Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan-hziy in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

  • STATUS
    Recruiting
  • End date
    Dec 20, 2022
  • participants needed
    26
  • sponsor
    Gilead Sciences
Updated on 20 July 2022
body mass index
absolute neutrophil count
encephalopathy
hepatic impairment
moderate hepatic insufficiency

Summary

The primary objectives of this study are to identify the safe starting dose of sacituzumab govitecan-hziy, assess the number of participants with antibodies against sacituzumab govitecan-hziy, and evaluate the pharmacokinetics (PK) of sacituzumab govitecan-hziy, free SN-38, SN-38 glucuronide (SN-38G), total SN-38, in participants with solid tumor and moderate hepatic impairment.

Details
Condition Advanced or Metastatic Solid Tumor, Liver Failure
Treatment Sacituzumab govitecan, Sacituzumab Govitecan-hziy
Clinical Study IdentifierNCT04617522
SponsorGilead Sciences
Last Modified on20 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Key Inclusion Criteria for Individuals with Normal Hepatic Function
Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase [AST] ≤ 3.0× ULN)
Key Inclusion Criteria for Individuals with Moderate Hepatic Function
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

Exclusion Criteria

Have poor venous access
Donated or lost 500mL or more of blood volume (including plasmapheresis) to plans to donate during the study
Have had a prior anticancer biologic agent within 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 and who have not recovered (i.e., ≤ Grade 2) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible
Had prior treatment with irinotecan within 4 weeks prior to Day 1
Have not recovered (i.e., ≤ Grade 1) from AEs due to a previously administered agent
Have an active second malignancy
Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 20 mg/day of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability
Have history of cardiac disease
Have active chronic inflammatory bowel disease (ulcerative colitis or Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment
Have active serious infection requiring intravenous antibiotics (Contact medical monitor for clarification)
High-dose systemic corticosteroids (≥20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Check-In. However, inhaled, intranasal, intra-articular, and topical steroids are allowed
Use of strong inhibitor or inducer of UGT1A1
Have a history of Gilbert's disease
Key Exclusion Criteria for Individuals with Normal Hepatic Impairment
Must have pre-existing condition interfering with hepatic and/or renal function that could interfere with the metabolism and/or excretion of the study drug
Key Exclusion Criteria for Individuals with Moderate Hepatic Impairment
Had a clinical exacerbation of liver disease within the 2-week period before administration of study drug (i.e., abdominal pain, nausea, vomiting, anorexia, or fever)
Had clinically demonstrable, tense ascites
Had evidence of acute viral hepatitis within 1 month prior to administration of study drug
Have evidence of hepatorenal syndrome
Individuals with transjugular intrahepatic portosystemic shunt (TIPS) placement
Have active Stage 3 or 4 encephalopathy
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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