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Anti-metabolites

FF-10832 for Cancer

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 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 three months
Histologically or cytologically confirmed cholangiocarcinoma or gall bladder carcinoma that is metastatic pancreatic adenocarcinoma following progression or relapse or unresectable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what the highest dose is that patients can tolerate without severe side effects, as well as what side effects occur at different doses.

Who is the study for?
Adults with certain advanced solid tumors, including cholangiocarcinoma or gall bladder carcinoma, who have progressed after prior treatments and are not currently pregnant or breastfeeding. Participants must have a good performance status (ECOG ≤ 1), a life expectancy of at least 3 months, and no severe allergies to gemcitabine.Check my eligibility
What is being tested?
The trial is testing FF-10832 Gemcitabine Liposome Injection to find the safest high dose for future studies. It will look at how patients tolerate this drug, what side effects occur at different doses, and recommend a dose for Phase 2 trials in people with advanced solid tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to the infusion process, fatigue, blood-related issues such as low counts leading to increased infection risk or bleeding problems, liver function changes, kidney function changes and gastrointestinal symptoms like nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread, doesn't respond to standard treatments, or has no treatment expected to extend life by 3 months.
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My cancer is confirmed to be cholangiocarcinoma, gall bladder carcinoma, or metastatic pancreatic adenocarcinoma and cannot be surgically removed.
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I have recovered from my last cancer treatment and it's been at least 3 weeks.
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I can carry out all my self-care but cannot do heavy physical work.
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My cancer did not respond or was not eligible for FGFR/IDH mutation treatments.
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My cancer has worsened after treatment with gemcitabine and possibly cisplatin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 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
Therapeutic procedure
Determine maximun tolerated dose (MTD) of FF-10832
Identify dose-limiting toxicities (DLT) of FF-10832
Secondary outcome measures
Disease Assessment by CT or MRI + PET scan for pancreatic cancer
Cognitive Therapy
Duration of Response
+4 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D)Experimental Treatment1 Intervention
For patients with biliary tract cancer: FF-10832 Gemcitabine Liposome Injection, RP2D administered intravenously (IV) on Day 1 of each 21-day cycle
Group II: Cohort 4: Treatment at 8 mg/m2Experimental Treatment1 Intervention
FF-10832 Gemcitabine Liposome Injection, 8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Group III: Cohort 3: Treatment at 4.8 mg/m2Experimental Treatment1 Intervention
FF-10832 Gemcitabine Liposome Injection, 4.8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Group IV: Cohort 2: Treatment at 2.4 mg/m2Experimental Treatment1 Intervention
FF-10832 Gemcitabine Liposome Injection, 2.4 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Group V: Cohort 1: Treatment at 1.2 mg/m2Experimental Treatment1 Intervention
FF-10832 Gemcitabine Liposome Injection, 1.2 mg/m2 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
576 Total Patients Enrolled

Media Library

Gemcitabine Liposome Injection (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03440450 — Phase 1
Solid Tumors Research Study Groups: Cohort 2: Treatment at 2.4 mg/m2, Cohort 3: Treatment at 4.8 mg/m2, Cohort 4: Treatment at 8 mg/m2, Cohort 1: Treatment at 1.2 mg/m2, Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D)
Solid Tumors Clinical Trial 2023: Gemcitabine Liposome Injection Highlights & Side Effects. Trial Name: NCT03440450 — Phase 1
Gemcitabine Liposome Injection (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03440450 — 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 current capacity for this trial in terms of participants?

"Affirmative. Data available on clinicaltrials.gov confirms that this trial, which was first shared in March 2018, is actively recruiting participants. The study requires 90 individuals to be enrolled across 3 different medical sites."

Answered by AI

What objectives are being pursued by this experiment?

"As stated by the clinical trial sponsor, Fujifilm Pharmaceuticals U.S.A., Inc., this study's main objective is to assess Treatment Emergent Adverse Events (TEAE) over a 2.5 year period. Additionally, secondary outcomes such as overall survival, disease assessment via CT/MRI+PET scan for pancreatic cancer and duration of response will also be evaluated during the project's lifetime."

Answered by AI

Are there still opportunities for people to participate in this trial?

"As per clinicaltrials.gov, this medical trial is presently enrolling patients and was initially posted on March 22nd 2018 with a final edit made on October 19th 2022."

Answered by AI

Has the FDA authorized FF-10832 Gemcitabine Liposome Injection for clinical use?

"Given the limited data on FF-10832 Gemcitabine Liposome Injection's safety and efficacy, its risk rating is low at 1."

Answered by AI

What other empirical research has been done related to FF-10832 Gemcitabine Liposome Injection?

"Currently, 446 active trials are being conducted with the drug FF-10832 Gemcitabine Liposome Injection. Of those studies, 134 have reached Phase 3. While Woolloongabba in Queensland is hosting most of these clinical investigations, there are also 24565 other sites across the globe conducting related experiments."

Answered by AI

What therapeutic uses is FF-10832 Gemcitabine Liposome Injection being employed to treat?

"Patients diagnosed with small cell lung cancer (SCLC), head and neck carcinoma, or pancreatic adenocarcinoma in its advanced stages can be treated using FF-10832 Gemcitabine Liposome Injection."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors
2018. "A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03440450.
~5 spots leftby Sep 2024
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