Completed

A Phase I Study and Pharmacological Trial of Once Weekly Aminoflavone Prodrug (AFP464) Administered 3 Out of Every 4 Weeks in Solid Tumor Patients

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What is being tested

AFP464

+ pharmacological study

+ laboratory biomarker analysis

DrugOther
Who is being recruted

Carcinoma, Ovarian Epithelial+28

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2006
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2006

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of AFP464 in patients with advanced solid tumors. II. Evaluate the toxicity profile of AFP464. III. Characterize the plasma pharmacokinetics and urinary excretion of AFP464 and aminoflavone in these patients. IV. Identify any activity of AFP464 in patients with metastatic cancer. V. Explore whether AFP464 induces cytochrome p450, family 1, member A1 (CYP1A1) expression in tumor (patients enrolled at the MTD) (patients enrolled at the MTD) and/or circulating tumor cells (CTCs) (dose-escalation phase and at the MTD). VI. To explore the relationship between the pharmacogenetic analysis and toxicity or response. OUTLINE: This is a dose-escalation study. Patients receive AFP464 intravenously (IV) over 3 hours on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for up to 3 months.

Official TitleA Phase I Study and Pharmacological Trial of Once Weekly Aminoflavone Prodrug (AFP464) Administered 3 Out of Every 4 Weeks in Solid Tumor Patients
NCT00348699
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Carcinoma, Ovarian EpithelialUrogenital DiseasesGenital DiseasesAdenocarcinomaAdnexal DiseasesBreast DiseasesBreast NeoplasmsCarcinomaCarcinoma, Renal CellEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsSkin DiseasesUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsSkin and Connective Tissue DiseasesBreast Neoplasms, MaleFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

Inclusion Criteria: * Histologic proof of cancer that is now unresectable * Patients with metastatic solid tumors who are refractory to available therapy or for whom standard systemic therapy does not exist * Absolute neutrophil count (ANC) \>= 1500/μL * Platelets (PLT) \>= 100,000/μL * Total bilirubin =\< upper limits of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN * Creatinine =\< 1.25 x ULN; if above 1.25 x ULN calculated creatinine clearance must be \>= 60 ml/min * Hemoglobin (Hgb) \>= 9.0 g/dl * Normal diffusing capacity of the lung for carbon monoxide (DLCO) or the presence of an asymptomatic grade 1 DLCO; NOTE: DLCO must be corrected for hemoglobin * Ability to provide informed consent * Willingness to return to Mayo Clinic for follow-up * Life expectancy \>= 12 weeks * Willingness to provide the biologic specimens (blood and urine) as required by the protocol * COHORT II (MTD) PATIENTS ONLY: * Patients with breast, ovarian, peritoneal or renal cell carcinoma * Tumor that is amenable for biopsy taken during Cycle 1 at 24 +/- 4 hours following the end of AFP-464 infusion * International normalized ratio (INR) =\< 1.4 * Patients taking aspirin: discontinue \>= 5 days prior to procedure * Patients receiving IV Heparin: discontinue 4 hours prior to the procedure and an APTT measurement obtained if clinically indicated * Patients receiving subcutaneous or low molecular weight heparin: discontinue for 8 hours prior to procedure Exclusion Criteria: * Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 3 or 4 * Prior thoracic radiotherapy * Symptomatic pulmonary disease * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements * Any of the following prior therapies: * Chemotherapy =\< 4 weeks prior to study entry * Mitomycin C/nitrosoureas =\< 6 weeks prior to study entry * Immunotherapy =\< 4 weeks prior to study entry * Biologic therapy =\< 4 weeks prior to study entry * Radiation therapy =\< 4 weeks prior to study entry * Radiation to \> 25% of bone marrow * Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment * Uncontrolled brain metastases; Note: Brain metastases are not permitted on study unless the metastases have been treated by surgery or radiotherapy, and the patient has been neurologically stable and off steroids for \>= 4 weeks * Any of the following: * Pregnant women: Females of childbearing potential must have a negative serum pregnancy test =\< 7 days prior to registration * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * History of allergic reactions attributed to compounds of similar chemical or biologic composition to AFP464 * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation) * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy * Active smokers and those who have smoked =\< 30 days prior to registration, and patients unwilling or unable to refrain completely from smoking while on study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive AFP464 IV over 3 hours on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mayo Clinic

Rochester, United StatesOpen Mayo Clinic in Google Maps
CompletedOne Study Center