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Alkylating agents
Sacituzumab + Cisplatin for Ovarian and Uterine Cancer
Phase 1 & 2
Recruiting
Led By Amy Tiersten, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ function: Total bilirubin ≤ 1.5 ULN, AST(SGOT)/ALT(SPGT) ≤ 2.5x ULN or ≤ 5 x ULN if known liver metastases, Serum albumin > 3 g/dL, Creatinine clearance ≥ 50 mL/min per the Cockcroft-Gault equation
Patient has measurable disease (at least one lesion that can be accurately assessed repeatedly by CT) as evidenced on pre-treatment baseline CT of Chest/Abdomen/Pelvis or PET/CT, or evaluable disease
Must not have
Treatment with any other chemotherapy, immunotherapy or anticancer agents within 14 days of the first dose of study treatment
Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the best dose of a drug combo to treat ovarian and endometrial cancers.
Who is the study for?
This trial is for women aged 18+ with recurrent ovarian or endometrial cancer that's sensitive to platinum-based chemo, showing progression more than 6 months after the last dose. Participants must have a WHO performance status of 0-1 and measurable disease. They should not have severe diseases, be pregnant/nursing, or have had certain treatments recently.
What is being tested?
The study tests Sacituzumab Govitecan combined with Cisplatin in patients with specific types of ovarian and endometrial cancers. It aims to find the best dose for this combination therapy in an open-label, Phase 1 trial setting.
What are the potential side effects?
Potential side effects may include reactions similar to those from chemotherapy such as nausea, fatigue, blood count changes; allergic reactions; organ inflammation; and possibly others related to Sacituzumab Govitecan which will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one cancer lesion that can be measured on a CT scan.
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My cancer is confirmed to be ovarian or endometrial.
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My blood counts meet the required levels for treatment.
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I am a woman aged 18 or older.
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I am mostly active and my health hasn't worsened in the last 2 weeks. I am expected to live at least 12 more weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken any cancer treatments in the last 14 days.
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I have not had major surgery in the last 4 weeks.
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I don't have severe side effects from previous treatments.
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I do not have severe illnesses or uncontrolled infections like hepatitis or HIV.
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I am allergic to drugs similar to sacituzumab govitecan, cisplatin, or irinotecan.
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I have ongoing nausea or vomiting and chronic stomach issues.
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I have had serious heart issues like a heart attack or unstable chest pain in the last 6 months.
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I have moderate to severe nerve damage.
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I haven't had serious bleeding, blockage in my intestines, or a hole in my gut in the last 6 months.
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I have never been treated with sacituzumab govitecan, irinotecan, or similar drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose limiting toxicity (DLT) for the DEC Phase
Dose-limiting toxicity (DLT) at the maximum tolerated dose (MTD) for the Safety Run-In Phase
Overall Response Rate (ORR)
Secondary study objectives
Clinical Benefit Response (CBR)
Number of adverse events
Progression free survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Ovarian cancer CohortExperimental Treatment2 Interventions
DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin
Group II: Endometrial cancer CohortExperimental Treatment2 Interventions
DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
913 Previous Clinical Trials
572,747 Total Patients Enrolled
2 Trials studying Ovarian Cancer
21,148 Patients Enrolled for Ovarian Cancer
Amy Tiersten, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology
8 Previous Clinical Trials
255 Total Patients Enrolled