Clinical Trials List
2023-03-01 - 2025-09-30
Phase III
Recruiting5
ICD-10C00.0
Malignant neoplasm of external upper lip
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9140.0
Malignant neoplasm of upper lip, vermilion border
ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chih-Yen Tu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- JENG-SEN TSENG Division of Radiation Therapy
- KUO-HSUAN HSU Division of Radiation Therapy
- 鄭皓升 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shang-Yin Wu
- Wen-Pin Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Liang Wang Division of Hematology & Oncology
- Ping-Chih Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-I Shen Division of Thoracic Medicine
- Chi-Lu Chiang Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
2. Patient is currently deriving clinical benefit, as judged by the investigator, from continued treatment in an AstraZeneca parent study using an AstraZeneca compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study’s protocol.1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
2. Currently receiving treatment with any prohibited medication(s).
3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
4. Permanent discontinuation from the parent study due to toxicity or disease progression.
5. Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
Note: In countries where, according to local institutional requirements, it is not feasible to switch patients to the commercial drug through prescription, even if fully reimbursed, patients are eligible to participate in the ROSY study.
The additional exclusion criteria for the ROSY-D sub-study are:
6. Active infection including COVID-19 (PCR confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive HBsAg result), hepatitis C, or HIV (positive HIV 1/2 antibodies).
7. Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
8. Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ? 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, per Toxicity Dose Modification and TMGs for Immune-mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
Exclusion Criteria
The Core Protocol exclusion criteria are.
Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
Currently receiving treatment with any prohibited medication(s).
Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [example: Response Evaluation Criteria in Solid Tumours] progression or clinical progression).
Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
The additional exclusion criteria for the ROSY-D sub-study are:
Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).
Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
The Estimated Number of Participants
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Taiwan
7 participants
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Global
147 participants
