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Alkylating agents

Sacituzumab + Cisplatin for Ovarian and Uterine Cancer

Phase 1 & 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicity (DLT) for the DEC Phase

Dose-limiting toxicity (DLT) for the Safety Run-In Phase

Overall Response Rate (ORR)

Secondary outcome measures

Clinical Benefit Response (CBR)

Progression free survival (PFS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: ovarian cancer armExperimental Treatment2 Interventions

DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin

Group II: endometrial cancer armExperimental 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

~1940

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

858 Previous Clinical Trials

524,232 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor actively seeking participants at the moment?

"The clinicaltrials.gov website indicates that this study is no longer recruiting, with its original post from September 7th 2023 and last update on the 14th of the same month. However, at present there are 3147 other medical trials actively enlisting new patients into their research studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer

amy tiersten 2024. "Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06040970.

All > Uterine Cancer