- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03611985
Phase I/IIa Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients
Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be at least 18 years of age
- Subjects on the phase I portion must have a clinical diagnosis of metastatic breast cancer. Subjects on the phase IIa portion must have a clinical diagnosis of breast cancer of any stage and histology.
- Must be about to start a new chemotherapy treatment regimen containing either paclitaxel given weekly or docetaxel given every 3 weeks at UF Health
- Must continue cancer therapy at UF Health for at least the next three months
- A functioning digestive tract with no obstruction
- Subjects must be willing to avoid regular consumption of green tea for the duration of trial participation.
- Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with all the study-related procedures.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
- Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study.
Exclusion Criteria:
- Must not be receiving any other investigational agents
- Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and following completion of taxane therapy for an additional 6 months for women of child bearing potential and 3 months for men with partners of child bearing potential.
- Females who are pregnant or breastfeeding
- Active systemic infection considered to be opportunistic, life threatening or clinically significant at the time of treatment.
- Psychiatric illness or social situation that would limit compliance with trial requirements.
- Known allergy to turmeric, broccoli, or green tea.
- Subjects must not be on treatment with verapamil or tacrolimus during the trial.
- History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding (e.g. hemoglobin < 10 mg/dL, CTCAE v 5.0 grade 3 or higher neutropenia or thrombocytopenia) giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
- CTCAE v 5.0 grade 2 or higher peripheral sensory or motor neuropathy
- CTCAE v 5.0 grade 1 or higher paresthesia
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >2.5 × the upper limit of normal (ULN)
- Total bilirubin (TBL) >1.5 × ULN or >3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia)
- Glomerular filtration rate (GFR) <50 mL/min
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Epidiferphane + taxane chemotherapy
|
During the phase I portion of the study, subjects will be assigned to take either two (half target dose) or four (full target dose) Epidiferphane tablets orally three times daily following a 3 + 3 design. Three subjects will be sequentially enrolled at each of the 2 dose levels (beginning with the half target dose) until at least one dose-limiting toxicity (DLT) occurs. Dosing escalation will be stopped if two or more DLTs occur at either dose level. The maximum tolerated dose will be one dose level lower than the dose level at which 2 or more DLTs occur. Dose escalation will occur separately for each of the two taxane regimens (weekly paclitaxel or docetaxel every 3 weeks). All subjects in the phase IIa portion of the study will receive the maximum tolerated dose determined in the phase I portion of the study for their taxane regimen. Subjects in both portions of the study will receive treatment with Epidiferphane for a maximum of three months.
All subjects on both phases of the study will be concurrently treated with a taxane regimen containing either paclitaxel given weekly or docetaxel given every 3 weeks.
The choice of taxane regimen will be determined by the treating physician prior to consenting to participate in this trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration at 24 hours (C24 hours) of Epidiferphane's components
Time Frame: 24 hours
|
The C24 hours of each of Epidiferphane's components will be based on blood concentration measured 24 hours after taxane chemotherapy administration.
|
24 hours
|
Concentration at 24 hours (C24 hours) of taxanes
Time Frame: 24 hours
|
The C24 hours of the taxanes given will be based on blood concentration measured 24 hours after taxane chemotherapy administration.
|
24 hours
|
Cmax of Epidiferphane's components
Time Frame: 24 hours
|
The Cmax of each of Epidiferphane's components will be based on blood concentration measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration.
|
24 hours
|
Rate of occurrence of DLTs by dose level in patients with breast cancer who are being treated with taxanes
Time Frame: 4 months
|
This will be assessed by the rate of occurrence of DLTs by Epidiferphane dose level
|
4 months
|
Maximum tolerated dose of Epidiferphane in patients with breast cancer who are being treated with taxanes
Time Frame: 3 months
|
3 months
|
|
Cmax of taxanes
Time Frame: 3 weeks
|
The Cmax of the taxane chemotherapy agents given will be based on blood concentrations measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration.
|
3 weeks
|
Number of adverse events (graded according to CTCAE v5.0 criteria) by epidiferphane dose level
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Epidiferphane on quality of life, as measured by the EORTC QLQ-C30 scale
Time Frame: 3 months
|
The EORTC QLQ-C30 measures ability to perform everyday activities and whether the subject has experienced select physical symptoms on a scale of 1-4 (with 1 meaning "Not at all" and 4 meaning "Very much"), as well as overall quality of life and overall healt over the past week on a scale from 1-7 (with 1 meaning "Very Poor" and 7 meaning "Excellent").
|
3 months
|
Effect of Epidiferphane on quality of life, as measured by the FACT-Taxane scale
Time Frame: 3 months
|
The FACT-Taxane measures various aspects of physical, social, emotional, and functional well-being, as well as whether the subject has experienced select physical symptoms over the past 7 days, on a scale of 0-4 (with 0 meaning "Not at all" and 4 meaning "Very much").
|
3 months
|
Change in CTCAE grade 2 or higher neuropathy and anemia, as compared to historically reported rates for the occurrence of each of these events
Time Frame: 4 months
|
4 months
|
|
Effect of Epidiferphane on tumor response rate, as measured by RECIST 1.1 criteria and pathologic tumor response at surgery
Time Frame: 3 months
|
3 months
|
|
Effect of Epidiferphane on the neuropathy marker NF-kB, as measured by multiplex cytokine bead analysis
Time Frame: 3 weeks
|
3 weeks
|
|
Effect of Epidiferphane on the neuropathy marker VEGFA, as measured by multiplex cytokine bead analysis
Time Frame: 3 weeks
|
3 weeks
|
|
Effect of Epidiferphane on the neuropathy marker Nrf2, as measured by multiplex cytokine bead analysis
Time Frame: 3 weeks
|
3 weeks
|
|
Effect of Epidiferphane on the neuropathy marker IL18, as measured by multiplex cytokine bead analysis
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Coy Heldermon, MD, PhD, University of Florida
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF-BRE-002
- IRB201800973 -A (OTHER: University of Florida)
- OCR16043 (OTHER: University of Florida)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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