Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers
M.D. Anderson Cancer Center
Summary
To learn if sacituzumab govitecan can help to control salivary gland cancer.
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 facto…
Interventions
- DrugSacituzumab Govitecan
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas