This is an open-label exploratory study of CTAP101 Capsules in patients with bone metastases arising from either breast or prostate cancer, who are taking anti-resorptive therapy.
This is a multi-center, open-label, repeat-dose study to evaluate the safety, efficacy, and tolerability of CTAP101 Capsules in subjects with bone metastases who are receiving ongoing therapy with denosumab or zoledronic acid. Following screening, approximately 12 eligible subjects with breast cancer and approximately 12 eligible subjects with prostate cancer, all of whom have metastases to bone and are undergoing treatment with anti-resorptive therapies, will receive CTAP101 Capsules at an initial daily oral dose of 30 μg (1 capsule) for 4 weeks. The daily dose may be increased in 30 μg (1 capsule) increments at 4-week intervals to a maximum of 300 μg or until serum calcium reaches \>10.3 mg/dL for two consecutive visits (dose escalation phase) at which time the subject will suspend dosing until serum calcium is ≤10.0 mg/dL and will directly enter a 12-week maintenance phase, resuming treatment at a reduced daily dose, followed by a 2-week follow-up period. Subjects reaching the maximum dose without serum calcium reaching \>10.3 mg/dL, will directly enter the 12-week maintenance phase, followed by a 2-week follow-up period. Serum markers for monitoring bone metabolism (including plasma iPTH, PTHrP, and serum free calcifediol), immune function and tumor burden will be measured during the treatment period. The FACT-BP Quality of Life Measurement in Patients with Bone Pain questionnaire will be used to explore the effect of the treatment, if any, on musculoskeletal pain. The genotype of vitamin D binding protein (DBP) will also be determined. Safety will be monitored through adverse events, serum and urine chemistries, hematology, and ECGs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
33
escalating doses
Coast Hematology-Oncology Associates
Long Beach, California, United States
Mount Sinai Medical Center, Comprehensive Cancer Center
Miami, Florida, United States
Research by Design LLC
Evergreen Park, Illinois, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Effect of repeated, escalating doses of CTAP101 on serum calcium and plasma iPTH levels
Time frame: up to 52 weeks
Effect of repeated, escalating daily doses of CTAP101 on serum calcifediol
Time frame: up to 52 weeks
Safety and tolerability of CTAP101
Measured by the number of participants with treatment related adverse events and abnormal physical examinations, vital signs, clinical laboratory tests (hematology, coagulation, and clinical chemistry, urine calcium, albumin and creatinine), and 12-lead ECG.
Time frame: up to 52 weeks
Effect of repeated, escalating daily doses of CTAP101 on vitamin d metabolites
Time frame: up to 52 weeks
Effect of repeated, escalating doses of CTAP101 on serum phosphorus and spot urine calcium:creatinine ratio
Time frame: up to 52 weeks
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University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Inova Dwight and Martha Schar Cancer Center
Fairfax, Virginia, United States