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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01223 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA069533 | U.S. NIH Grant/Contract | View source |
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After enrollment of the first 3 subjects, an interim assessment was conducted. Comparing DBS sampling to plasma PK levels yielded unconvincing results.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized pilot phase I trial studies the side effects of dietary fat levels and abiraterone acetate uptake in patients with metastatic hormone-resistant prostate cancer. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Eating a low or high fat diet may increase the uptake of abiraterone acetate.
PRIMARY OBJECTIVES:
I. To assess the dietary effects of a low fat and high fat diet at a low abiraterone acetate dose (250 mg) on drug levels compared to standard dose administered in a fasting condition.
SECONDARY OBJECTIVES:
I. To potentially guide decisions in the future to use low dose abiraterone in a fed state and decrease overall cost.
II. To evaluate the potential relationship between esterase activity and abiraterone metabolism in an exploratory analysis.
III. To determine the feasibility of using patient-collected dried blood spot (DBS) samples for pharmacokinetic monitoring.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard dose abiraterone acetate orally (PO) once daily (QD) (held on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients eat a low fat breakfast on day 3 and a high fat breakfast on day 10.
ARM II: Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (abiraterone acetate, low then high fat breakfast) | Experimental | Patients receive standard dose abiraterone acetate PO QD (held on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients eat a low fat breakfast on day 3 and a high fat breakfast on day 10. |
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| Arm II (abiraterone acetate, high then low fat breakfast) | Experimental | Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abiraterone acetate | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC)0-24 measurement | The cross-over difference (log[AUC0-24(low fat)] - log[AUC0-24(high fat)]) of each patient will be computed and graphically illustrated. The cross-over difference will be estimated and reported with 95% confidence interval. Hills-Armitage approach will be used to adjust for the period effect for the estimation. In addition, a bioequivalence range will be computed for the log(AUC0-24[1000 mg with fasting food]), allowing for 20% differences in each side. | Up to 24 hours (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of patient-collected DBS sampling technique | The first three patients enrolled will have duplicate venous blood samples obtained in clinic 2 hours post-dose for in vivo confirmation of the DBS methodology. | Day 3 |
| Patient adherence to pre-defined sampling schedule |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Beer | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| dietary intervention | Dietary Supplement | Receive low fat breakfast |
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| dietary intervention | Dietary Supplement | Receive high fat breakfast |
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| pharmacological study | Other | Correlative studies |
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| questionnaire administration | Other | Ancillary studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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Patients will document the date/time of drug administration and the date/time of sample collection using a drug and DBS sample diary. Deviations greater than 10% of the shorter of the two time intervals surrounding the pre-defined time point will be considered non-adherent. Adherence rates will be compared for different time points. |
| Up to day 14 |
| Patient satisfaction of DBS method, measured using the Patient Questionnaire of DBS Sampling Method | Paired t-test will be conducted to compare the DBC (or transformed DBC) for the evaluation of carry-over effect. | Day 14 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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