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Topoisomerase I inhibitor

FF-10850 Topotecan Liposome Injection for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Fujifilm Pharmaceuticals U.S.A., Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed metastatic and/or unresectable solid tumor, relapsed or refractory to standard therapy, or for which no standard therapy is available that is expected to improve survival by at least 3 months
At least 3 weeks beyond the last chemotherapy (or 3 half-lives, whichever is shorter), radiotherapy, major surgery, or experimental treatment, and recovered from all acute toxicities (≤ Grade 1), prior to the first dose of FF-10850
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing the safety of a new cancer drug called FF-10850. They will give the drug to patients with advanced solid tumors to see what the maximum tolerated dose is and what side effects occur.

Who is the study for?
Adults (≥18 years) with advanced solid tumors that are metastatic/unresectable, have failed standard treatments or have no better options. Participants must be recovered from previous therapies, have a life expectancy of ≥3 months, stable heart rhythm and adequate organ function. Pregnant/breastfeeding individuals, those with severe topotecan allergies, recent serious cardiac issues, active CNS malignancies or certain infections like HIV/HBV/HCV are excluded.Check my eligibility
What is being tested?
The trial is testing FF-10850 Topotecan Liposome Injection to find the safest and most effective dose for treating advanced solid tumors. It aims to identify the maximum tolerated dose (MTD), any dose-limiting toxicities (DLTs), and recommend a Phase 2 dosage based on these findings.See study design
What are the potential side effects?
While specific side effects for FF-10850 aren't listed here, typical reactions to topotecan can include lowered blood cell counts leading to increased infection risk or bleeding tendencies, fatigue, hair loss, nausea and vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.
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I have recovered from my last cancer treatment and it's been at least 3 weeks.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My blood counts are stable without needing transfusions.
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I can carry out all my self-care but cannot do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Determine incidence of Treatment Emergent Adverse Events
Determine maximun tolerated dose (MTD) of FF-10850
Determine recommended Phase 2 dose (RP2D) FF-10850
+1 more
Secondary outcome measures
Characterize the pharmacokinetics (PK) of FF-10850 in plasma: AUC
Characterize the pharmacokinetics (PK) of FF-10850 in plasma: CL
Characterize the pharmacokinetics (PK) of FF-10850 in plasma: Cmax
+9 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort E5: Treatment at Recommended Phase 2 Dose (RP2D)Experimental Treatment1 Intervention
For patients with advanced Merkel cell carcinoma: FF-10850 Topotecan Liposome Injection, RP2D administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Group II: Cohort E1: Treatment at Recommended Phase 2 Dose (RP2D)Experimental Treatment1 Intervention
For patients with advanced ovarian cancer: FF-10850 Topotecan Liposome Injection, RP2D administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Group III: Cohort 3: Treatment at Dose Level 3Experimental Treatment1 Intervention
FF-10850 Topotecan Liposome Injection, Dose Level 3 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Group IV: Cohort 2: Treatment at Dose Level 2Experimental Treatment1 Intervention
FF-10850 Topotecan Liposome Injection, Dose Level 2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Group V: Cohort 1: Treatment at Dose Level 1Experimental Treatment1 Intervention
FF-10850 Topotecan Liposome Injection, Dose Level 1 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Find a Location

Who is running the clinical trial?

Fujifilm Pharmaceuticals U.S.A., Inc.Lead Sponsor
8 Previous Clinical Trials
570 Total Patients Enrolled

Media Library

FF-10850 Topotecan Liposome Injection (Topoisomerase I inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04047251 — Phase 1
Solid Tumors Research Study Groups: Cohort E1: Treatment at Recommended Phase 2 Dose (RP2D), Cohort 3: Treatment at Dose Level 3, Cohort E5: Treatment at Recommended Phase 2 Dose (RP2D), Cohort 1: Treatment at Dose Level 1, Cohort 2: Treatment at Dose Level 2
Solid Tumors Clinical Trial 2023: FF-10850 Topotecan Liposome Injection Highlights & Side Effects. Trial Name: NCT04047251 — Phase 1
FF-10850 Topotecan Liposome Injection (Topoisomerase I inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04047251 — Phase 1

Frequently Asked Questions

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

What is the upper limit of individuals participating in this research project?

"The sponsor, Fujifilm Pharmaceuticals U.S.A., Inc., is in need of 96 eligible patients to run the trial from multiple locations including Icahn School of Medicine at Mount Sinai (New york City) and HonorHealth (Scottsdale)."

Answered by AI

Are there any Canadian medical centers offering this research initiative?

"At the moment, 5 sites are hosting this trial - two of which are in New york and Scottsdale, one being located in Denver. Additionally, there are other locations that patients can visit to participate. It is advised to seek out the closest site possible to reduce travel needs if you choose to take part."

Answered by AI

What therapeutic applications has FF-10850 Topotecan Liposome Injection been demonstrated to be efficacious for?

"FF-10850 Topotecan Liposome Injection is a commonly prescribed drug for malignant neoplasms of the ovary. However, it's also been approved to treat various other diseases such as acute myelocytic leukemia and sarcoma."

Answered by AI

What adverse effects could occur due to using FF-10850 Topotecan Liposome Injection?

"With minimal clinical data available, our team deemed the safety of FF-10850 Topotecan Liposome Injection to be a score 1. This is due to it being in its first phase of testing, where risk and efficacy are still largely unknown."

Answered by AI

Is there a precedent for the use of FF-10850 Topotecan Liposome Injection in previous clinical trials?

"Currently, 61 different trials are running to examine the efficacy of FF-10850 Topotecan Liposome Injection. 17 of these studies have progressed to Phase 3 and there are a total of 3194 medical sites where this drug is being examined. Although primarily located in Sioux Falls, South dakota, the research extends beyond that locale into other regions as well."

Answered by AI

Are recruitment efforts still ongoing for this research project?

"Per the clinicaltrials.gov webpage, this medical trial is still actively seeking participants. It was posted to the website on November 14th 2019 and updated most recently on October 19th 2022."

Answered by AI

What objectives is this investigation trying to meet?

"Fujifilm Pharmaceuticals U.S.A., Inc., the trial sponsor, has indicated that this study's central aim is to establish a recommended Phase 2 dose (RP2D) for FF-10850 over 4 years of observation. Secondary objectives include characterizing plasma clearance, determining objective response rate via RECIST v.1.1, and evaluating progression-free survival from treatment start date until death or disease recurrence occurs"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors
2019. "A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04047251.
~3 spots leftby Jul 2024
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