96 Participants Needed

FF-10850 Topotecan Liposome Injection for Solid Tumors

Recruiting at 4 trial locations
FS
Overseen ByFPHU Study Coordinator
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests a new form of a cancer drug called topotecan, which is packed in tiny fat bubbles to make it work better and be safer. It targets patients with advanced ovarian cancer and Merkel cell carcinoma who need new treatment options. The drug stops cancer cells from growing by attacking their DNA.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you must stop all current medications. However, you cannot take medications that may cause QTc prolongation or induce Torsades de Pointes, unless they are essential for your care as determined by the Investigator.

What data supports the idea that FF-10850 Topotecan Liposome Injection for Solid Tumors is an effective drug?

The available research shows that FF-10850 Topotecan Liposome Injection, also known as Hycamtin, has demonstrated effectiveness in treating various types of cancer. For instance, in ovarian cancer, it showed a response rate of 20% compared to 13% for another drug, paclitaxel, and patients had a longer time before the disease progressed. In small cell lung cancer, it had a 39% response rate in patients who were sensitive to treatment. These results suggest that FF-10850 can be an effective option for certain cancers, with manageable side effects.12345

What safety data is available for FF-10850 Topotecan Liposome Injection?

The safety data for topotecan, including its liposomal formulations, indicates that myelosuppression, primarily neutropenia, is the principal dose-limiting toxicity. Topotecan is generally well-tolerated with predictable and manageable side effects, mostly hematological. Liposomal formulations, such as PEGylated liposomal topotecan, have shown improved therapeutic efficiency and reduced toxicity compared to conventional formulations. However, further optimization and trials are needed to fully assess the safety and efficacy of these formulations.12367

Is the drug FF-10850 Topotecan Liposome Injection a promising treatment for solid tumors?

Yes, FF-10850 Topotecan Liposome Injection shows promise as a treatment for solid tumors. It has been optimized to stay in the body longer, which can help it work better against cancer cells. Studies have shown it to be more effective than regular topotecan in treating certain cancers, like ovarian cancer, and it is being explored for use in other types of cancer as well.24578

Eligibility Criteria

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.

Inclusion Criteria

Hemoglobin (Hb) ≥ 9 g/dL
My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.
I have recovered from my last cancer treatment and it's been at least 3 weeks.
See 11 more

Exclusion Criteria

I have not used IV antibiotics for an infection in the last week.
I haven't had treatments known to extend life by 3 months.
Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Approximately 48 patients are planned for the dose-escalation phase to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of FF-10850.

3 years
Visits every 28 days

Cohort Expansion

Two additional cohorts are planned to be treated at the recommended Phase 2 dose (RP2D) for advanced ovarian cancer and Merkel cell carcinoma.

3 years
Visits every 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months to assess survival.

4 years

Treatment Details

Interventions

  • FF-10850 Topotecan Liposome Injection
Trial OverviewThe 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.
Participant Groups
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

FF-10850 Topotecan Liposome Injection is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Hycamtin for:
  • Ovarian cancer
  • Cervical cancer
  • Small cell lung cancer
🇺🇸
Approved in United States as Hycamtin for:
  • Ovarian cancer
  • Cervical cancer
  • Small cell lung cancer

Find a Clinic Near You

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

Topotecan, a drug that targets topoisomerase I, has shown significant antitumor activity when combined with various chemotherapy agents like cisplatin and doxorubicin in both adult and pediatric patients with solid tumors.
The main side effect of these combination therapies is myelosuppression, particularly neutropenia, which limits the dosage; however, many early studies have reported major responses, indicating the potential effectiveness of these regimens.
Topotecan in combination chemotherapy.Rowinsky, EK., Kaufmann, SH.[2017]
Topotecan, a topoisomerase-I inhibitor, was found to be highly effective against glioblastoma cell lines, showing no negative interaction when combined with ionizing radiation, indicating a potentially effective treatment strategy for this type of tumor.
In contrast, normal fibroblasts exhibited an antagonistic response to the combination of topotecan and radiation, suggesting that this treatment may be safer for normal tissues while still effectively targeting tumor cells.
Differential response of tumor cells and normal fibroblasts to fractionated combined treatment with topotecan and ionizing radiation.Ohneseit, PA., Wildemann, A., Herskind, C., et al.[2013]
Topotecan has demonstrated effectiveness in treating various cancers, including metastatic ovarian cancer and recurrent small cell lung cancer, with response rates of 20% in ovarian cancer compared to 13% for paclitaxel, and a notable median survival of 5.4 months in SCLC patients.
The drug is generally well-tolerated, with myelosuppression being the main side effect, but serious complications are rare, making it a manageable option for patients undergoing treatment.
Topotecan, an active new antineoplastic agent: review and current status.Carmichael, J., Ozols, RF.[2019]

References

Topotecan in combination chemotherapy. [2017]
Differential response of tumor cells and normal fibroblasts to fractionated combined treatment with topotecan and ionizing radiation. [2013]
Topotecan, an active new antineoplastic agent: review and current status. [2019]
Future role of topotecan in the treatment of lung cancer. [2017]
Long-term topotecan therapy in recurrent or persistent ovarian cancer. [2020]
In-vitro cytotoxicity, in-vivo biodistribution and anti-tumour effect of PEGylated liposomal topotecan. [2018]
Optimization of liposomal topotecan for use in treating neuroblastoma. [2022]
Topophore C: a liposomal nanoparticle formulation of topotecan for treatment of ovarian cancer. [2021]