Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Taxane

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.

Epidiferphane

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.

Taxane Chemotherapy

Coy Heldermon, MD, PhD

Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called relative dose intensity) of these chemotherapy agents in 15-80 % of patients on these drugs. This reduction in relative dose intensity (RDI) results in worse clinical outcomes such as progression free and overall survival. Pre-clinical studies in mouse models subjected to standardized chemotherapy regimens containing paclitaxel or oxaliplatin have shown that the nutritional supplement Epidiferphane™ reduces both neuropathy and anemia. This study will investigate whether the use of Epidiferphane™ in patients with breast cancer receiving taxane chemotherapy results in an attenuation of the side effects experienced, as well as an improvement in tumor response rate. The safety and maximum tolerated dose of Epidiferphane™ in this patient population will also be determined in this study.

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

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.

This will be assessed by the rate of occurrence of DLTs by Epidiferphane dose level

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.

The C24 hours of each of Epidiferphane's components will be based on blood concentration measured 24 hours after taxane chemotherapy administration.

The C24 hours of the taxanes given will be based on blood concentration measured 24 hours after taxane chemotherapy administration.

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").

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").

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I/IIa Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients	NCT03611985	Breast Cancer	Epidiferphane Taxane Chemothe...	18 Years - 99 Years	University of Florida
Phase I/IIa Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients	NCT03611985	Breast Cancer	Epidiferphane Taxane Chemothe...	18 Years - 99 Years	University of Florida

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