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出境医 / 临床实验 / Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0

Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0

Study Description
Brief 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 (serum) sampling.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Sacituzumab Govitecan Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : July 10, 2021
Estimated Study Completion Date : July 10, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Breast Brain Metastasis and Glioblastoma
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.
 Drug: Sacituzumab Govitecan
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
Outcome Measures
Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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:

    • 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.
Contacts and Locations

Contacts
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Contact: Epp Goodwin 210-450-5798 ctrcreferral@uthscsa.edu

Locations
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United States, Texas
Mays Cancer Center, UT Health San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Epp Goodwin    210-450-1000      
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Gilead Sciences
Investigators
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Principal Investigator: Andrew Brenner, MD, PhD University of Texas Health at San Antonio
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date June 5, 2020
Actual Study Start Date  ICMJE July 17, 2019
Estimated Primary Completion Date July 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Level of Free SN-38 in the Cerebrospinal Fluid (CSF) [ Time Frame: Day 1 of each 21 day cycle. ]
    To determine the extent by which Sacituzumab Govitecan is able to penetrate the blood brain barrier by testing for free SN-38
  • Level of Free SN-38G in the Cerebrospinal Fluid (CSF) [ Time Frame: Day 1 of each 21 day cycle. ]
    To determine the extent by which Sacituzumab Govitecan is able to penetrate the blood brain barrier by testing for free SN-38G
  • Level of Total SN-38 in the Cerebrospinal Fluid (CSF) [ Time Frame: Day 1 of each 21 day cycle. ]
    To determine the extent by which Sacituzumab Govitecan is able to penetrate the blood brain barrier by testing for total SN-38
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Level of Free SN-38 in Tumor Tissue [ Time Frame: Day 1 of each 21 day cycle. ]
    To determine the extent by which Sacituzumab Govitecan is able to penetrate the tumor tissue by testing for free SN-38
  • Level of Free SN-38G in Tumor Tissue [ Time Frame: Day 1 of each 21 day cycle. ]
    To determine the extent by which Sacituzumab Govitecan is able to penetrate the tumor tissue by testing for free SN-38G
  • Level of Total SN-38 in Tumor Tissue [ Time Frame: Day 1 of each 21 day cycle. ]
    To determine the extent by which Sacituzumab Govitecan is able to penetrate the tumor tissue by testing for total SN-38
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0
Official Title  ICMJE A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma
Brief 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 (serum) sampling.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Drug: Sacituzumab Govitecan
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 Arms  ICMJE Experimental: Breast Brain Metastasis and Glioblastoma
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.
Intervention: Drug: Sacituzumab Govitecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 10, 2022
Estimated Primary Completion Date July 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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:

    • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Epp Goodwin 210-450-5798 ctrcreferral@uthscsa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995706
Other Study ID Numbers  ICMJE CTMS# 19-0069
HSC20190378H ( Other Identifier: UT Health Science Center Institutional Review Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Principal Investigator: Andrew Brenner, MD, PhD University of Texas Health at San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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