A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
A Phase 1 Study to Evaluate the Safety of OBP-301, Telomelysin in Combination With Radiation Therapy in Patients With Esophageal Cancer Not Applicable for Standard Therapy
1 other identifier
interventional
12
1 country
2
Brief Summary
This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in combination with radiation therapy in patient with esophageal cancer who are not applicable to standard therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2017
CompletedStudy Start
First participant enrolled
July 7, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedSeptember 26, 2018
September 1, 2018
1.6 years
July 6, 2017
September 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Occurrence of Dose Limiting Toxicity
Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy
18 weeks
Incidence rate of adverse event
Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy
18 weeks
Secondary Outcomes (2)
Tumor response in the treatment objected lesion
18 weeks
Tumor response
18 weeks
Study Arms (1)
OBP-301 + Radiation
EXPERIMENTALOBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma.
- Patients are feasible for injection of OBP-301 into target legion
- Patients aged in 20 to 89 years.
- Patients with ECOG Performance Status Score ≤ 2.
- Patient who have life expectancy longer than 12 weeks.
- Patients who are not applicable to standard therapy.
- Patients who have adequate organ function.
You may not qualify if:
- Patients who have an active, treatment-required concomitant malignancy.
- Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs.
- Patients who have had chemotherapy within 4 weeks.
- Patients who have treatment history of cancer immunotherapy.
- Patients who had radiotherapy to treatment targeted lesion.
- Patients who have active infection which required systemic treatment.
- Patients who are scored III or IV by NYHA (New York Heart Association).
- Patients who are judged as inappropriate to this trial by investigator(s).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Research site
Kashima-shi, Chiba, Japan
Research site
Kita, Okayama-ken, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2017
First Posted
July 11, 2017
Study Start
July 7, 2017
Primary Completion
March 1, 2019
Study Completion
June 1, 2019
Last Updated
September 26, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share