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Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Japanese Patients With Unresectable Pancreatic Cancer.

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ClinicalTrials.gov Identifier: NCT03252808
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Takara Bio Inc.

Brief Summary:
The purpose of this study is to determine the recommended dose of TBI-1401(HF10) treatment in combination with chemotherapy (Gemcitabine + Nab-paclitaxel or TS-1) in Japanese patients with stage III or IV unresectable pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Biological: TBI-1401(HF10) Drug: Gemcitabine Drug: Nab-paclitaxel Drug: TS-1 Phase 1

Detailed Description:

A Phase I, open-label, multi-center study to determine the recommended dose of TBI-1401(HF10) treatment in combination with chemotherapy (Gemcitabine + Nab-paclitaxel or TS-1) in Japanese patients with stage III or IV unresectable pancreatic cancer. Patients with stage IV must failed a gemcitabine based first-line chemotherapy.

Patients with stage III will receive the repeated intratumoral injection of TBI-1401(HF10) at recommended dose at 2-week intervals in combination with intravenous infusion of 1000 mg/m^2 Gemcitabine and 125 mg/m^2 Nab-paclitaxel at weekly for 3 weeks followed by 1 week rest.

Patients with stage IV will receive the repeated intratumoral injection of TBI-1401(HF10) at recommended dose at 2-week intervals in combination with oral of 40 - 60 mg TS-1 at twice daily for 4 weeks followed by 2 weeks rest.

Patients will receive the combination therapy of TBI-1401(HF10) + chemo for up to 1 year if eligible for treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Combination With TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Chemotherapy in Japanese Patients With Stage III or IV Unresectable Pancreatic Cancer.
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TBI-1401(HF10) + Gem/nab-PTX
1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered to the tumor in a total volume up to 2.0 mL (injection volume will be adjusted based on the tumor size) by EUS-guided intratumoral injection and 1000 mg/m^2 Gemcitabine and 125 mg/m^2 Nab-paclitaxel injected by intravenous infusions.
Biological: TBI-1401(HF10)
1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered by intratumoral injection at 2-week intervals. Patients may continue to receive the injections for up to 1 year if eligible for injection.
Other Names:
  • HF10
  • canerpaturev

Drug: Gemcitabine
1000 mg/m^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Other Name: Gemzar

Drug: Nab-paclitaxel
125 mg/m^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Other Name: Abraxane

Experimental: TBI-1401(HF10) + TS-1 (primary)
1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered to the primary tumor in a total volume up to 2.0 mL (injection volume will be adjusted based on the tumor size) by EUS-guided intratumoral injection and TS-1 administered by oral.
Biological: TBI-1401(HF10)
1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered by intratumoral injection at 2-week intervals. Patients may continue to receive the injections for up to 1 year if eligible for injection.
Other Names:
  • HF10
  • canerpaturev

Drug: TS-1
TS-1 (40-60 mg per body surface area) administered by oral at twice daily for 4 weeks followed by 2 weeks of rest.
Other Name: Tegafur-gimeracil-oteracil potassium

Experimental: TBI-1401(HF10) + TS-1 (primary and meta)
1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered to the primary tumor in a total volume up to 2.0 mL (injection volume will be adjusted based on the tumor size) by EUS-guided intratumoral injection and hepatic metastasis in a total volume up to 2.0 mL (injection volume will be adjusted based on the tumor size) by EUS-guided intratumoral injection or percutaneous injection and TS-1 administered by oral.
Biological: TBI-1401(HF10)
1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered by intratumoral injection at 2-week intervals. Patients may continue to receive the injections for up to 1 year if eligible for injection.
Other Names:
  • HF10
  • canerpaturev

Drug: TS-1
TS-1 (40-60 mg per body surface area) administered by oral at twice daily for 4 weeks followed by 2 weeks of rest.
Other Name: Tegafur-gimeracil-oteracil potassium




Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: Through 1st TBI-1401(HF10) injection to before 3rd injection (basically 4 weeks). ]
    Determine the recommended dose of TBI-1401(HF10) in combination with Gemcitabine and Nab-paclitaxel.


Secondary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Through 1st TBI-1401(HF10) injection to study completion (up to 13 month). ]
    Evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).

  2. Objective response rate (ORR) by RECIST [ Time Frame: At 16 weeks and through study completion (up to 1 year). ]
    Overall tumor response evaluated by RECIST version 1.1

  3. Objective response rate (ORR) by irRECIST [ Time Frame: At 16 weeks and through study completion (up to 1 year). ]
    Overall tumor response evaluated by irRECIST.

  4. Progression-free survival (PFS) by RECIST [ Time Frame: Through disease progression (up to 1 year). ]
    Evaluation the time to progression during and after the treatment.

  5. Progression-free survival (PFS) by irRECIST [ Time Frame: Through disease progression (up to 1 year). ]
    Evaluation the time to progression during and after the treatment.


Other Outcome Measures:
  1. Overall survival (OS) [ Time Frame: From 1st treatment to death (up to 2 years). ]
    Evaluation the overall survival.

  2. 1 year survival rate [ Time Frame: for 1 year. ]
    Determine the 1 year survival rate of patient who received treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed unresectable pancreatic cancer (stage III or IV) based on the General Rules for the Study of Pancreatic Cancer (The 7th edition), and never received anti-cancer therapy (radiation therapy, chemotherapy, immunotherapy, surgery, clinical trials).
  • Patients with primary lesion will be intratumorally injectable for TBI-1401(HF10) by EUS (endoscopic ultrasound).
  • Patients must be ≧20 years of age.
  • Patients must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment.
  • Patients must have a life expectancy ≧12 weeks.
  • Patients must have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0-1.
  • Patients demonstrated adequate organ function (≦7 days prior to treatment).
  • Females of childbearing potential must have a negative urine or serum pregnancy test within 1 week prior to start of treatment.
  • Patients must be able to understand the study and willing to sign a written informed consent document.

Exclusion Criteria:

  • Patients receiving anti-herpes medication within 1 week prior to TBI-1401(HF10) treatment (except local treatment such as ointment).
  • Patients with a significant tumor bleeding or coagulation abnormality that could not treat intratumoral injection or biopsy in safe.
  • Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis C virus (HCV) antibody positive and HSV-RNA positive, Human Immunodeficiency Virus (HIV) antibody positive.
  • Patients with the active symptom of Epstein-Barr virus (EBV) infection.
  • Patients with active CNS metastases.
  • Patients with ascites, except acceptable mild ascites.
  • Patients with multiple cancer.
  • Patients need to treat anticoagulant or antiplatelet agent.
  • Patients has a history of allergy for CT contrast agent, live vaccine, any drug excipients, Nab-paclitaxel, Gemcitabine, or any study drugs.

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): NCT03252808


Contacts
Contact: Takara Bio Inc. +81-77-565-6970 takara-clinical@takara-bio.co.jp

Locations
Japan
Clinical Site Recruiting
Nagoya, Aichi, Japan
Clinical Site Recruiting
Kashiwa, Chiba, Japan
Clinical Site Recruiting
Yokohama, Kanagawa, Japan
Clinical Site Recruiting
Chūōku, Tokyo, Japan
Clinical Site Recruiting
Nagoya, Japan
Clinical Site Recruiting
Osaka, Japan
Sponsors and Collaborators
Takara Bio Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Takara Bio Inc. Project Management Department

Responsible Party: Takara Bio Inc.
ClinicalTrials.gov Identifier: NCT03252808     History of Changes
Other Study ID Numbers: TBI1401-03
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takara Bio Inc.:
Tegafur-gimeracil-oteracil potassium
Unresectable pancreatic cancer
Metastatic pancreatic cancer
Pancreatic adenocarcinoma
TBI-1401(HF10)
HF10
Oncolytic virus
Oncolytic viral immunotherapy
Gemcitabine
Nab-paclitaxel
Albumin-bound paclitaxel
Abraxane
TS-1
canerpaturev

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Tegafur
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs