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Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Salivary Gland Cancers

Primary Purpose

Gland, Salivary Gland Cancers

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sacituzumab Govitecan
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gland

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients must meet all of the following inclusion criteria to be eligible for participation in this study: Patients ≥18 years with histology-proven R/M salivary gland cancer. Not amenable to curative intent surgery or radiotherapy Measurable disease per RECIST 1.1 Performance status ECOG of 0 or 1 Patient has provided informed consent. Laboratory measurements, blood counts: Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria Absolute neutrophil count ≥ 1 x 109/mL without growth factor support for 28 days Platelets ≥ 100 x 109/mL without platelet transfusion for 28 days Laboratory measurements, renal function: Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation Laboratory measurements, hepatic function: AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN and primarily unconjugated if patient has a documented history of Gilbert's syndrome or genetic equivalent Female patients with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study therapy. The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent (including oral, subcutaneous, intrauterine, or intramuscular agents). Male patients who are sexually active with women with reproductive potential must agree to use contraception for the duration of treatment and for at least 90 days after completion of study therapy. Cohort 1: In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Cohort 1 must fulfill the following cohort-specific inclusion criteria: Patients with histology-proven R/M ACC who are treatment-naïve or received any number of prior systemic therapy in the setting of R/M disease. Disease progression per RECIST within 6 months. Cohort 2: In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Cohort 2 must fulfill the following cohort-specific inclusion criterion: Patients with histology-proven R/M SDC or adenocarcinoma NOS who progressed on up to 3 lines of palliative systemic therapy in the R/M setting. Patients with HER2 overexpressing (3+ by IHC) or amplified tumors, must have received at least one prior line with a HER2-targeting agent OR must have a contra-indication for HER-2 targeted therapy (Eg: reduced left ventricular ejection fraction). Exclusion Criteria: Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study: Prior radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment Active CNS disease (patients with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active) Red blood cell transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. Red blood cell transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criterion. Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives prior to SG treatment Current participation in another interventional clinical study History of previous malignancy other than malignancy treated with curative intent. Patients with the following diagnoses represents an exception and may enroll if ≥ 1 year with no evidence of active disease before the first dose of the study drug.: Non-melanoma skin cancers with no current evidence of disease Melanoma in situ with no current evidence of disease Localized cancer of the prostate with prostate-specific antigen of <1 ng/mL Treated or localized well-differentiated thyroid cancer Treated cervical carcinoma in situ Treated ductal/lobular carcinoma in situ of the breast Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 10 days prior to administration of investigational product. Patients with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study provided the viral load is undetectable at screening. Disease or medical conditions that would substantially increase the risk-benefit ratio of participating in the study that include: acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV Female patients who are pregnant or breast-feeding Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. High dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of study treatment (C1D1). Cognitively impaired patients who are incompetent to consent.

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1: ACC

Cohort 2: Non-ACC

Arm Description

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.

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.

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 22, 2023
Last Updated
September 21, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05884320
Brief Title
Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Salivary Gland Cancers
Official Title
Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Salivary Gland Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To learn if sacituzumab govitecan can help to control salivary gland cancer.
Detailed Description
Primary Objectives: To assess the efficacy of SG in patients with R/M salivary gland carcinoma, specifically ACC (cohort 1) and SDC and adeno-NOS (cohort 2) Secondary Objectives: To estimate the median duration of response (DOR) To estimate the median progression-free survival (PFS) To estimate the median overall survival (OS) To assess safety of SG Tertiary / Exploratory Objectives: To explore biomarkers that may predict response to therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gland, Salivary Gland Cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: ACC
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2: Non-ACC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sacituzumab Govitecan
Intervention Description
Given by IV (vein)
Primary Outcome Measure Information:
Title
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time Frame
through study completion; an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must meet all of the following inclusion criteria to be eligible for participation in this study: Patients ≥18 years with histology-proven R/M salivary gland cancer. Not amenable to curative intent surgery or radiotherapy Measurable disease per RECIST 1.1 Performance status ECOG of 0 or 1 Patient has provided informed consent. Laboratory measurements, blood counts: Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria Absolute neutrophil count ≥ 1 x 109/mL without growth factor support for 28 days Platelets ≥ 100 x 109/mL without platelet transfusion for 28 days Laboratory measurements, renal function: Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation Laboratory measurements, hepatic function: AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN and primarily unconjugated if patient has a documented history of Gilbert's syndrome or genetic equivalent Female patients with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study therapy. The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent (including oral, subcutaneous, intrauterine, or intramuscular agents). Male patients who are sexually active with women with reproductive potential must agree to use contraception for the duration of treatment and for at least 90 days after completion of study therapy. Cohort 1: In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Cohort 1 must fulfill the following cohort-specific inclusion criteria: Patients with histology-proven R/M ACC who are treatment-naïve or received any number of prior systemic therapy in the setting of R/M disease. Disease progression per RECIST within 6 months. Cohort 2: In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Cohort 2 must fulfill the following cohort-specific inclusion criterion: Patients with histology-proven R/M SDC or adenocarcinoma NOS who progressed on up to 3 lines of palliative systemic therapy in the R/M setting. Patients with HER2 overexpressing (3+ by IHC) or amplified tumors, must have received at least one prior line with a HER2-targeting agent OR must have a contra-indication for HER-2 targeted therapy (Eg: reduced left ventricular ejection fraction). Exclusion Criteria: Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study: Prior radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment Active CNS disease (patients with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active) Red blood cell transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. Red blood cell transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criterion. Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives prior to SG treatment Current participation in another interventional clinical study History of previous malignancy other than malignancy treated with curative intent. Patients with the following diagnoses represents an exception and may enroll if ≥ 1 year with no evidence of active disease before the first dose of the study drug.: Non-melanoma skin cancers with no current evidence of disease Melanoma in situ with no current evidence of disease Localized cancer of the prostate with prostate-specific antigen of <1 ng/mL Treated or localized well-differentiated thyroid cancer Treated cervical carcinoma in situ Treated ductal/lobular carcinoma in situ of the breast Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 10 days prior to administration of investigational product. Patients with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study provided the viral load is undetectable at screening. Disease or medical conditions that would substantially increase the risk-benefit ratio of participating in the study that include: acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV Female patients who are pregnant or breast-feeding Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. High dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of study treatment (C1D1). Cognitively impaired patients who are incompetent to consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renata Ferrarotto, MD
Phone
(713) 745-6774
Email
rferrarotto@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Ferrarotto, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Ferrarotto, MD
Phone
713-745-6774
Email
rferrarotto@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Renata Ferrarotto, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Salivary Gland Cancers

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