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Monoclonal Antibodies

Irinotecan Sucrosofate for Fallopian Tube Carcinoma

Phase 2

Waitlist Available

Led By Daniela E Matei, M.D.

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 months

Awards & highlights

Study Summary

This trial is testing the effect of irinotecan liposome and bevacizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Eligible Conditions

Fallopian Tube Carcinoma
Peritoneal Carcinoma
Fallopian Tube Cancer
Ovarian Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Objective Response Rate (ORR)

Secondary outcome measures

Clinical Benefit Rate (CBR)

Duration of Response (DOR)

Duration of Stable Disease

+5 more

Side effects data

From 2021 Phase 2 trial • 3 Patients • NCT04753216

100%

Diarrhea

100%

Hyperglycemia

67%

Lymphocyte count decreased

67%

Nausea

67%

Neutrophil count decreased

67%

Hypoalbuminemia

67%

Hypokalemia

67%

Hyponatremia

67%

Fatigue

33%

Abdominal pain

33%

Platelet count decreased

33%

Proteinuria

33%

Creatinine increased

33%

Hypertension

33%

Hypocalcemia

33%

Hypophosphatemia

33%

Alkaline phosphatase increased

33%

Anemia

33%

Aspartate aminotransferase increased

33%

Blood bilirubin increased

33%

Constipation

33%

Cough

33%

Dehydration

33%

Dizziness

33%

Dyspepsia

33%

Eosinophilia

33%

Epistaxis

33%

Fall

33%

Hyperphosphatemia

33%

Ascites

33%

Sinus tachycardia

33%

Vomiting

33%

White blood cell decreased

33%

Hypotension

33%

Injection site reaction

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Bevacizumab, Irinotecan Sucrosofate)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (bevacizumab, irinotecan sucrosofate)Experimental Treatment2 Interventions

Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5280

Irinotecan Sucrosofate

2021

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ipsen BiopharmaceuticalsUNKNOWN

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,150 Total Patients Enrolled

23 Trials studying Fallopian Tube Carcinoma

6,798 Patients Enrolled for Fallopian Tube Carcinoma

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,228 Total Patients Enrolled

Frequently Asked Questions

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

What adverse effects may result from Irinotecan Sucrosofate treatment?

"There is limited data supporting the safety of Irinotecan Sucrosofate, earning it a score of 2. So far, there have been no investigations into its efficacy."

Answered by AI

Is enrollment still available for this investigation?

"Affirmative. Clinicaltrials.gov hosts information attesting to this trial's active recruitment of applicants, commencing on March 16th 2021 and most recently updated on March 10th 2022. 30 humans are required at a sole clinical site for the study’s completion."

Answered by AI

How many participants are being taken into consideration for this research?

"Confirmed. Data hosted on clinicaltrials.gov affirms that this medical investigation, which was initially publicized on 16th March 2021, is actively searching for volunteers. Approximately 30 patients need to be gathered from a single centre."

Answered by AI

Are there any other research initiatives that have looked into the efficacy of Irinotecan Sucrosofate?

"Currently, 570 trials are devoted to the study of Irinotecan Sucrosofate. Of these studies, 129 have reached Phase 3 and 23367 individual sites around Woolloongabba, Queensland are running them."

Answered by AI

What therapeutic purpose does Irinotecan Sucrosofate serve?

"Irinotecan Sucrosofate is commonly used in the treatment of recurrent platinum-resistant epithelial ovarian cancer. This medication has also been deemed efficacious for malignant neoplasms, colorectal carcinoma and recurrent platinum sensitive primary peritoneal cancer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Daniela Matei 2021. "Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04753216.