Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for Advanced or Recurrent Disease

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a dose escalation study to determine the maximum tolerated dose (MTD) and the overall safety and tolerability of a topical compound 31543 (Calcitriol) in patients with metastatic or recurrent cancer who are undergoing chemotherapy with a taxane-based regimen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Berg, LLC
• Treatments: Calcitriol; Taxane

Criteria

Inclusion Criteria:

• Adult patients at least 18 years of age

• Able to fully understand and participate in the informed consent process

• Patients who are scheduled to receive a taxane-based regimen for a histologically confirmed solid tumor that is:

1. Early stage and/or treatment naïve, or

2. Relapsed or is refractory to previous therapy, or

3. Operable and necessitates adjuvant or neo-adjuvant treatment

• Have no evidence of alopecia or mild alopecia (NCI CTCAE grade 1 alopecia defined as hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage). Female/male-pattern baldness or age-related hair loss are allowed if not greater than grade 1, per NCI-CTCAE v. 4.0. Subjects that have previously lost their hair may enroll if they currently have Grade 0 or 1 alopecia

• ECOG Performance Score of 0 or 1 within 14 days prior to registration

• Has baseline neutrophil counts of > 1500 cells/mm3 within 72 hours prior to registration

• Has serum calcium less than or equal to ULN (for patients with an albumin lower than 3.0, a corrected calcium serum calcium = serum calcium +[0.8][3.5-serum albumin]) within 72 hours prior to registration

Exclusion Criteria:

• Patients receiving calcium-lowering therapy or drugs that may affect calcium levels (e.g., calcitonin, mithramycin, phosphate, denosumab) within 4 weeks of initiation of topical calcitriol. Patients who have been managed with bisphosphonates or calcium-lowering therapy for 3 months or greater prior to the start of the trial and have demonstrated evidence for stability of calcium metabolism would be considered eligible for participation in the trial.

• Has a history of drug or alcohol abuse within 1 year of study enrollment as determined by the investigator.

• Patients who elect to shave the scalp hair prior to the initiation of chemotherapy or who plan to do so during the chemotherapy treatment.

• Any dermatological condition that in the opinion of the investigator will affect the absorption of the study medication, e.g. Atopic Dermatitis, etc.

• Has been treated with an investigational agent within 30 days or six half-lives of its biologic activity whichever is longer, before the start of study. (Patients may not be concurrently enrolled on another trial or concurrently treated with another investigational agent)

• Patients with a history of hypercalcemia or vitamin D toxicity, or hospitalization for treatment of angina, myocardial infarction, or congestive heart failure or psychiatric illness currently or within 30 days of study entry as determined by the investigator.

• Has a history of significant allergy to calcitriol as determined by the investigator.

• Has any condition that interferes with the ability of the subject to understand or comply with the requirements of the study.

• Patients taking Vitamin D supplements during the study, unless they have been taking Vitamin D supplements for 30 days or more prior to the start of the study and that the dose of the Vitamin D supplement remain the same throughout the study.

• Patients treated with medications that are known to affect calcium levels within 4 weeks of initiation of topical therapy (>500 IU vitamin A, calcium supplements, fluoride, antiepileptics).with the exception of subjects on stable therapy for more than six months

• Patients receiving thiazides or furosemide diuretics, with the exception of subjects who have stable doses and have been on therapy for over six months

• Patients with hypercalcemia or kidney stones

• Patients that indicate they have significant hair breakage or hair damage and associated hair loss from hair over-processing within the last 30 days due to peroxide applications, permanent hair coloring, bleaches, streaking, perms, relaxers and/or hair oxidative dyes.

• Current alopecia grade 2 or greater as per NCI-CTCAE v.4.0, or significant hair loss or hair breakage

• Prior radiation to the cranium

• Pregnant or breastfeeding