RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-07-27

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05884320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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: 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.	1. Prior radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment 2. 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) 3. 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. 4. Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives prior to SG treatment 5. Current participation in another interventional clinical study 6. 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.: 1. Non-melanoma skin cancers with no current evidence of disease 2. Melanoma in situ with no current evidence of disease 3. Localized cancer of the prostate with prostate-specific antigen of \<1 ng/mL 4. Treated or localized well-differentiated thyroid cancer 5. Treated cervical carcinoma in situ 6. Treated ductal/lobular carcinoma in situ of the breast 7. 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. 8. 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 9. Female patients who are pregnant or breast-feeding 10. Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient 11. Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. 12. High dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of study treatment (C1D1). 13. Cognitively impaired patients who are incompetent to consent.

Inclusion Criteria

Exclusion Criteria

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:
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.

1. Prior radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment
2. 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)
3. 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.
4. Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives prior to SG treatment
5. Current participation in another interventional clinical study
6. 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.:
1. Non-melanoma skin cancers with no current evidence of disease
2. Melanoma in situ with no current evidence of disease
3. Localized cancer of the prostate with prostate-specific antigen of \<1 ng/mL
4. Treated or localized well-differentiated thyroid cancer
5. Treated cervical carcinoma in situ
6. Treated ductal/lobular carcinoma in situ of the breast
7. 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.
8. 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
9. Female patients who are pregnant or breast-feeding
10. Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient
11. Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
12. High dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of study treatment (C1D1).
13. Cognitively impaired patients who are incompetent to consent.

Contacts and Locations

Study Contact

Renata Ferrarotto, MD

CONTACT

(713) 745-6774

rferrarotto@mdanderson.org

Principal Investigator

Renata Ferrarotto, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Renata Ferrarotto, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-27

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-07-27

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Gland
Salivary Gland Cancers