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Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT02551991
Collaborator
(none)
56
Enrollment
27
Locations
1
Arm
65.5
Actual Duration (Months)
2.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Feb 15, 2021
Actual Study Completion Date :
Feb 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: nal-IRI + 5-FU/LV + oxaliplatin

Drug: nal-IRI
Other Names:
  • MM-398

    • Drug: 5 fluorouracil
    Other Names:
  • 5-FU

    • Drug: Leucovorin

    Drug: Oxaliplatin

    Outcome Measures

    Primary Outcome Measures

    1. Safety by reporting the adverse events and serious adverse events [Up to 18 months]

    2. Determine dose limiting toxicities (DLT) [Up to 28 Days post first treatment]

      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:

    Secondary Outcome Measures

    1. Pharmacokinetic Cmax of total irinotecan, SN-38 [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]

      Cmax (Observed maximal (peak) concentration)

    2. Pharmacokinetic Cavg of total irinotecan, SN-38 [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]

      Cavg (Average plasma concentration)

    3. Progression Free Survival (PFS) [up to 16 weeks post first treatment]

    4. Overall Survival (OS) [up to 16 weeks post first treatment]

      Duration from the date of enrolment/randomization to the time of death.

    5. Overall Response Rate (ORR) [up to 16 weeks post first treatment]

      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.

    6. Disease Control Rate (DCR) [up to 16 weeks post first treatment]

    7. Safety and adverse event profile [up to 18 months]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Mobile Alabama United States 36604
    2 University of South Alabama - Mobile Mobile Alabama United States 36688
    3 Arizona Center for Cancer Care Avondale Arizona United States 85392
    4 Mayo Clinic Cancer Center Scottsdale Arizona United States 85259
    5 University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center Orange California United States 92868
    6 University of California, Los Angeles (UCLA) Medical Center - Santa Monica Cancer Center Santa Monica California United States 90404
    7 University of Colorado (CU) Cancer Center - Anschutz Cancer Pavilion Aurora Colorado United States 80045
    8 Mayo Clinic Cancer Center - Jacksonville Jacksonville Florida United States 32224
    9 University of Miami Miami Florida United States 33136
    10 Mayo Clinic Cancer Center - Rochester Rochester Minnesota United States 55905
    11 US Oncology - Comprehensive Cancer Centers of Nevada (CCCN) Las Vegas Nevada United States 89169
    12 Holy Name Medical Center - Teaneck Teaneck New Jersey United States 07666
    13 Roswell Park Cancer Institute Buffalo New York United States 14263
    14 Levine Cancer Institute, Carolinas Healthcare System - Oncology Charlotte North Carolina United States 28204
    15 Wake Forest University Baptist Medical Center (WFUBMC) Winston-Salem North Carolina United States 27157
    16 University of Oklahoma Health Sciences Center (OUHSC) Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
    17 Gettysburg Cancer Center Gettysburg Pennsylvania United States 17325
    18 Medical Group of the Carolinas - Spartanburg Regional Health Services Spartanburg South Carolina United States 29303
    19 Houston Methodist Cancer Center and Institute of Academic Medicine Houston Texas United States 77030
    20 Oncology Consultants - Houston Houston Texas United States 77030
    21 Joe Arrington Cancer Research and Treatment Center - Lubbock Lubbock Texas United States 79410
    22 St. John of God Health Care - Subiaco Subiaco Western Australia Australia 6008
    23 Hospital General Universitario de Elche - Elche Elche Alicante Spain 03203
    24 Hospital Universitario de Fuenlabrada - Fuenlabrada Fuenlabrada Madrid Spain 28942
    25 Hospital Universitario Vall d'Hebron Barcelona Spain 08035
    26 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    27 Hospital Universitario Madrid Sanchinarro Centro Integral Oncologico Clara Campal (CIOCC) Madrid Spain 28050

    Sponsors and Collaborators

    • Ipsen

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT02551991
    Other Study ID Numbers:
    • MM-398-07-02-03
    • 2015-003086-28
    First Posted:
    Sep 16, 2015
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Ipsen
    Pancreatic cancer
    MM-398
    Metastatic pancreatic cancer
    First line pancreatic cancer treatment
    Additional relevant MeSH terms:
    Adenocarcinoma
    Pancreatic Neoplasms
    Leucovorin
    Fluorouracil
    Oxaliplatin

    Study Results

    No Results Posted as of Mar 10, 2022