Phase II of BAX2398/5-FU/Calcium Levofolinate in Pancreatic Cancer

NCT ID: NCT02697058

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-30
• Study Completion Date: 2018-08-28

Brief Summary

Study Part 1: To assess the safety and tolerability, and to characterize the pharmacokinetics (PK) of BAX2398 in combination with 5-FU/calcium levofolinate in Japanese patients.

Study Part 2: To compare the efficacy of BAX2398 in combination with 5-FU/calcium levofolinate versus 5-FU/calcium levofolinate as assessed by Progression Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Safety and PK

BAX2398 in combination with 5-FU/calcium levofolinate

Group Type: EXPERIMENTAL

BAX2398 + 5-FU/calcium levofolinate

Intervention Type: BIOLOGICAL

BAX2398 (a liposomal formulation of irinotecan) in combination with 5-FU/calcium levofolinate

Part 2: Safety, PK, Efficacy

BAX2398 in combination with 5-FU/calcium levofolinate

Group Type: EXPERIMENTAL

BAX2398 + 5-FU/calcium levofolinate

Intervention Type: BIOLOGICAL

BAX2398 (a liposomal formulation of irinotecan) in combination with 5-FU/calcium levofolinate

Part 2: 5-FU/calcium levofolinate alone

5-FU/calcium levofolinate

Group Type: ACTIVE_COMPARATOR

5-FU/calcium levofolinate

Intervention Type: DRUG

5-FU/calcium levofolinate alone

Interventions

BAX2398 + 5-FU/calcium levofolinate

BAX2398 (a liposomal formulation of irinotecan) in combination with 5-FU/calcium levofolinate

Intervention Type: BIOLOGICAL

5-FU/calcium levofolinate

5-FU/calcium levofolinate alone

Intervention Type: DRUG

Other Intervention Names

nal-IRI; MM-398

Eligibility Criteria

Inclusion Criteria

1. Participant is ≥20 years of age at the time of screening.

2. Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas

3. Documented metastatic disease

4. Metastatic disease with at least one measurable lesion as defined by RECIST 1.1 guidelines

5. Documented disease progression after prior gemcitabine or any gemcitabine containing therapy but excluding irinotecan, for locally advanced or metastatic setting. Prior chemotherapy must be stopped for at least 21 days before the first dose.

6. Karnofsky Performance Status (KPS) ≥70

7. Adequate bone marrow reserves

8. Adequate hepatic function

9. Adequate renal function

10. Normal ECG including Fridericia corrected QT interval (QTcF) <440 ms within 7 days prior to first dose of study drug

11. Recovered from the effects of any prior surgery, radiotherapy or other anti-neoplastic therapy with no residual adverse events (AEs) of Grade ≥2.

12. Able to understand and sign an informed consent (or have a legal representative who is able to do so)

13. If female of childbearing potential, participant presents with a negative pregnancy, and agrees to employ adequate birth control measures during the study dosing period and for 3 months following the last dose of study drug.

14. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria

1. Active and uncontrolled central nervous system (CNS) metastases; for controlled CNS metastases, patient should have been off steroids for at least 28 days prior to starting study therapy.

2. History of any second malignancy in the last 5 years; participants with prior history of in-situ cancer or basal or squamous cell skin cancers are eligible. Participants with other malignancies are eligible if they have been continuously disease free for at least 5 years.

3. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion.

4. Cannot stop medications that are potent CYP3A4 inducers within 2 weeks and inhibitors within 1 week before start of treatment.

5. Significant cardiac conduction abnormalities, including a history of long QTcF syndrome and/or pacemaker.

6. New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure.

7. Active infection, including active hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV, or an unexplained fever >38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled), which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome.

8. Known hypersensitivity to any of the components of BAX2398, other liposomal products, fluoropyrimidines, or calcium levofolinate.

9. Any other medical or social condition deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

10. Participant has been exposed to an investigational product (IP) within 30 days prior to the first dose of the study drug or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.

11. Participant is a family member or employee of the investigator.

12. Participant is pregnant or lactating at the time of enrollment. Lactating mothers can resume breast feeding 30 days following the last dose of the study treatment.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADIR, a Servier Group company

INDUSTRY

Sponsor Role: collaborator

Institut de Recherches Internationales Servier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hirosaki University School of Medicine & Hospital

Hirosaki-shi, Aomori, Japan

Chiba Cancer Center

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

NHO Shikoku Cancer Center

Matsuyama, Ehime, Japan

NHO Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa -ku, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

NHO Osaka National Hospital

Osaka, Osaka, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Saitama Cancer Center

Kitaadachi-gun, Saitama, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Tokyo-To, Japan

Kyorin University Hospital

Mitaka-shi, Tokyo-To, Japan

Countries

Japan

References

Ueno M, Nakamori S, Sugimori K, Kanai M, Ikeda M, Ozaka M, Furukawa M, Okusaka T, Kawabe K, Furuse J, Komatsu Y, Ishii H, Sato A, Shimizu S, Chugh P, Tang R, Ioka T. nal-IRI+5-FU/LV versus 5-FU/LV in post-gemcitabine metastatic pancreatic cancer: Randomized phase 2 trial in Japanese patients. Cancer Med. 2020 Dec;9(24):9396-9408. doi: 10.1002/cam4.3558. Epub 2020 Oct 25.

Reference Type: BACKGROUND

PMID: 33099898 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: study-level clinical trial data

View Document

Other Identifiers

331501

Identifier Type: -

Identifier Source: org_study_id