Clinical trial · Interventional
AFP464 in Treating Patients With Advanced Solid Tumors
A Phase 1 Study of AFP464 (Aminoflavone Prodrug) in Patients With Advanced Solid Tumors
NCT00369200CI-TRIAL-00012944terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial is studying the side effects and best dose of AFP464 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as AFP464, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AFP464 | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive AFP464 IV over 3 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 2-6 patients receive escalating doses of AFP464 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which ≤ 1 of 6 patients experience dose-limiting toxicity. An additional 10 patients whose tumor is amenable to biopsy are treated at the MTD. Patients undergo blood collection periodically for pharmacokinetic and pharmacodynamic studies. Patients treated at the MTD also undergo tumor tissue biopsies periodically for additional pharmacodynamic and correlative biomarker studies. After completion of study treatment, patients are followed for 4 weeks.
- interventionNames
- Drug: AFP464
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (2)
- measure
- Maximum tolerated dose determined by dose-limiting toxicity
- timeFrame
- 28 days
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Bilirubin normal * Platelet count \>= 100,000/mm³ * AST and ALT =\< 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance \>= 60 mL/min * Adequate pulmonary function * DLCO =\< grade 1 * No symptomatic pulmonary disease * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test * No history of allergic reactions attributed to compounds of similar chemical or biological composition to AFP464 * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would limit study compliance * No smoking within the past 30 days; must be willing and able to completely refrain from smoking during study participation * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin C, or bleomycin) and recovered * At least 4 weeks since prior radiotherapy; no prior thoracic radiotherapy; no prior radiotherapy to \>= 50% of total marrow volume * More than 4 weeks since prior experimental therapy (non-FDA-approved agents), immunotherapy, or targeted agents and recovered * More than 8 weeks since prior UCN-01 * More than 2 weeks since prior hormonal therapy except for patients on androgen suppression for prostate cancer * Concurrent androgen suppression allowed in patients with prostate cancer * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * Histologically confirmed malignant solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * Tumor amenable to biopsy (maximum tolerated dose expansion cohort) * No known brain metastases * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy \> 12 weeks * Absolute neutrophil count \>= 1,500/mm³ * No other concurrent anticancer agents or therapies * Renal cell cancer, breast cancer, and non-small cell lung cancer encouraged
References
Publications (0)
Data not yet available
No reference posted for this study.