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Clinical Trials List

Protocol NumberD910FC00001
NCT Number(ClinicalTrials.gov Identfier)NCT04078152

2019-06-01 - 2024-03-29

Phase IV

Recruiting5

An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Muh-Hwa Yang Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ching Yun Hsieh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YI-CHUN LIU Division of Radiation Therapy
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Solid Tumor

Objectives

The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.

Test Drug

IMFINZI (Durvalumab)

Active Ingredient

Durvalumab

Dosage Form

Solution for IV

Dosage

50 mg/mL durvalumab (MEDI4736)

Endpoints

Primary Outcome Measures:
1. Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0).

Secondary Outcome Measures:
1. Efficacy of durvalumab in terms of Overall Response Rate (ORR) in patients who undergo retreatment with durvalumab.
2. Efficacy of durvalumab in terms of Duration of Response (DOR) in patients who undergo retreatment with durvalumab.
3. Overall Survival (OS).

Inclution Criteria

atient must be 18 years or older, at the time of signing the ICF. For subjects aged < 20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative.
2. Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study.
3. Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen).
4. Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.

Exclusion Criteria

1. Currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab.
2. Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment.
3. Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study.
4. Diagnosis of a new primary malignancy since enrollment into the parent clinical study.

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    600 participants

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