RecruitingPhase 2

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

United States30 participantsStarted 2023-07-27

Plain-language summary

To learn if sacituzumab govitecan can help to control salivary gland cancer.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 10\^9/mL without growth factor support for 28 days

✕. 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

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Timeframe: through study completion; an average of 2 years

NCT IDNCT05884320

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-31

Renata Ferrarotto, MD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 10\^9/mL without growth factor support for 28 days

✕. 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