Chemotherapy Combination for Pancreatic Cancer

(NAPOLI 3 Trial)

Recruiting at 244 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ipsen

Must not be taking: CYP3A inhibitors, CYP2C8 inducers

Disqualifiers: CNS metastases, Second malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: Until progression or unacceptable toxicity

770 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.

Research Team

Ipsen Medical Director

Principal Investigator

Ipsen

Eligibility Criteria

This trial is for adults with a recent diagnosis of metastatic pancreatic cancer who haven't been treated for it before. They should have measurable tumors, be in good physical condition (ECOG 0 or 1), and have normal blood counts, liver and kidney function. People can't join if they've had only localized disease, certain other cancers within the last two years, or used strong drug inhibitors/inducers recently.

Inclusion Criteria

I have at least one cancer spot that can be measured on a scan.

My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

My pancreatic cancer is confirmed and untreated in its advanced stage.

Exclusion Criteria

My body has low or no DPD enzyme activity.

I have a history of cancer spreading to my brain or spinal cord.

Concurrent illnesses that would be a relative contraindication to trial participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive either Irinotecan liposome injection with 5-FU/LV and oxaliplatin or nab-paclitaxel with gemcitabine in 28-day cycles until progression or unacceptable toxicity

Until progression or unacceptable toxicity

3 visits per cycle (in-person)

Follow-up

Participants are monitored for overall survival and progression-free survival every 8 weeks after the first dose, and every 2 months after the end of treatment

Up to 893 days

Every 8 weeks, then every 2 months

Treatment Details

Interventions

• 5Fluorouracil
• Gemcitabine
• Irinotecan Liposomal Injection
• Leucovorin
• Nab-paclitaxel
• Oxaliplatin

Trial Overview The study tests Irinotecan liposome injection combined with 5-fluorouracil/Leucovorin and Oxaliplatin against Nab-paclitaxel plus Gemcitabine treatment to see which is better at improving survival rates in patients with untreated metastatic pancreatic cancer.

Participant Groups

Group I: Irinotecan liposome injection + Oxaliplatin + 5-FU/LV Experimental Treatment 4 Interventions

Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity).

Group II: Nab-paclitaxel + Gemcitabine Active Control 2 Interventions

Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity).

5Fluorouracil is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Efudex for:

• Actinic keratosis
• Basal cell carcinoma

Approved in Canada as Efudex for:

• Actinic keratosis
• Basal cell carcinoma

Approved in United States as Adrucil for:

• Anal Cancer
• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Nasopharyngeal Carcinoma
• Pancreatic Cancer
• Stomach Cancer

Approved in European Union as Fluorouracil for:

• Actinic keratosis
• Basal cell carcinoma
• Anal Cancer
• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Nasopharyngeal Carcinoma
• Pancreatic Cancer
• Stomach Cancer

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD