Trials / Active Not Recruiting
Active Not RecruitingNCT03252808
Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients with Unresectable Pancreatic Cancer.
Phase I Study of Combination with TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Chemotherapy in Patients with Stage III or IV Unresectable Pancreatic Cancer.
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Takara Bio Inc. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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 patients with stage III or IV unresectable pancreatic cancer.
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | Gemcitabine | 1000 mg/m\^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest. |
| DRUG | Nab-paclitaxel | 125 mg/m\^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest. |
| 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. |
Timeline
- Start date
- 2017-09-25
- Primary completion
- 2020-02-19
- Completion
- 2035-03-31
- First posted
- 2017-08-17
- Last updated
- 2024-12-09
Locations
8 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03252808. Inclusion in this directory is not an endorsement.