AFP464 in Treating Patients With Metastatic or Refractory Solid Tumors That Cannot Be Removed By Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00348699|
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : February 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Male Breast Cancer Recurrent Breast Cancer Recurrent Ovarian Epithelial Cancer Recurrent Primary Peritoneal Cavity Cancer Recurrent Renal Cell Cancer Stage IV Breast Cancer Stage IV Ovarian Epithelial Cancer Stage IV Primary Peritoneal Cavity Cancer Stage IV Renal Cell Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: AFP464 Other: pharmacological study Other: laboratory biomarker analysis||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study and Pharmacological Trial of Once Weekly Aminoflavone Prodrug (AFP464) Administered 3 Out of Every 4 Weeks in Solid Tumor Patients|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||January 2013|
Experimental: Treatment (AFP464)
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.
Other: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
- Maximum tolerated dose, overall toxicity incidence, and toxicity profiles of AFP464 in the treatment of solid tumors [ Time Frame: 28 days ]Measured by dose level and tumor site via the NCI CTCAE v 3.0. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
- Overall response of AFP464 in the treatment of solid tumors [ Time Frame: Up to 3 months ]Measured by Modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Summarized by simple descriptive summary statistics delineating complete and partial responses as well as table and progressive disease in the two patient populations (overall and by tumor group).
- Time to progression [ Time Frame: From registration to documentation of progression, assessed up to 3 months ]Summarized descriptively.
- Time to treatment failure [ Time Frame: From registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months ]Summarized descriptively.
- Urinary excretion of AFP464 [ Time Frame: Days 1-2, 8 and 15 of course 1 ]Examined with descriptive summary statistics and simple graphical tools. Computed and correlated with toxicity and response via Spearman correlation coefficients for continuous variables or Wilcoxon rank sum test if one binary variable is involved.
- Plasma area under the curve (AUC) of AFP464 [ Time Frame: Days 1-2, 8 and 15 of course 1 ]Examined with descriptive summary statistics and simple graphical tools. Computed and correlated with toxicity and response via Spearman correlation coefficients for continuous variables or Wilcoxon rank sum test if one binary variable is involved.
- Percent change in CYP1A1 [ Time Frame: Baseline to 24 hours post AFP-464 ]Computed and investigated with descriptive summary statistics and simple graphical tools. The percent change of CYP1A1 induction will also be correlated with response, toxicity, urinary excretion, and plasma pharmacokinetics measurements. circulating tumor cells (CTC) from all patients will be obtained pre- and post- infusion to determine the inducibility of gene expression of CYP1A1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348699
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Matthew Goetz||Mayo Clinic|