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Monoclonal Antibodies
Sacituzumab Govitecan for Brain Tumor
Phase < 1
Waitlist Available
Led By Andrew Brenner, MD, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent glioblastoma (Cohort B) with documented progression by RANO criteria following standard combined modality treatment with radiation and temozolomide
Adequate renal function: calculated creatinine clearance ≥30mL/minute according to the Cockcroft and Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of each 21 day cycle
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can shrink brain tumors before surgery. The drug will be given before surgery, and then during surgery, doctors will take out some of the tumor to test.
Who is the study for?
Adults with breast cancer that has spread to the brain or recurrent glioblastoma who are planning surgery as part of their care. They must be in fairly good health, have a life expectancy of at least 3 months, and agree to use effective contraception. Not eligible if they need emergency surgery, can't undergo MRI scans, take certain drugs like warfarin without switching, or have had specific treatments recently.Check my eligibility
What is being tested?
The trial is testing Sacituzumab Govitecan given before surgery for brain tumors from breast cancer or glioblastoma. It's a Phase 0 study where patients receive the drug preoperatively and then have tissue samples collected during their planned craniotomy.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions to anticancer medications such as nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk or bleeding problems. Specific side effects related to Sacituzumab Govitecan will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My glioblastoma has returned and worsened after standard treatment.
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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I have recovered from previous treatment side effects.
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My liver function tests are within the required range.
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My breast cancer has spread to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 of each 21 day cycle
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of each 21 day cycle
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ratio of SN-38 and its metabolites relative to serum concentration
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: Breast Brain Metastasis and GlioblastomaExperimental Treatment1 Intervention
Sacituzumab Govitecan treatment will be initiated with a 10mg/kg standard dose without any dose escalation on day-1, prior to surgery. Sacituzumab govitecan and will continue to be administered by IV infusion over 3 hours on Days 1 and 8 of a 21 day cycle post-operatively until progression.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,388 Total Patients Enrolled
4 Trials studying Glioblastoma
138 Patients Enrolled for Glioblastoma
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,815 Total Patients Enrolled
3 Trials studying Glioblastoma
553 Patients Enrolled for Glioblastoma
Andrew Brenner, MD, PhDPrincipal InvestigatorUniversity of Texas Health at San Antonio
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My glioblastoma has returned and worsened after standard treatment.My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.I am 18 years old or older.You are expected to live for at least 3 more months.I haven't taken seizure medications like carbamazepine or phenytoin in the last 14 days.I can take care of myself but might not be able to do heavy physical work.You have a heart condition that shows up on an ECG test, including a long QT interval or risk factors for a specific type of heart rhythm problem.I have had a recent brain bleed or tumor bleed, confirmed by MRI or CT scan.I do not have serious heart disease or recent heart attacks.I have recovered from previous treatment side effects.You need to have a certain level of white blood cells, platelets, and hemoglobin in your blood.My liver function tests are within the required range.I haven't taken any cancer treatment drugs or had Sacituzumab Govitecan in the last 21 days.My breast cancer has spread to my brain.I am scheduled for a craniotomy as part of my treatment plan.My only cancerous lesion was treated with targeted radiation in the last 3 months.I am on warfarin or similar blood thinners and cannot switch to LMWH before starting the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Breast Brain Metastasis and Glioblastoma
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.
What is the total enrollment figure for this trial?
"Affirmative. Clinicaltrials.gov has verified that this clinical trial is currently enrolling participants, with the first post being uploaded on July 17th 2019 and last modified on May 17th 2022. The research team must recruit 20 patients from one site for completion of the study."
Answered by AI
What is the typical purpose of administering Sacituzumab Govitecan?
"Sacituzumab Govitecan is the usual treatment for this medical intervention, but it has proven to be efficacious in treating other ailments such as pharmacotherapy, uc 84572, and breast."
Answered by AI
Is this medical research enrolling participants at the moment?
"This clinical trial, which was published on July 17th 2019 and last modified on May 17th 2022 according to the data found in clinicaltrials.gov, is currently looking for suitable candidates."
Answered by AI
Is this particular medical experiment a pioneering endeavor?
"Research into Sacituzumab Govitecan began in 2018, with the initial clinical trial sponsored by Hoffmann-La Roche. After successful completion of Phase 1 & 2 trials involving 435 participants, 33 active studies are now being conducted around the world in 418 cities across 32 nations."
Answered by AI
Are there any other investigations into the efficacy of Sacituzumab Govitecan?
"Presently, the research into Sacituzumab Govitecan comprises 33 active clinical trials. Of these studies, 5 are within Phase 3. Most of them take place in Birmigham and Massachusetts; however, there is a grand total of 1398 sites running investigations for this therapeutic remedy."
Answered by AI
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