Last updated: April 2, 2024
Sponsor: Osaka University
Overall Status: Active - Recruiting
Phase
1
Condition
Thyroid Cancer
Treatment
Targeted alpha therapy
Clinical Study ID
NCT05275946
AT1-001
Ages < 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with differentiated thyroid cancer (papillary cancer, follicular cancer)after total thyroidectomy who meet the following conditions (1) resistance to standardtreatment or (2) difficulty in continuing standard treatment (1) Patients who arerefractory to standard treatment such as 131I-NaI treatment Insufficient therapeuticeffect after 3 or more 131I-NaI treatments. 131I-NaI treatment resistance anddifficulty in performing or continuing tyrosine kinase inhibitor (TKI) treatment (2)Patients who have difficulty continuing standard treatment such as 131I-NaI treatmentAblation for residual thyroid or 131I-NaI treatment for relapsed / metastatic lesionshas been performed, but relapsed / metastatic lesions were observed at the time ofparticipation in this study, and 131I-NaI is the standard treatment. If it isdifficult to continue treatment or if local radiation therapy (including addition) isnot indicated (if it is not 131I-NaI treatment resistant, TKI treatment is notindicated).
- Patients aged 18 years or older at the time of consent acquisition
- Patients with stable general condition with PS (Performance status) of 0 to 2 in ECOG (Eastern Cooperative Oncology Group)
- Patients who can be expected to survive for 6 months or more, judging from clinicalsymptoms and medical examination findings
- Patients with no or controlled brain metastases with symptoms
- Patients with no clinically significant abnormal findings in electrocardiogram,respiratory rate, and blood oxygen saturation within 30 days before registration
- Patients whose laboratory values within 30days before the enrollment are within therange specified in the protocol
- Patients who thoroughly listened to the explanation of the clinical trial, agreed tothe examination, visit during the observation period and follow-up survey,contraception during the clinical trial period, etc. according to the clinical trialprotocol, and signed the consent document.
Exclusion
Exclusion Criteria:
- Patients who need fertility preservation
- Pregnant or potentially pregnant women, lactating patients
- Patients with active double cancer (simultaneous double cancer and ectopic doublecancer with a disease-free period of 5 years or less)
- Patients who received other investigational or unapproved drugs within 5 weeks priorto enrollment
- Patients who received chemotherapy, immunotherapy or radiation therapy within 8 weeksprior to enrollment in this study
- Patients with uncontrollable active infections
- HBsAg positive, HCV antibody positive or HIV antibody positive patients
- Patients with mental illness or psychiatric symptoms who are judged to be difficult toparticipate in clinical trials
- Other patients who are judged to be inappropriate by the investigator, etc.
Study Design
Total Participants: 11
Treatment Group(s): 1
Primary Treatment: Targeted alpha therapy
Phase: 1
Study Start date:
November 20, 2021
Estimated Completion Date:
September 30, 2025
Study Description
Connect with a study center
Osaka University Hospital
Suita, 565-0871
JapanActive - Recruiting
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