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Monoclonal Antibodies
Sacituzumab Govitecan for Endometrial Cancer
Phase 2
Recruiting
Led By Alessandro D. Santin, M.D.
Research Sponsored by Alessandro Santin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have adequate hepatic function: Bilirubin ≤ 1.5 X laboratory normal. SGOT/SGPT ≤ 3 X laboratory normal or ≤ 5 X laboratory normal if known liver metastases.
Patients with measurable recurrent disease of any previous substage (I-IV) are eligible to enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Study Summary
This trial is testing a new drug for endometrial cancer that has come back or does not respond to other treatments.
Who is the study for?
This trial is for adults with persistent or recurrent endometrial carcinoma that worsened after platinum-based chemotherapy. They must have measurable disease, adequate organ function, and an ECOG performance status of 0 or 1. Participants need to be at least two weeks past prior treatments and recovered from acute toxicities. Pregnant women are excluded, as well as those with active second cancers, significant heart conditions, unstable medical issues, CNS metastases, certain viral infections, bleeding disorders or a history of severe reactions to similar drugs.Check my eligibility
What is being tested?
The study tests Sacituzumab Govitecan (IMMU-132) in patients with endometrial cancer that has returned or persisted despite previous treatment. It's a Phase 2 trial where all participants receive the drug without being randomly assigned to different groups.See study design
What are the potential side effects?
Potential side effects include allergic reactions related to irinotecan (a component of IMMU-132), gastrointestinal issues like nausea and diarrhea, risk of bleeding or intestinal obstruction due to the drug's mechanism which affects DNA replication in cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver functions are within the required range.
Select...
My cancer has come back and can be measured.
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A specialist confirmed my diagnosis through tissue examination.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have at least one tumor that can be measured by scans or physical exam.
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My blood tests show my bone marrow is functioning well.
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My kidney function is good, with creatinine ≤ 2.0 mg/dL.
Select...
My endometrial cancer has worsened after platinum chemotherapy or didn't respond to it.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Assess the safety profile of sacituzumab govitecan in endometrial cancer patients (adverse events as assessed by CTCAE v5.0)
Durable disease control rate (DDCR)
Duration of overall survival (OS)
+1 moreSide effects data
From 2020 Phase 3 trial • 529 Patients • NCT0257445540%
Fatigue
30%
Nausea
27%
Anaemia
25%
Neutropenia
23%
Constipation
21%
Decreased appetite
20%
Neutrophil count decreased
18%
Cough
18%
Dyspnoea
17%
Diarrhoea
16%
Alopecia
16%
Vomiting
13%
Hypokalaemia
13%
Headache
13%
Back pain
13%
Asthenia
12%
Pyrexia
12%
Aspartate aminotransferase increased
11%
Oedema peripheral
11%
Neuropathy peripheral
10%
Alanine aminotransferase increased
10%
White blood cell count decreased
8%
Urinary tract infection
8%
Myalgia
8%
Pain in extremity
7%
Platelet count decreased
7%
Arthralgia
7%
Dizziness
7%
Abdominal pain
7%
Weight decreased
6%
Mucosal inflammation
6%
Lymphocyte count decreased
6%
Bone pain
6%
Hypomagnesaemia
6%
Hypertension
6%
Thrombocytopenia
6%
Stomatitis
5%
Insomnia
5%
Pain
5%
Rash
5%
Blood alkaline phosphatase increased
5%
Hyperglycaemia
4%
Oropharyngeal pain
4%
Hypophosphataemia
4%
Anxiety
4%
Abdominal pain upper
4%
Breast pain
3%
Upper respiratory tract infection
3%
Musculoskeletal chest pain
3%
Dysgeusia
3%
Lymphoedema
3%
Pruritus
3%
Pleural effusion
3%
Gastrooesophageal reflux disease
3%
Chills
2%
Nasopharyngitis
2%
Hypocalcaemia
2%
Febrile neutropenia
2%
Sepsis
2%
Pneumonia
1%
Nasal congestion
1%
Dyspnoea exertional
1%
Dry skin
1%
Rash maculo-papular
1%
Pericardial effusion
1%
Pulmonary embolism
1%
Respiratory failure
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment of Physician's Choice (TPC)
Sacituzumab Govitecan
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sacituzumab GovitecanExperimental Treatment1 Intervention
Sacituzumab govitecan will be administered at 10 mg/kg weekly as an infusion for 2 consecutive weeks (2 weekly doses plus 1 week without treatment represents a single 3 week cycle). Treatment can be continued without a rest period in the absence of progression of disease or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
