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

NCT02697058 | Completed Phase 2 DMC

• 1 other identifier: 331501
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 16

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) in Part 2 of Study

  Progression Free Survival (PFS) was defined as the time from randomization to the first documented disease progression based on the independent central review board's assessment using RECIST 1.1 or death due to any cause, whichever occurred first.

  Part 2 Baseline to the end of the study (up to 22 months)

Secondary Outcomes (39)

• Progression Free Survival (PFS) in Part 1 of Study

  Part 1 Baseline to the end of the study (up to 22 months)

• Overall Survival (OS)

  Baseline to the end of the study (up to 22 months)

• Time to Treatment Failure (TTF)

  Baseline to the end of the study (up to 22 months)

• Objective Response Rate (ORR)

  Baseline to the end of the study (up to 22 months)

• Disease Control Rate (DCR)

  Baseline to the end of the study (up to 22 months)

Study Arms (3)

Part 1: Safety and PK

EXPERIMENTAL

BAX2398 in combination with 5-FU/calcium levofolinate

Biological: BAX2398 + 5-FU/calcium levofolinate

Part 2: Safety, PK, Efficacy

EXPERIMENTAL

BAX2398 in combination with 5-FU/calcium levofolinate

Biological: BAX2398 + 5-FU/calcium levofolinate

Part 2: 5-FU/calcium levofolinate alone

ACTIVE COMPARATOR

5-FU/calcium levofolinate

Drug: 5-FU/calcium levofolinate

Interventions

BAX2398 + 5-FU/calcium levofolinate BIOLOGICAL

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

Also known as: nal-IRI, MM-398

Part 1: Safety and PK; Part 2: Safety, PK, Efficacy

5-FU/calcium levofolinate DRUG

5-FU/calcium levofolinate alone

Part 2: 5-FU/calcium levofolinate alone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is ≥20 years of age at the time of screening.
• Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
• Documented metastatic disease
• Metastatic disease with at least one measurable lesion as defined by RECIST 1.1 guidelines
• 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.
• Karnofsky Performance Status (KPS) ≥70
• Adequate bone marrow reserves
• Adequate hepatic function
• Adequate renal function
• Normal ECG including Fridericia corrected QT interval (QTcF) \<440 ms within 7 days prior to first dose of study drug
• Recovered from the effects of any prior surgery, radiotherapy or other anti-neoplastic therapy with no residual adverse events (AEs) of Grade ≥2.
• Able to understand and sign an informed consent (or have a legal representative who is able to do so)
• 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.
• Participant is willing and able to comply with the requirements of the protocol.

You may not qualify if:

• 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.
• 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.
• Cannot stop medications that are potent CYP3A4 inducers within 2 weeks and inhibitors within 1 week before start of treatment.
• Significant cardiac conduction abnormalities, including a history of long QTcF syndrome and/or pacemaker.
• New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure.
• 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.
• Known hypersensitivity to any of the components of BAX2398, other liposomal products, fluoropyrimidines, or calcium levofolinate.
• 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.
• 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.
• Participant is a family member or employee of the investigator.
• 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.

Sponsors & Collaborators

• Institut de Recherches Internationales Servier: lead
• ADIR, a Servier Group company: collaborator

Study Sites (16)

Hirosaki University School of Medicine & Hospital

Hirosaki-shi, Aomori, 036-8563, Japan

Location

Chiba Cancer Center

Chiba, Chiba, 260-8717, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

NHO Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

NHO Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa -ku, 241-8515, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

NHO Osaka National Hospital

Osaka, Osaka, 540-0006, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

Saitama Cancer Center

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital of JFCR

Kōtoku, Tokyo-To, 135-8550, Japan

Location

Kyorin University Hospital

Mitaka-shi, Tokyo-To, 181-8611, Japan

Location

Related Publications (1)

• 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.

  PMID: 33099898 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2016
• First Posted: March 3, 2016
• Study Start: March 30, 2016
• Primary Completion: May 4, 2017
• Study Completion: August 28, 2018
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

Locations

JP (16)