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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02551991




Registration number
NCT02551991
Ethics application status
Date submitted
10/09/2015
Date registered
16/09/2015
Date last updated
29/03/2019

Titles & IDs
Public title
Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Scientific title
A Randomized, Open-label Phase 2 Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-Paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Secondary ID [1] 0 0
MM-398-07-02-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - nal-IRI
Treatment: Drugs - 5 fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - Oxaliplatin

Experimental: nal-IRI + 5-FU/LV + oxaliplatin -


Treatment: Drugs: nal-IRI


Treatment: Drugs: 5 fluorouracil


Treatment: Drugs: Leucovorin


Treatment: Drugs: Oxaliplatin


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety by reporting the adverse events and serious adverse events
Timepoint [1] 0 0
Up to 18 months
Primary outcome [2] 0 0
Determine dose limiting toxicities (DLT) - For nal-IRI administered in combination with 5-FU/LV and oxaliplatin, the following adverse events will be considered as dose limiting toxicities (DLTs) if the following adverse events occur within 28 days of Cycle 1 or 14 days after Cycle 2 of treatment and are deemed related to the study treatment regimen:
Timepoint [2] 0 0
Up to 28 Days post first treatment
Secondary outcome [1] 0 0
Pharmacokinetic Cmax of total irinotecan, SN-38 and oxaliplatin - Cmax (Observed maximal (peak) concentration)
Timepoint [1] 0 0
Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose
Secondary outcome [2] 0 0
Pharmacokinetic Cavg of total irinotecan, SN-38 and oxaliplatin - Cavg (Average plasma concentration)
Timepoint [2] 0 0
Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose
Secondary outcome [3] 0 0
Pharmacokinetic Cmin of total irinotecan, SN-38 and oxaliplatin - Cmin (Minimum plasma concentration)
Timepoint [3] 0 0
Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose
Secondary outcome [4] 0 0
Pharmacokinetic AUCt of total irinotecan, SN-38 and oxaliplatin - AUCt (Area under the plasma concentration time curve within a dosage interval (0 to last measurable concentration))
Timepoint [4] 0 0
Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose
Secondary outcome [5] 0 0
Pharmacokinetic CL of total irinotecan, SN-38 and oxaliplatin - CL (apparent total body clearance of the drug from plasma after administration)
Timepoint [5] 0 0
Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose
Secondary outcome [6] 0 0
Pharmacokinetic Vd of total irinotecan, SN-38 and oxaliplatin - Vd (apparent volume distribution after administration)
Timepoint [6] 0 0
Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose
Secondary outcome [7] 0 0
Progression Free Survival (PFS)
Timepoint [7] 0 0
up to 16 weeks post first treatment
Secondary outcome [8] 0 0
Overall Survival (OS) - Duration from the date of enrolment/randomization to the time of death.
Timepoint [8] 0 0
up to 16 weeks post first treatment
Secondary outcome [9] 0 0
Overall Response Rate (ORR) - Proportion of patients with Best overall response (BOR) characterized as either a Complete or Partial Response (CR or PR) relative to the total number of evaluable patients.
Timepoint [9] 0 0
up to 16 weeks post first treatment
Secondary outcome [10] 0 0
Disease Control Rate (DCR)
Timepoint [10] 0 0
up to 16 weeks post first treatment
Secondary outcome [11] 0 0
Safety and adverse event profile - The incidence of adverse events will be summarized by type of adverse event and severity. All patients who have received at least one dose of irinotecan liposome injection will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE)
Timepoint [11] 0 0
up to 18 months

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not
been previously treated in the metastatic setting

- Unresectable, locally advanced or metastatic disease; diagnosed within 6 weeks prior
to screening

- At least one tumor lesion measurable by CT or MRI scan (according to RECIST v1.1)

- ECOG performance status of 0 or 1 at screening and within 72 hours prior to first dose
if first dose occurs more than 72 hours post-screening

- Adequate hematological, hepatic, renal and cardiac function

- Recovered from the effects of any prior surgery or radiotherapy

- Patient has a Karnofsky performance status (KPS) = 70 at Screening, and within 72
hours prior to date of first dose if first dose occurs more than 72 hours after
screening (Part 1B only)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment of pancreatic cancer in the metastatic setting (or locally advanced
setting) with surgery (placement of stent is allowed), radiotherapy, chemotherapy or
investigational therapy

- Prior treatment of pancreatic cancer with chemotherapy in adjuvant setting, except
those where at least 12 months have elapsed since completion of the last dose and no
persistent treatment-related toxicities present

- Uncontrolled Central Nervous System (CNS) metastases

- Clinically significant gastrointestinal disorder

- History of any second malignancy in the last 3 years. Patients with prior history of
in-situ cancer or basal or squamous cell skin cancer are eligible

- Presence of any contraindications for nal-IRI, irinotecan, 5-FU, leucovorin,
oxaliplatin

- Use of strong CYP3A4 or inducers or presence of any other contra indications for
irinotecan

- Pregnant or breast feeding

- Neuroendocrine or acinar pancreatic carcinoma

- Serum albumin < 3 g/dL at screening visit and within 72 hours prior to first dose if
first dose occurs more than 72 hours post screening

- Patients with symptoms and signs of clinically unacceptable deterioration of primary
disease at time of screening

- Previous treatment with irinotecan-based, nab-paclitaxel-based or gemcitabine-based
resulting in disease progression

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
St. John of God Health Care - Subiaco - Subiaco
Recruitment postcode(s) [1] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Spain
State/province [14] 0 0
Alicante
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, phase 2 comparative study to assess the safety, tolerability, and
preliminary efficacy of nal-IRI in combination with other anticancer therapies in patients
not previously treated for metastatic pancreatic adenocarcinoma. This study will assess the
following regimen:

• nal-IRI + 5-fluorouracil (5-FU)/leucovorin (LV) + oxaliplatin

The study will be conducted in two parts:

1. Part 1a: a safety run-in as initial dose exploration

2. Part 1b: dose expansion of the nal-IRI + 5FU/LV + oxaliplatin regimen
Trial website
https://clinicaltrials.gov/show/NCT02551991
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
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

Summary results
Other publications