A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT03213054|
Recruitment Status : Unknown
Verified September 2018 by Oncolys BioPharma Inc.
Recruitment status was: Recruiting
First Posted : July 11, 2017
Last Update Posted : September 26, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Biological: OBP-301 Radiation: Radiation||Phase 1|
After screening, patients will undergo a combination therapy of OBP-301 with radiation therapy for 6 weeks. At Day 1, Day 18 and Day 32, OBP-301 is directly injected to the location of the lesion. From Day 4, patients receive radiation therapy. Patients will be automatically entered follow-up period for 12 weeks to be observed tolerance and safety.
This study is designated as standard 3 + 3 dose escalation study. The first 3 patients will be evaluated with low-dose of OBP-301 and then the study move onto the high-dose cohort of OBP-301. When the DLT (Dose Limiting Toxicity) is observed, 3 more patients will be enrolled in the dose level.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 7, 2017|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: OBP-301 + Radiation
OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.
OBP-301 administration on the Day 1, Day 18 and Day 32
Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks
- Occurrence of Dose Limiting Toxicity [ Time Frame: 18 weeks ]Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy
- Incidence rate of adverse event [ Time Frame: 18 weeks ]Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy
- Tumor response in the treatment objected lesion [ Time Frame: 18 weeks ]Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.
- Tumor response [ Time Frame: 18 weeks ]Tumor response as the best overall response of the record within 18 weeks from the start of treatment.
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|Ages Eligible for Study:||20 Years to 89 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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).
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): NCT03213054
|Contact: Yira Bermudez, PhD, MBA, RACemail@example.com|
|Kashima-shi, Chiba, Japan|
|Kita, Okayama, Japan|
|Responsible Party:||Oncolys BioPharma Inc|
|Other Study ID Numbers:||
|First Posted:||July 11, 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:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases