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FP-045 for Fanconi Anemia

Phase 1 & 2

Recruiting

Research Sponsored by Foresee Pharmaceuticals Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Male or female aged 3-25

Documented Fanconi anemia by chromosome breakage analysis

Must not have

Has a history of bone marrow or stem cell transplant

Has active Hepatitis B or C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, FP 045, to see if it is safe and works well in treating patients with Fanconi anemia who have not had a bone marrow transplant. The trial will enroll 14-18 patients, who will each receive the drug at 3 different dose levels for 28 days each.

Who is the study for?

This trial is for young people aged 3-25 with Fanconi anemia and mild to moderate bone marrow failure. Participants must not have had a transplant or certain medical conditions, including active infections or liver issues. They should use effective birth control if applicable.

What is being tested?

The study tests FP-045, given orally in escalating doses over three stages, each lasting 28 days. It aims to find the best dose and assess safety, how the body processes the drug (PK), and its initial effectiveness in treating Fanconi anemia.

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at varying degrees related to digestive health, blood cell counts, potential liver function changes due to medication processing, and general discomforts like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 25 years old.

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I have been diagnosed with Fanconi anemia through a specific genetic test.

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I have a mild to moderate decrease in blood cell production with at least one type of blood cell affected.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a bone marrow or stem cell transplant.

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I have active Hepatitis B or C.

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I am receiving treatment for active graft versus host disease.

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I need a strong CYP3A4 inhibitor medication.

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I have been diagnosed with myelodysplastic syndrome or acute leukemia.

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My liver enzymes are high or my kidney function is low.

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I am currently fighting an infection in my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Optimal Biologic Dose (OBP) of FP-045

stabilizing or improving cytopenia in FA

Secondary study objectives

Safety and tolerability

pharmacokinetic profile

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FP-045Experimental Treatment1 Intervention

The study will enroll a total of 6 young adult/adolescent patients progressing through three dose levels, followed by a minimum of 8 and up to 12 pediatric patients progressing through up to three dose levels.

0 / 10Eligibility criteria met