Alessandro SantinLead Sponsor
3 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Endometrial Cancer
50 Patients Enrolled for Endometrial Cancer
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,212 Total Patients Enrolled
1 Trials studying Endometrial Cancer
515 Patients Enrolled for Endometrial Cancer
Yale UniversityLead Sponsor
1,853 Previous Clinical Trials
2,738,511 Total Patients Enrolled
3 Trials studying Endometrial Cancer
92 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stable brain metastases, not on high steroids, and no carcinomatous meningitis.My liver functions are within the required range.I can provide a sample of my tumor for TROP-2 testing.I have previously received immunotherapy, with or without chemotherapy.I have HIV with a high viral load and take medication that could affect my treatment.My cancer has come back and can be measured.I do not have an active second cancer, or it has been in remission for over 3 years.My surgery removed most or all of my tumor.You have Gilbert's disease.A specialist confirmed my diagnosis through tissue examination.I have recovered from serious side effects of my last treatment, except for mild nerve pain or hair loss.I stopped taking high doses of steroids more than 2 weeks ago, but may still be on a low dose.I have had a severe allergic reaction or major stomach issues from irinotecan.I have been treated with topoisomerase I inhibitors before.I have at least one measurable tumor to track treatment response.I am fully active or restricted in physically strenuous activity but can do light work.It has been over 2 weeks since my last cancer treatment or major surgery.I haven't had serious bleeding, blockages in my intestines, or a hole in my gut in the last 6 months.I have at least one tumor that can be measured by scans or physical exam.My blood tests show my bone marrow is functioning well.I have had severe lung problems like COPD in the last 6 months.My kidney function is good, with creatinine ≤ 2.0 mg/dL.I have had several treatments for my returning endometrial cancer.I have a bleeding disorder or am currently experiencing active bleeding.I do not have serious heart problems like uncontrolled high blood pressure or heart failure.I do not have an active hepatitis B or C infection.My endometrial cancer has worsened after platinum chemotherapy or didn't respond to it.I have an uncontrolled seizure disorder or active neurological disease.I have severe appetite loss, nausea, vomiting, diarrhea, or signs of a blocked intestine.I do not have any unstable health issues like heart problems, blood clots, stroke, kidney or liver problems, or infections needing IV antibiotics.I am 18 years old or older.I have recovered from any major surgery before starting treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab Govitecan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this endeavor a pioneering clinical trial?
"Currently, 33 trials of Sacituzumab Govitecan are underway in 418 cities spread across 32 countries. This drug, sponsored by Hoffmann-La Roche and first tested in 2018 on 435 patients, has completed its Phase 1 & 2 clinical trial phases. Since then two more studies have been successfully concluded."
Answered by AI
Are there still openings available for this research endeavor?
"As indicated on clinicaltrials.gov, this medical trial is currently open for enrollment and was initially made available to the public on February 25th 2020 with a recent update occurring April 4th 2022."
Answered by AI
What is the current capacity of enrollees for this medical investigation?
"Affirmative. According to the data hosted on clinicaltrials.gov, this research trial is currently seeking volunteers. It was first published on February 25th 2020 and has most recently been updated on April 4th 2022. Enrolment requires 50 individuals from one centre."
Answered by AI
Could you please provide an overview of Sacituzumab Govitecan's prior research endeavours?
"Presently, there are 33 ongoing clinical trials examining the efficacy of Sacituzumab Govitecan. Of these studies, 5 are in Phase 3 and have been registered at 1397 different sites around the world, with a considerable concentration located in Birmingham and Victoria."
Answered by AI
To what extent can Sacituzumab Govitecan be deemed hazardous for people?
"Since there is limited data to assess efficacy, but some evidence of safety, the Sacituzumab Govitecan received a rating of 2."
Answered by AI
What conditions is Sacituzumab Govitecan typically prescribed for?
"Sacituzumab Govitecan is a therapeutic agent that can be utilized to treat pharmacotherapeutic conditions including uc 84572 and breast cancer."
Answered by AI
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