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

Conditions

• Gland
• Salivary Gland Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab Govitecan — DRUG
  Given by IV (vein)

Study Details

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

Key Dates

Start date

Jul 27, 2023

Status verified

Mar 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: ACC
  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.
• Experimental: Cohort 2: Non-ACC
  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.

Primary Outcome Measure

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 ]

Central Contacts

• Renata Ferrarotto, MD
  (713) 745-6774
  [email protected]

Locations (1)

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