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Breast CancerPhase 1/2NCT03611985

Phase I/IIa Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients

A Phase 1/2 study testing Epidiferphane and Taxane Chemotherapy in people with Breast Cancer, run by University of Florida.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Breast Cancer
What is being tested?
Epidiferphane and Taxane Chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2020to Mar 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

About this study

Official title: Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients

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.

Conditions
Breast Cancer
Being tested
Epidiferphane, Taxane Chemotherapy
Keywords
breast cancer, Epidiferphane, taxane
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpidiferphaneDrug

    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.

  • Taxane ChemotherapyDrug

    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.

Study groups in NCT03611985
Study groupRoleWhat they receive
Epidiferphane + taxane chemotherapyExperimentalNot described
Receives: Drug: Epidiferphane; Drug: Taxane Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of Epidiferphane's components

    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.

    Measured: 24 hours

  2. Rate of occurrence of DLTs by dose level in patients with breast cancer who are being treated with taxanes

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

    Measured: 4 months

  3. Maximum tolerated dose of Epidiferphane in patients with breast cancer who are being treated with taxanes

    Measured: 3 months

  4. Cmax of taxanes

    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.

    Measured: 3 weeks

  5. Number of adverse events (graded according to CTCAE v5.0 criteria) by epidiferphane dose level

    Measured: 4 months

  6. Concentration at 24 hours (C24 hours) of Epidiferphane's components

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

    Measured: 24 hours

  7. Concentration at 24 hours (C24 hours) of taxanes

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

    Measured: 24 hours

Secondary outcomes (8)

  1. Change in CTCAE grade 2 or higher neuropathy and anemia, as compared to historically reported rates for the occurrence of each of these events

    Measured: 4 months

  2. Effect of Epidiferphane on tumor response rate, as measured by RECIST 1.1 criteria and pathologic tumor response at surgery

    Measured: 3 months

  3. Effect of Epidiferphane on the neuropathy marker NF-kB, as measured by multiplex cytokine bead analysis

    Measured: 3 weeks

  4. Effect of Epidiferphane on the neuropathy marker VEGFA, as measured by multiplex cytokine bead analysis

    Measured: 3 weeks

  5. Effect of Epidiferphane on the neuropathy marker Nrf2, as measured by multiplex cytokine bead analysis

    Measured: 3 weeks

  6. Effect of Epidiferphane on the neuropathy marker IL18, as measured by multiplex cytokine bead analysis

    Measured: 3 weeks

  7. Effect of Epidiferphane on quality of life, as measured by the EORTC QLQ-C30 scale

    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").

    Measured: 3 months

  8. Effect of Epidiferphane on quality of life, as measured by the FACT-Taxane scale

    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").

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2018
  2. Study startMar 2020 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionMar 2023 (estimated)

Why it stopped: institutional conflict of interest

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03611985
Sponsor's protocol ID
UF-BRE-002
Other IDs
IRB201800973 -A, OCR16043
Status last verified
Jan 2020
First submitted
6 Jul 2018
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Epidiferphane and Taxane Chemotherapy in people with Breast Cancer, run by University of Florida.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of Epidiferphane's components (time frame: 24 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03611985.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

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