A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed advanced or metastatic solid tumor that is measurable or nonmeasurable.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
• Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥1,500/mm\^3, and platelets ≥ 100,000/ μL).
• Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation.
• Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase (AST) ≤ 3.0× ULN).
• Moderate hepatic impairment (1.5 × ULN \< total bilirubin ≤ 3.0 × ULN and any level of AST).
• For individuals with hepatic encephalopathy, the condition does not, in the Investigator's opinion, interfere with the individual's ability to provide an appropriate informed consent.
Locations
United States
California
Pacific Shores Medical Group
SUSPENDED
Long Beach
Delaware
Christiana Care Health Services
RECRUITING
Newark
Maryland
University of Maryland
RECRUITING
Baltimore
Texas
NEXT Austin
WITHDRAWN
Austin
Oncology Consultants, P.A.
RECRUITING
Houston
The University of Texas M.D. Anderson Cancer Center
RECRUITING
Houston
NEXT Oncology
RECRUITING
San Antonio
Texas Liver Institute
RECRUITING
San Antonio
Other Locations
France
Institut Bergonie Medical Oncology
RECRUITING
Bordeaux
Centre Leon Berard
RECRUITING
Lyon
Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain
RECRUITING
Saint-herblain
Spain
Institut Català d'Oncologia - L'Hospitalet de Llobregat
RECRUITING
Barcelona
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date:2021-04-06
Estimated Completion Date:2026-12
Participants
Target number of participants:30
Treatments
Experimental: Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Participants with advanced solid tumor and moderate hepatic impairment will receive an escalating dose of sacituzumab govitecan-hziy on Days 1 and 8. The dose-escalation plan will start at 5 mg/kg and escalate to 7.5 mg/kg, and finally 10 mg/kg, if deemed to be safe. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).
Experimental: Advanced or Metastatic Solid Tumor and Normal Liver function
Participants with advanced or metastatic solid tumor and normal hepatic function will receive sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).