany
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Ulm
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Hungary
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Budapest
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Hungary
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Pecs
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Hungary
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Szeged
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Hungary
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Szolnok
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Hungary
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Szombathely
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Italy
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Castellana Grotte
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Italy
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Genova
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Italy
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Legnano
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Italy
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Naples
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Italy
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Roma
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Korea, Republic of
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Hwasun-gun
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Korea, Republic of
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Seoul
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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South Africa
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Western Cape
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Spain
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Alicante
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Spain
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Barcelona
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Madrid
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Spain
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Santander
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Spain
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Valencia
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Taiwan
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Chiayi
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Taiwan
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Kaohsiung
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Taiwan
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Taiching
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Taiwan
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Tainan
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Taiwan
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Taipei
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taoyuan
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Liverpool
Country [61] 0 0
United Kingdom
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London
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United Kingdom
State/province [62] 0 0
Manchester
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United Kingdom
State/province [63] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merrimack Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eliel Bayever, MD
Address 0 0
Merrimack Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01494506