Gland, Salivary Gland Cancers
Conditions
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 secretory gland carcinomas, specifically ACC (cohort 1) and SDC, adeno-NOS, and MEC (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
Interventions
DRUGSacituzumab Govitecan
Given by IV (vein)
Sponsors
M.D. Anderson Cancer Center
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Patients ≥18 years with histology-proven R/M salivary gland cancer. 2. Not amenable to curative intent surgery or radiotherapy 3. Measurable disease per RECIST 1.1 4. Performance status ECOG of 0 or 1 5. Patient has provided informed consent. 6. Laboratory measurements, blood counts: 1. Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria 2. Absolute neutrophil count ≥ 1 x 10\^9/mL without growth factor support for 28 days 3. Platelets ≥ 100 x 10\^9/mL without platelet transfusion for 28 days 7. Laboratory measurements, renal function: Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation 8. Laboratory measurements, hepatic function: 1. AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases 2. 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 9. 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). 10. 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: 11. 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. 12. Disease progression per RECIST within 6 months or unequivocal clinical progression within 6 months per investigator's assessment. 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: 13. 13\) Patients with histology-proven R/M SDC or intermediate or high-grade adenocarcinoma NOS, or intermediate or high grade MEC, who progressed on up to 3 lines of palliative chemotherapy in the R/M setting. Any number of prior targeted-therapy, hormonal therapy, and/or immunotherapy are allowed. 14. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | through study completion; an average of 2 years |
Countries
United States
Contacts
CONTACTRenata Ferrarotto, MD
PRINCIPAL_INVESTIGATORRenata Ferrarotto, MD
M.D. Anderson Cancer Center
Outcome results
None listed