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Monoclonal Antibodies
Sacituzumab Govitecan for Glioblastoma
Phase 2
Recruiting
Led By Andrew Brenner, MD
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
Recovered from toxicities of prior therapy to grade 0 or 1, except for neuropathy (≤Grade 2) and alopecia.
Histologically confirmed IDH wild-type (de novo) GBM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test an experimental drug on patients with no other options.
Who is the study for?
Adults with confirmed IDH wild-type glioblastoma that has progressed after standard treatment, including radiation and chemotherapy. Participants must have stable vital signs, acceptable blood counts, liver and kidney function, agree to use contraception, and not be pregnant or breastfeeding. They should not have had certain recent treatments or surgeries and must be willing to stop using tumor treatment field therapy.Check my eligibility
What is being tested?
The trial is testing Sacituzumab Govitecan as a single agent in an open-label setting for recurrent glioblastoma patients. Everyone in the study will receive this investigational drug to evaluate its effectiveness against this type of brain cancer.See study design
What are the potential side effects?
While specific side effects for Sacituzumab Govitecan are not listed here, common ones may include nausea, fatigue, hair loss (alopecia), low blood cell counts leading to increased infection risk or bleeding problems. Organ-specific inflammation could also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have recovered from previous treatment side effects, except for mild neuropathy or hair loss.
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My glioblastoma is confirmed to be IDH wild-type.
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My liver function tests are within the required range.
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I am 18 years old or older.
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My kidneys work well enough (creatinine clearance ≥30 mL/min).
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I am willing to not use Optune therapy while in this study.
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I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
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: Sacituzumab govitecanExperimental Treatment1 Intervention
Dosing will be at 10 mg/kg on days 1 and 8 of a 21-day cycle
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
453 Previous Clinical Trials
91,390 Total Patients Enrolled
4 Trials studying Glioblastoma
124 Patients Enrolled for Glioblastoma
Andrew Brenner, MDPrincipal InvestigatorMays Cancer Center, UT Health San Antonio
3 Previous Clinical Trials
209 Total Patients Enrolled
1 Trials studying Glioblastoma
35 Patients Enrolled for Glioblastoma
William Kelly, MDPrincipal InvestigatorMays Cancer Center, UT Health San Antonio
1 Previous Clinical Trials
25 Total Patients Enrolled
1 Trials studying Glioblastoma
25 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious health condition like uncontrolled high blood pressure or heart issues.I am taking warfarin or similar drugs and cannot switch to LMWH before starting the study drug.I have recovered from previous treatment side effects, except for mild neuropathy or hair loss.I have had a recent brain bleed or tumor bleed, but it's getting better or was very small.I have taken epilepsy drugs like carbamazepine or phenytoin in the last 14 days.I have recovered from side effects of previous treatments, except for hair loss, low red blood cell, or low white blood cell counts.My biological samples are available for further testing.I understand the study's risks and have signed the consent form.My glioblastoma is confirmed to be IDH wild-type.My brain cancer progressed after standard treatment, and I haven't had other treatments.I had surgery for cancer recurrence at least 2 weeks ago and an MRI within 48 hours after.My liver function tests are within the required range.I am 18 years old or older.My kidneys work well enough (creatinine clearance ≥30 mL/min).I haven't had radiotherapy in the last 3 months before my cancer progressed.I am willing to not use Optune therapy while in this study.I can take care of myself but might not be able to do heavy physical work.My steroid dosage has been stable or decreasing for the last week.I have been treated with medications targeting blood vessel growth in cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab govitecan
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.
Has Sacituzumab Govitecan been endorsed by the FDA?
"There is an abundance of evidence to suggest Sacituzumab Govitecan's safety, thus earning a score of 2 on our 1-3 scale. However, since this drug is only in Phase 2 trials, the data supporting efficacy remains sparse."
Answered by AI
What is the size of the pool of participants for this clinical trial?
"Affirmative. Data recorded on clinicaltrials.gov confirms that this medical investigation, which was initially posted on January 6th 2022, is actively recruiting. Approximately 40 participants need to be enlisted from 3 different locations."
Answered by AI
Is there still room to join the experiment for interested participants?
"Clinicaltrials.gov shows that this clinical research is still in need of participants, with the original post date being January 6th 2022 and most recent edit occurring on February 16th."
Answered by AI
What other research efforts have been made involving Sacituzumab Govitecan?
"The initial trials for sacituzumab govitecan were conducted in 2018 at the Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley. There are now two completed experiments, with 33 active studies being performed primarily out of San Antonio, Texas."
Answered by AI
What primary indication is Sacituzumab Govitecan typically used to treat?
"Sacituzumab Govitecan is usually administered during a therapeutic procedure. However, it has proven effective at treating additional medical issues such as pharmacotherapy, uc 84572, and breast cancer."
Answered by AI
Have these findings been previously explored?
"At present, there are 33 different Sacituzumab Govitecan trials being conducted across 418 cities and 32 countries. The trail first began in 2018, sponsored by Hoffmann-La Roche with 435 participants. As of now, two studies have concluded since the initial launch date."
Answered by AI
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