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Monoclonal Antibodies
Sacituzumab Govitecan for Salivary Gland Cancer
Phase 2
Recruiting
Led By Renata Ferrarotto, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 2 years
Awards & highlights
Study Summary
This trial will test if a new drug can help control a rare form of cancer.
Who is the study for?
Adults with recurrent/metastatic salivary gland cancer, not suitable for surgery or radiotherapy. Must have good performance status (ECOG 0 or 1), adequate blood counts, liver and kidney function. Men and women must use effective contraception. Excludes those who've had recent cancer treatments, other active cancers (with some exceptions if disease-free for a year), known drug hypersensitivity, brain metastases, recent transfusions or therapies, ongoing serious infections, heart failure, pregnancy/breastfeeding.Check my eligibility
What is being tested?
The trial is testing Sacituzumab Govitecan to see if it can control salivary gland cancer better than current treatments. It's given to patients who may have tried other treatments without success or are treatment-naïve in certain cases. The study will monitor the effectiveness by measuring tumor size changes according to RECIST criteria.See study design
What are the potential side effects?
Sacituzumab Govitecan could cause side effects like nausea, fatigue, hair loss (alopecia), decreased white blood cell count which can lead to increased infection risk; diarrhea; and potential infusion-related reactions such as fever or chills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Non-ACCExperimental Treatment1 Intervention
Paritcipants will receive sacituzumab govitecan by vein on Days 1 and 8 of each cycle. The first dose will be given over about 3 hours. All other doses will be given over about 1-2 hours. Premedication for prevention of infusion reactions will be administered prior to each sacituzumab govitecan infusion.
Group II: Cohort 1: ACCExperimental Treatment1 Intervention
Paritcipants will receive sacituzumab govitecan by vein on Days 1 and 8 of each cycle. The first dose will be given over about 3 hours. All other doses will be given over about 1-2 hours. Premedication for prevention of infusion reactions will be administered prior to each sacituzumab govitecan infusion.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,316 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,449 Total Patients Enrolled
Renata Ferrarotto, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
129 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation or similar treatments in the last 2 weeks.My brain or spinal cord cancer is not currently active.I am 18 or older with confirmed recurrent/metastatic salivary gland cancer.I haven't had cancer treatment like chemo or immunotherapy in the last 4 weeks.I do not have an active infection or my viral infections like hepatitis B, C, or HIV are under control.I have ACC and it has gotten worse in the last 6 months, regardless of my treatment history.I haven't taken high doses of steroids in the last 2 weeks.I don't have recent heart issues, uncontrolled diabetes, serious infections, or severe heart failure.I am not pregnant or breastfeeding.I am unable to make my own medical decisions due to cognitive impairment.Surgery or radiotherapy cannot cure my condition.I agree to use contraception during and for 3 months after treatment.I am fully active or restricted in physically strenuous activity but can do light work.I have not received a live-virus vaccine in the last 30 days.I had cancer before, but it was treated and has been inactive for over a year.I've needed more than 2 blood transfusions in the last month.My hemoglobin level is at least 9 g/dL, possibly after a transfusion.I have specific cancer types and have had up to 3 chemotherapy treatments.I am using two effective birth control methods if I can get pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2: Non-ACC
- Group 2: Cohort 1: ACC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any open/available slots for this research study?
"Per clinicaltrials.gov, this specific trial is no longer recruiting participants and was last edited on May 22nd 2023. Nevertheless, there are 37 other trials that are actively searching for patients at the present time."
Answered by AI
What potential hazards do participants in Cohort 1: ACC face?
"Our analysts have assessed the safety of Cohort 1: ACC to be a 2, as there is some clinical evidence supporting its safety but no data indicating that it is efficacious."
Answered by AI
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