Actively Recruiting
Sacituzumab govitecan in Advanced Differentiated and Anaplastic Thyroid Cancer: A Phase II Multicenter Study Evaluating Efficacy and Safety
Led by Grupo Espanol de Tumores Neuroendocrinos · Updated on 2024-11-01
42
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Grupo Espanol de Tumores Neuroendocrinos
Lead Sponsor
M
MFAR
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating sacituzumab govitecan as a treatment option for patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma (DTC) or anaplastic thyroid carcinoma (ATC). This phase II, single-arm, non-randomized study aims to assess the effectiveness and safety of sacituzumab govitecan, which targets TROP-2, a protein highly expressed in these thyroid cancers. The study will include patients who have progressed after prior treatments or are in first-line settings for ATC. Participants will receive sacituzumab govitecan at a dose of 10 mg/kg given intravenously on Days 1 and 8 of a 21-day treatment cycle. Treatment will continue until disease progression, death, unacceptable toxicity, or withdrawal from the study. The study consists of two cohorts: one with patients having advanced DTC who have progressed after previous tyrosine kinase inhibitors, and another with patients having advanced or metastatic ATC receiving first-line or subsequent treatments. Dosing adjustments may be made based on patient weight and tolerability. During the study, patients will undergo tumor assessments using CT or MRI scans and blood tests for tumor markers every 12 weeks until disease progression or withdrawal. Researchers will measure outcomes such as objective response rate, disease control, duration of response, progression-free survival, overall survival, safety, and quality of life over approximately 42 months. The study design includes careful monitoring of treatment effects and patient well-being throughout participation.
CONDITIONS
Brief Title
Sacituzumab govitEcan in THYroid Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent approved by the ethics committee
- Be 18 years of age or older
- Have confirmed metastatic or locally advanced unresectable radioactive-iodine refractory differentiated thyroid cancer or anaplastic thyroid carcinoma
- For differentiated thyroid cancer, have progressed after at least one prior systemic therapy (up to 3 previous treatments)
- For anaplastic thyroid carcinoma, be in first-line treatment or after failure of up to one prior systemic therapy
- Have measurable metastatic or locally advanced disease documented by imaging
- Provide an archival tumor tissue sample or new biopsy for translational studies
- Have an ECOG performance status of 0 or 1
- Meet specific baseline laboratory values including neutrophil count, platelet count, hemoglobin, liver function, kidney function, and albumin levels
- Female participants must be non-childbearing or agree to use effective contraception and avoid pregnancy and breastfeeding during and for 6 months after treatment
- Male participants must agree to avoid sperm donation and use effective contraception if their partner can bear children
- Not participate in another interventional study during treatment
You will not qualify if you...
- Have central nervous system metastases
- Have ongoing significant toxicity from prior treatments (Grade 2 or higher except alopecia)
- Have another malignancy within 3 years except certain treated cancers
- Have active hepatitis B, hepatitis C, or HIV infection
- Have cardiac conditions such as recent myocardial infarction, serious arrhythmias, or severe heart failure
- Have moderate to severe chronic respiratory illness
- Have active chronic inflammatory bowel disease or recent gastrointestinal obstruction or perforation
- Have uncontrolled hypertension or diabetes
- Have had radiotherapy or major surgery within 4 weeks before treatment
- Have received live vaccines within 30 days or antibiotics within 1 week before treatment
- Have had chemotherapy, biologics, investigational agents, or immunotherapy within 2 weeks before treatment
- Have previously received topoisomerase 1 inhibitors
- Have known hypersensitivity to sacituzumab govitecan or its components
- Have other medical conditions that may impair ability to receive or tolerate treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until progression, death, withdrawal, or unacceptable toxicity
Participants receive sacituzumab govitecan intravenously on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, death, withdrawal, or unacceptable toxicity.
Infusions on Days 1 and 8 of each 21-day cycle
Duration - Up to approximately 42 months from first treatment
Participants undergo periodic tumor assessments by CT or MRI and blood monitoring every 12 weeks from the start of treatment until progression or withdrawal.
Tumor and blood assessments every 12 weeks
Trial Site Locations
Total: 11 locations
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
2
Complexo Hospitalario Universitario de Ferrol
Ferrol, Spain
Not Yet Recruiting
3
Institut Catala d´Oncologia (ICO) -Hospitalet
Hospitalet de Llobregat (Barcelona), Spain
Actively Recruiting
4
Hospital Clínico San Carlos
Madrid, Spain
Actively Recruiting
5
Hospital Universitario la Paz
Madrid, Spain
Actively Recruiting
6
Hospital Universitario Ramón y Cajal
Madrid, Spain
Not Yet Recruiting
7
MD Anderson Cancer Center Madrid
Madrid, Spain
Actively Recruiting
8
Hospital General Universitario Morales Meseguer
Murcia, Spain
Actively Recruiting
9
Hospital Universitario Central de Asturias
Oviedo, Spain
Actively Recruiting
10
H.U. Marqués de Valdecilla
Santander, Spain
Actively Recruiting
11
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
Research Team
A
A responsible person Designated by the Sponsor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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