FF-10832 for Cancer

Recruiting at 6 trial locations

Overseen By FPHU Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

90 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid tumors including biliary tract cancer

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be at least 3 weeks past your last chemotherapy, radiotherapy, major surgery, or experimental treatment before starting the trial.

What data supports the effectiveness of the drug FF-10832 (Gemcitabine Liposome Injection) for cancer treatment?

Research shows that FF-10832, a form of gemcitabine packaged in tiny fat-like particles called liposomes, improves how long the drug stays in the blood and targets tumors better, which helps it work more effectively against pancreatic cancer in animal studies. ^{1 2 3 4 5}

Is FF-10832 (Gemcitabine Liposome Injection) safe for humans?

Gemcitabine, which is similar to FF-10832, is generally well tolerated with mild side effects like flu-like symptoms, mild fever, and occasional nausea. Serious side effects are rare, but some patients may experience low blood cell counts or mild kidney issues. ^{1 2 6 7 8}

What makes the drug FF-10832 unique for cancer treatment?

FF-10832 is unique because it is a liposome-encapsulated form of gemcitabine, which improves the drug's stability in the bloodstream and enhances its delivery to tumors, potentially leading to better treatment outcomes compared to standard gemcitabine. ^{1 2 3 5 9}

Eligibility Criteria

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.

Inclusion Criteria

I have had 3 or fewer treatments for my cancer.

My cancer has spread, doesn't respond to standard treatments, or has no treatment expected to extend life by 3 months.

I am 18 years old or older.

Exclusion Criteria

I haven't had treatments known to extend life by 3 months.

I have not used IV antibiotics for an infection in the last week.

Prior hypersensitivity to gemcitabine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation Treatment

Eligible patients receive FF-10832 in 28-day or 21-day cycles until disease progression or unacceptable adverse events

Variable, based on individual response

Visits on Days 1 and 15 of each cycle

Expansion Treatment

One cohort of biliary tract cancer patients receives FF-10832 at the RP2D in 21-day cycles

Variable, based on individual response

Visits on Day 1 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

2.5 years

Treatment Details

Interventions

• Gemcitabine Liposome Injection

Trial Overview 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.

Participant Groups

Group I: Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D) Experimental Treatment 1 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/m2 Experimental Treatment 1 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/m2 Experimental Treatment 1 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/m2 Experimental Treatment 1 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/m2 Experimental Treatment 1 Intervention

FF-10832 Gemcitabine Liposome Injection, 1.2 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Who Is Running the Clinical Trial?

Fujifilm Pharmaceuticals U.S.A., Inc.

Lead Sponsor

Trials

9

Recruited

680+

No collaboration

Collaborator

Trials

3

Recruited

280+

Findings from Research

Liposomal encapsulation of gemcitabine (FF-10832) significantly improved its pharmacokinetics, showing 672 times higher plasma levels and 1047 times higher tumor levels compared to unencapsulated gemcitabine in mouse models of pancreatic cancer.

FF-10832 demonstrated better antitumor activity and tolerability than standard gemcitabine, indicating its potential as a more effective treatment option for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Liposomal Gemcitabine, FF-10832, Improves Plasma Stability, Tumor Targeting, and Antitumor Efficacy of Gemcitabine in Pancreatic Cancer Xenograft Models. Matsumoto, T., Komori, T., Yoshino, Y., et al.[2022]

Gemcitabine-loaded PEGylated liposomes (L-GEM) showed significantly greater antitumor activity against pancreatic cancer cell lines compared to free gemcitabine, with lower effective doses needed to reduce cell viability.

In vivo studies in mice demonstrated that L-GEM not only inhibited tumor growth more effectively than free gemcitabine but also improved survival rates without increasing toxicity, supporting its potential for clinical development in pancreatic cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo activity of gemcitabine-loaded PEGylated small unilamellar liposomes against pancreatic cancer. Cosco, D., Bulotta, A., Ventura, M., et al.[2022]

In a study involving four patients with advanced pancreatic or breast cancer, fixed dose rate gemcitabine administered intravenously was found to be well tolerated, with the main side effect being reversible myelosuppression.

No significant cardiac or renal toxicity was observed, suggesting that iv-FDR gemcitabine could be a safe treatment option worth further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical observations on safety of fixed dose rate gemcitabine chemotherapy by intravenous infusion. Yao, CY., Huang, XE., Tang, JH., et al.[2022]

In a retrospective study of 30 patients with recurrent or metastatic pancreatic cancer, gemcitabine (GEM) showed an overall response rate of 11% and a disease control rate of 54%, indicating some effectiveness in managing the disease.

While GEM treatment was associated with significant grade 3 or 4 neutropenia in 46% of patients, non-hematological toxicities were mild, suggesting that GEM has a manageable safety profile despite its limited efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study of gemcitabine therapy for recurrent or metastatic pancreatic cancer]. Moriwaki, T., Hyodo, I., Nishina, T., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Liposomal Gemcitabine, FF-10832, Improves Plasma Stability, Tumor Targeting, and Antitumor Efficacy of Gemcitabine in Pancreatic Cancer Xenograft Models. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

In vivo activity of gemcitabine-loaded PEGylated small unilamellar liposomes against pancreatic cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Antimetastatic effects of liposomal gemcitabine and empty liposomes in an orthotopic mouse model of pancreatic cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Gemcitabine/cannabinoid combination triggers autophagy in pancreatic cancer cells through a ROS-mediated mechanism. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

PEGylated liposomal Gemcitabine: insights into a potential breast cancer therapeutic. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Gemcitabine--a safety review. [2022]

7. Thailand pubmed.ncbi.nlm.nih.gov

Clinical observations on safety of fixed dose rate gemcitabine chemotherapy by intravenous infusion. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

[Clinical study of gemcitabine therapy for recurrent or metastatic pancreatic cancer]. [2022]

9. England pubmed.ncbi.nlm.nih.gov

FF-10832 enables long survival via effective gemcitabine accumulation in a lethal murine peritoneal dissemination model. [2022]