Status:
COMPLETED
Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Breast Cancer
Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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 den...
Eligibility Criteria
Inclusion
- Be diagnosed with bone metastases subsequent to breast (female subjects only) or prostate carcinoma, and will have received zoledronate or denosumab therapy for at least 3 months at the time of enrollment
- Be at least 18 years of age
- Have a life expectancy \>12 months from the anticipated time of initiation of treatment
- Serum calcium \<9.8 mg/dL
- Plasma iPTH ≥70 pg/mL if taking \<1200 IU vitamin D
- Estimated glomerular filtration rate (GFR) \>15 mL/min/1.73m2
- If taking more than 1000 mg/day of elemental calcium, must be willing and able to discontinue or reduce their calcium use and/or use non-calcium based therapies for the duration of the study
- Subjects receiving ≤2000 IU/day vitamin D (ergocalciferol or cholecalciferol) therapy must remain on a stable dose during the study. If taking more than 2000 IU/day of vitamin D (ergocalciferol or cholecalciferol), must be willing and able to reduce use to ≤2000 IU/day and remain on a stable dose for the duration of the study
- Is willing and able to comply with study instructions and commit to all clinic visits for the duration of the study
- Female subject of childbearing potential is neither pregnant nor lactating and must have a negative pregnancy test at the screen visit and a negative pregnancy test before dosing. All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device (IUD), sexual abstinence, vasectomy or vasectomized partner) for the duration of the study
- Has the ability to read and understand subject Informed Consent Form (ICF).
Exclusion
- Spot urine Ca:Cr ratio \>0.25 (\>250 mg/g creatinine)
- Known previous or concomitant serious illness (other than advanced cancer with metastatic bone disease) or medical condition, such as, HIV, significant gastrointestinal disease, or cardiovascular event that in the opinion of the investigator may worsen and/or interfere with participation in the study
- History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any other reason, which in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely
- Known or suspected hypersensitivity to any of the constituents of the investigational product
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02274623
Start Date
December 1 2014
End Date
March 17 2017
Last Update
September 27 2019
Active Locations (6)
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1
Coast Hematology-Oncology Associates
Long Beach, California, United States, 90806
2
Mount Sinai Medical Center, Comprehensive Cancer Center
Miami, Florida, United States, 33140
3
Research by Design LLC
Evergreen Park, Illinois, United States, 60805
4
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263