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Monoclonal Antibodies

Sacituzumab Govitecan-hziy for Metastatic Cancer

Phase 4

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose date up to last dose date plus 30 days (approximately 3 years)

Awards & highlights

Study Summary

This trial is testing the long-term safety of a drug for people with metastatic solid tumors who are benefiting from the drug.

Who is the study for?

This trial is for people with metastatic cancer (cancer that has spread) who are currently benefiting from ongoing treatment with sacituzumab govitecan-hziy in a Gilead-sponsored study.Check my eligibility

What is being tested?

The study focuses on the continued use of sacituzumab govitecan-hziy, aiming to gather more information about its safety and effectiveness in patients whose cancer has spread.See study design

What are the potential side effects?

Possible side effects of sacituzumab govitecan-hziy include nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk or bleeding problems, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am currently receiving sacituzumab govitecan treatment in a Gilead study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date up to last dose date plus 30 days (approximately 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date up to last dose date plus 30 days (approximately 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to last dose date plus 30 days (approximately 3 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

Percentage of Participants Experiencing Laboratory Abnormalities

Percentage of Participants Experiencing any Adverse Events

Percentage of Participants Experiencing any Serious Adverse Events

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-hziyExperimental Treatment1 Intervention

Participants will receive sacituzumab govitecan-hziy at the dose that they were receiving in the parent study until they experience toxicity, disease progression, loss of clinical benefit, withdrawal of consent, lost to follow-up, or Sponsor termination of the study is documented. Participants who continued to receive sacituzumab govitecan-hziy in the Gilead sponsored parent study after disease progression (PD), may continue to receive sacituzumab govitecan-hziy until there is no clinical benefit as determined by the treating physician. No participant will receive more than 10 mg/kg dose of sacituzumab govitecan-hziy.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,083 Previous Clinical Trials

843,299 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,493 Total Patients Enrolled

Media Library

Sacituzumab Govitecan-hziy (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04319198 — Phase 4

Metastatic Tumor Research Study Groups: Sacituzumab Govitecan-hziy

Metastatic Tumor Clinical Trial 2023: Sacituzumab Govitecan-hziy Highlights & Side Effects. Trial Name: NCT04319198 — Phase 4

Sacituzumab Govitecan-hziy (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04319198 — Phase 4

Frequently Asked Questions

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

Could you provide me with a synopsis of the prior investigations involving Sacituzumab Govitecan-hiy?

"Sacituzumab Govitecan-hiy was first researched by Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley in 2018. Since then, two clinical trials have been concluded and there are 33 investigations ongoing as of today, with an abundance occuring within the confines of Chicago, Illinois."

Answered by AI

What maladies is Sacituzumab Govitecan-hiy ordinarily applied to combat?

"Sacituzumab Govitecan-hiy is a widely used therapeutic procedure, as well as having potential applications in pharmacotherapy and breast cancer."

Answered by AI

Are any additional participants being taken on for this trial?

"Unfortunately, no new candidates are being accepted presently. The trial was initially announced on August 4th 2020 and the last update to it occurred on November 7th 2022. If you're seeking additional studies, there are currently 2387 trials recruiting cancer patients and 33 specifically offering Sacituzumab Govitecan-hiy treatment options."

Answered by AI

What is the aggregate amount of subjects involved in this experiment?

"At this time, the clinical trial does not have any open recruitment. It was first posted on August 4th 2020 and last updated November 7th 2022. However, there are currently 2387 trials looking for cancer patients and 33 studies searching for participants to receive Sacituzumab Govitecan-hiy as a treatment."

Answered by AI

How deleterious is the application of Sacituzumab Govitecan-hiy for individuals?

"There is ample evidence that Sacituzumab Govitecan-hiy has been approved, thus the safety score for this medication was 3."

Answered by AI

Is this research endeavor unprecedented in its scope?

"As of now, 33 extant trials involving Sacituzumab Govitecan-hiy are being conducted in 418 cities across 32 nations. The initial trial was sponsored by Hoffmann-La Roche and involved 435 patients; it reached Phase 1 & 2 drug approval status. Since 2018, two further studies have been concluded."

Answered by AI

Are there any research centers conducting this experiment in North America?

"This trial is running out of University of Chicago in Chicago, Illinois; Next Oncology in Austin, Texas; and Illinois Cancer Specialists in Arlington Heights, Florida - among many other sites."

Answered by AI

Recent research and studies

American Journal of Clinical OncologyJournal

Sacituzumab Govitecan-hziy in Breast Cancer

Kwapisz, Dorota. 2022. “Sacituzumab Govitecan-hziy in Breast Cancer”. American Journal of Clinical Oncology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/coc.0000000000000919.

American Journal of Clinical OncologyJournal

Sacituzumab Govitecan-hziy in Breast Cancer

Kwapisz, Dorota. 2022. “Sacituzumab Govitecan-hziy in Breast Cancer”. American Journal of Clinical Oncology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/coc.0000000000000919.

clinicaltrials.govStudy

Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy

2020. "Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04319198.