Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

Launched by GILEAD SCIENCES · Nov 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called sacituzumab govitecan-hziy for people with advanced or metastatic solid tumors who also have moderate liver problems. The main goals are to find out how safe the drug is and how much of it should be given to patients with these conditions. The trial is currently looking for participants aged 65 to 74, and both men and women can join.

To be eligible for the study, participants need to have a confirmed diagnosis of advanced or metastatic solid tumors. They should also have good overall health, meaning they can perform normal daily activities with minimal assistance. Additionally, their liver function should be somewhat impaired but not severely, and other health criteria must be met. If you join the study, you can expect regular check-ups and monitoring to ensure your safety while receiving the study medication. It's important to note that certain health conditions and recent treatments may prevent some people from participating. If you're considering this trial, it's a good idea to discuss it with your healthcare provider to see if it's right for you.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria for all Individuals:
• • 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.
• Key Exclusion Criteria for all Individuals:
• • 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 1) 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 (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 known 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 significant clinical exacerbation of liver disease symptoms 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.