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Monoclonal Antibodies

Sacituzumab Govitecan for Ovarian Cancer

Q: What has been revealed about the security of administering Sacituzumab govitecan, 10 mg/kg?

<p>A score of 2 was given to Sacituzumab govitecan, 10 mg/kg due to the lack of efficacy data and presence of safety related information from Phase 2 trials.</p>

Q: Is enrollment still open for participation in this clinical experiment?

<p>According to clinicaltrials.gov, there are no open slots for this trial as it was most recently updated on August 31st 2023. Despite not being able to join this particular research project, 561 other medical studies have vacancies that prospective participants can consider joining.</p>

Phase 2

Recruiting

Led By Alessandro Santin, M.D.

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have platinum-resistant (i.e., platinum-free interval <6 months) recurrent or persistent histologically confirmed epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Patients may have serous, endometrioid, clear cell, (pure or mixed), or undifferentiated histology.

All patients must have measurable disease. Measurable disease is defined as lesions which can be measured by physical examination or by means of medical imaging techniques. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation or plain x-ray, or ≥ 10 mm when measured by spiral CT and/or MRI. Ascites and pleural effusions are not to be considered measurable disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

Study Summary

This trial tests a new drug to treat ovarian cancer that didn't respond to other treatments.

Who is the study for?

This trial is for adults with platinum-resistant ovarian cancer, including fallopian tube or primary peritoneal cancers, who have had no more than two prior chemotherapies for recurrent disease. Participants must be in good health otherwise, not pregnant or breastfeeding, and able to use contraception. They should have recovered from previous treatments and surgeries and have adequate organ function.Check my eligibility

What is being tested?

The study tests Sacituzumab Govitecan (IMMU-132) on patients with specific types of ovarian cancer that are resistant to platinum-based chemotherapy. It's a Phase 2 trial focusing on those whose disease has returned after treatment. The drug's effectiveness will be measured against the size of tumors over time.See study design

What are the potential side effects?

While the document doesn't list side effects explicitly, similar drugs can cause nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, hair loss (alopecia), allergic reactions and possibly diarrhea due to its mechanism as a topoisomerase I inhibitor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My ovarian, fallopian tube, or peritoneal cancer is resistant to platinum treatment.

Select...

I have at least one tumor that can be measured by scans or physical exam.

Select...

My cancer has come back and can be measured.

Select...

My blood tests show my white cells, platelets, and neutrophils are within the required range.

Select...

I am 18 years old or older.

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I can provide a sample of my tumor for TROP-2 testing.

Select...

My kidney function is good, with creatinine at or below 2.0 mg/dL.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

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

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 ovarian cancer patients (adverse events as assessed by CTCAE v5.0)

Durable disease control rate (DDCR)

Duration of overall survival (OS)

+1 more

Side effects data

From 2020 Phase 3 trial • 529 Patients • NCT02574455

40%

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

Urinary tract infection

Myalgia

Pain in extremity

Platelet count decreased

Arthralgia

Dizziness

Abdominal pain

Weight decreased

Mucosal inflammation

Lymphocyte count decreased

Bone pain

Hypomagnesaemia

Hypertension

Thrombocytopenia

Stomatitis

Insomnia

Pain

Rash

Blood alkaline phosphatase increased

Hyperglycaemia

Oropharyngeal pain

Hypophosphataemia

Anxiety

Abdominal pain upper

Breast pain

Upper respiratory tract infection

Musculoskeletal chest pain

Dysgeusia

Lymphoedema

Pruritus

Pleural effusion

Gastrooesophageal reflux disease

Chills

Nasopharyngitis

Hypocalcaemia

Febrile neutropenia

Sepsis

Pneumonia

Nasal congestion

Dyspnoea exertional

Dry skin

Rash maculo-papular

Pericardial effusion

Pulmonary embolism

Respiratory failure

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment of Physician's Choice (TPC)

Sacituzumab Govitecan

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sacituzumab govitecan, 10 mg/kgExperimental Treatment1 Intervention

Sacituzumab govitecan, 10 mg/kg for the first 2 weeks of 21-day cycle until progression or adverse effects prohibit further treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab govitecan

2017

Completed Phase 3

~530

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,421 Total Patients Enrolled

3 Trials studying Ovarian Cancer

375 Patients Enrolled for Ovarian Cancer

Alessandro SantinLead Sponsor

3 Previous Clinical Trials

120 Total Patients Enrolled

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

848,459 Total Patients Enrolled

5 Trials studying Ovarian Cancer

821 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

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

What has been revealed about the security of administering Sacituzumab govitecan, 10 mg/kg?

"A score of 2 was given to Sacituzumab govitecan, 10 mg/kg due to the lack of efficacy data and presence of safety related information from Phase 2 trials."

Answered by AI

Is enrollment still open for participation in this clinical experiment?

"According to clinicaltrials.gov, there are no open slots for this trial as it was most recently updated on August 31st 2023. Despite not being able to join this particular research project, 561 other medical studies have vacancies that prospective participants can consider joining."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients

Alessandro Santin 2024. "A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028932.