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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

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ClinicalTrials.gov Identifier: NCT02551991
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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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
Pancreatic Cancer Drug: nal-IRI Drug: 5 fluorouracil Drug: Leucovorin Drug: Oxaliplatin Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : February 15, 2021
Actual Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: nal-IRI + 5-FU/LV + oxaliplatin Drug: nal-IRI
Other Name: MM-398

Drug: 5 fluorouracil
Other Name: 5-FU

Drug: Leucovorin
Drug: Oxaliplatin


Outcome Measures
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Primary Outcome Measures :
  1. Safety by reporting the adverse events and serious adverse events [ Time Frame: Up to 18 months ]
  2. Determine dose limiting toxicities (DLT) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: up to 16 weeks post first treatment ]
  4. Overall Survival (OS) [ Time Frame: up to 16 weeks post first treatment ]
    Duration from the date of enrolment/randomization to the time of death.

  5. Overall Response Rate (ORR) [ Time Frame: 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) [ Time Frame: up to 16 weeks post first treatment ]
  7. Safety and adverse event profile [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551991


Locations
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Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02551991    
Other Study ID Numbers: MM-398-07-02-03
2015-003086-28 ( EudraCT Number )
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Keywords provided by Ipsen:
Pancreatic cancer
MM-398
Metastatic pancreatic cancer
First line pancreatic cancer treatment
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Fluorouracil
 Oxaliplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients