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Monoclonal Antibodies
Sacituzumab for Thymoma
Phase 2
Recruiting
Led By Chul Kim, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial aims to see how sacituzumab govitecan-hziy affects adult patients with advanced thymoma and thymic carcinoma who have not responded to previous treatments. Patients will
Who is the study for?
This trial is for adults with advanced thymoma or thymic carcinoma who have already tried at least one treatment without success. Participants will receive ongoing cycles of a drug called Sacituzumab Govitecan, given through the vein once weekly on specific days, and will be monitored regularly.Check my eligibility
What is being tested?
The trial tests Sacituzumab Govitecan's effectiveness in treating advanced thymoma and thymic carcinoma. The key measure is the overall response rate to this medication after previous treatments failed. Patients get fixed doses over continuous 21-day cycles until they can't tolerate it or their disease gets worse.See study design
What are the potential side effects?
Potential side effects of Sacituzumab Govitecan include nausea, fatigue, hair loss, decreased blood cell counts leading to higher infection risk or bleeding problems, diarrhea, and allergic reactions during infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to either not have sex or use birth control, and not to donate sperm.
Select...
My hepatitis B is under control or I'm on treatment, and if I had hepatitis C, it's been treated.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with advanced thymoma or thymic carcinoma.
Select...
My blood and organ tests meet the required health standards.
Select...
My condition worsened after at least one treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Overall survival (OS)
Progression-free survival (PFS)
Side effects data
From 2020 Phase 3 trial • 529 Patients • NCT0257445540%
Fatigue
30%
Nausea
27%
Anaemia
25%
Neutropenia
23%
Constipation
21%
Decreased appetite
20%
Neutrophil count decreased
18%
Cough
18%
Dyspnoea
17%
Diarrhoea
16%
Alopecia
16%
Vomiting
13%
Hypokalaemia
13%
Headache
13%
Back pain
13%
Asthenia
12%
Pyrexia
12%
Aspartate aminotransferase increased
11%
Oedema peripheral
11%
Neuropathy peripheral
10%
Alanine aminotransferase increased
10%
White blood cell count decreased
8%
Urinary tract infection
8%
Myalgia
8%
Pain in extremity
7%
Platelet count decreased
7%
Arthralgia
7%
Dizziness
7%
Abdominal pain
7%
Weight decreased
6%
Mucosal inflammation
6%
Lymphocyte count decreased
6%
Bone pain
6%
Hypomagnesaemia
6%
Hypertension
6%
Thrombocytopenia
6%
Stomatitis
5%
Insomnia
5%
Pain
5%
Rash
5%
Blood alkaline phosphatase increased
5%
Hyperglycaemia
4%
Oropharyngeal pain
4%
Hypophosphataemia
4%
Anxiety
4%
Abdominal pain upper
4%
Breast pain
3%
Upper respiratory tract infection
3%
Musculoskeletal chest pain
3%
Dysgeusia
3%
Lymphoedema
3%
Pruritus
3%
Pleural effusion
3%
Gastrooesophageal reflux disease
3%
Chills
2%
Nasopharyngitis
2%
Hypocalcaemia
2%
Febrile neutropenia
2%
Sepsis
2%
Pneumonia
1%
Nasal congestion
1%
Dyspnoea exertional
1%
Dry skin
1%
Rash maculo-papular
1%
Pericardial effusion
1%
Pulmonary embolism
1%
Respiratory failure
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment of Physician's Choice (TPC)
Sacituzumab Govitecan
Trial Design
1Treatment groups
Experimental Treatment
Group I: SacituzumabExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,484 Total Patients Enrolled
2 Trials studying Thymoma
53 Patients Enrolled for Thymoma
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,244 Total Patients Enrolled
Chul Kim, MDPrincipal InvestigatorChul.Kim@gunet.georgetown.edu
4 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Thymoma
8 Patients Enrolled for Thymoma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently enrolling participants for this study?
"As per the details on clinicaltrials.gov, recruitment for this particular study has concluded. The trial was initially listed on 1st July 2024 and last modified on 31st January 2024. However, there are currently an active total of 2529 other trials open for enrollment at this time."
Answered by AI
Has Sacituzumab received official approval from the FDA?
"Based on our evaluation at Power, the safety rating for Sacituzumab is 2 due to being in a Phase 2 trial where there's existing safety data but no evidence of efficacy yet."
Answered by AI
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