GlioblastomaEarly Phase 1NCT03995706
Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0
A Early Phase 1 study testing Sacituzumab Govitecan in people with Glioblastoma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Single center, non-randomized, Phase 0 study. Sacituzumab Govitecan given preoperatively, followed by craniotomy with surgery or biopsy of brain tumors (GBM and metastatic brain tumors from Breast) and intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Sacituzumab Govitecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2019to 20 Mar 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Histologically or cytologically documented breast cancer (Cohort A) with known or suspected parenchymal brain metastases.
- Recurrent glioblastoma (Cohort B) with documented progression by RANO criteria following standard combined modality treatment with radiation and temozolomide.
- Plans to undergo craniotomy as part of standard of care. Patients emergently needing surgical debulking due to symptoms of their disease are not eligible.
- Recovered from toxicities of prior therapy to grade 0 or 1
- ECOG performance status ≤ 2.
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- Life expectancy of at least 3 months.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN);
- Adequate renal function: calculated creatinine clearance ≥30mL/minute according to the Cockcroft and Gault formula
- Acceptable hematologic status (without hematologic support)
- ANC ≥1500 cells/uL
- Platelet count ≥100,000/uL
- Hemoglobin ≥9.0 g/dL
- All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.
Who cannot join
- The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
- The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
- The subject is unable to undergo MRI scan (eg, has pacemaker).
- The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
- Patients whose only lesion undergoing resection has received stereotactic radiation within the past 3 months
- The subject has received any of the following prior anticancer therapy:
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- Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
- Prior treatment with Sacituzumab Govitecan
- Patients receiving UGT1A1 (Uridine diphosphate glucuronosyl transferase 1A1) inhibitors or inducers.
- History of significant cardiovascular disease, defined as:
- Congestive heart failure greater than New York Heart Association (NYHA) Class II according to the NYHA Functional Classification.
- Unstable angina or myocardial infarction within 6 months before enrollment.
- Serious cardiac arrhythmia.
- Clinically significant ECG abnormality, including:
- Marked Baseline prolonged QT/QTc interval (ie, a repeated demonstration of a QTc interval >500 ms) demonstrated on ECG at Screening.
- History of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome).
- Any medical or other condition which, in the opinion of the Investigator, causes the subject to be medically unfit to receive Sacituzumab Govitecan, or unsuitable for any other reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma
Single center, non-randomized, Phase 0 study. Sacituzumab Govitecan given preoperatively, followed by craniotomy with surgery or biopsy of brain tumors (GBM and metastatic brain tumors from Breast) and intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling.
- Conditions
- Glioblastoma
- Being tested
- Sacituzumab Govitecan
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab GovitecanDrug
All 20 subjects will receive study drug Sacituzumab Govitecan preoperatively. Intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling. Samples will be tested for total SN-38and free SN-38, as well as SN-38G. Following recovery from surgery, patients will resume treatment
| Study group | Role | What they receive |
|---|---|---|
| Breast Brain Metastasis and Glioblastoma | Experimental | 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. Receives: Drug: Sacituzumab Govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of SN-38 and its metabolites relative to serum concentration
Levels of SN-38 and its metabolites will be measured and a ratio calculated relative to the serum concentration of SN-38 and its metabolites. The ratio will show the amount of investigational product that crosses the blood brain barrier to reach the tumor.
Measured: Day 1 of each 21 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start17 Jul 2019
- Primary completion3 Jun 2022
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Andrew Brenner, MD, PhD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995706
- Sponsor's protocol ID
- CTMS# 19-0069
- Other IDs
- HSC20190378H
- Status last verified
- Aug 2024
- First submitted
- 17 Jun 2019
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Balinda HU, Kelly WJ, Kaklamani VG, Lathrop KI, Canola MM, Ghamasaee P, Sareddy GR, Michalek J, Gilbert AR, Surapaneni P, Tiziani S, Pandey R, Chiou J, Lodi A, Floyd JR 2nd, Brenner AJ. Sacituzumab Govitecan in patients with breast cancer brain metastases and recurrent glioblastoma: a phase 0 window-of-opportunity trial. Nat Commun. 2024 Aug 7;15(1):6707. doi: 10.1038/s41467-024-50558-9.
PubMed 39112464
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma
- ClinicalTrials.gov ID
- NCT03995706
- Acronym / sponsor ID
- CTMS# 19-0069
- Conditions
- Glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single center, non-randomized, Phase 0 study. Sacituzumab Govitecan given preoperatively, followed by craniotomy with surgery or biopsy of brain tumors (GBM and metastatic brain tumors from Breast) and intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Brain Metastasis and Glioblastoma | Experimental | Drug: Sacituzumab GovitecanSacituzumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At least 18 years of age
- Histologically or cytologically documented breast cancer (Cohort A) with known or suspected parenchymal brain metastases.
- Recurrent glioblastoma (Cohort B) with documented progression by RANO criteria following standard combined modality treatment with radiation and temozolomide.
- Plans to undergo craniotomy as part of standard of care. Patients emergently needing surgical debulking due to symptoms of their disease are not eligible.
- Recovered from toxicities of prior therapy to grade 0 or 1
Key exclusion criteria (17 listed)
- The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
- The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
- The subject is unable to undergo MRI scan (eg, has pacemaker).
- The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
- Patients whose only lesion undergoing resection has received stereotactic radiation within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab GovitecanAll 20 subjects will receive study drug Sacituzumab Govitecan preoperatively. Intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling. Samples will be tested for total SN-38and free SN-38, as well as SN-38G. Following recovery from surgery, patients will resume treatment | Drug | Breast Brain Metastasis and Glioblastoma |
Primary outcome
Ratio of SN-38 and its metabolites relative to serum concentration
Time frame: Day 1 of each 21 day cycle
Levels of SN-38 and its metabolites will be measured and a ratio calculated relative to the serum concentration of SN-38 and its metabolites. The ratio will show the amount of investigational product that crosses the blood brain barrier to reach the tumor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Derived from this study: PubMed 39112464Balinda HU, Kelly WJ, Kaklamani VG, Lathrop KI, Canola MM, Ghamasaee P, Sareddy GR, Michalek J, Gilbert AR, Surapaneni P, Tiziani S, Pandey R, Chiou J, Lodi A, Floyd JR 2nd, Brenner AJ. Sacituzumab Govitecan in patients with breast cancer brain metastases and recurrent glioblastoma: a phase 0 window-of-opportunity trial. Nat Commun. 2024 Aug 7;15(1):6707. doi: 10.1038/s41467-024-50558-9.
- Open Access publication of resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Brenner, MD, PhD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sacituzumab Govitecan in people with Glioblastoma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of SN-38 and its metabolites relative to serum concentration (time frame: Day 1 of each 21 day cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.