- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02274623
Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid
September 25, 2019 updated by: OPKO Health, Inc.
Effect of CTAP101 Capsules on Serum Calcium, Plasma Intact Parathyroid Hormone and Vitamin D Metabolites in Patients With Advanced Breast or Prostate Carcinomas With Metastases to Bone and Receiving Ongoing Therapy With Denosumab or Zoledronic Acid
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.
Study Overview
Status
Completed
Intervention / Treatment
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 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
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Long Beach, California, United States, 90806
- Coast Hematology-Oncology Associates
-
-
Florida
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Miami, Florida, United States, 33140
- Mount Sinai Medical Center, Comprehensive Cancer Center
-
-
Illinois
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Evergreen Park, Illinois, United States, 60805
- Research by Design LLC
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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Ohio
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Cincinnati, Ohio, United States, 45267
- University of Cincinnati Cancer Institute
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Virginia
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Fairfax, Virginia, United States, 22031
- Inova Dwight and Martha Schar Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CTAP101 Capsules
CTAP101 Capsules daily
|
escalating doses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of repeated, escalating doses of CTAP101 on serum calcium and plasma iPTH levels
Time Frame: up to 52 weeks
|
up to 52 weeks
|
|
Effect of repeated, escalating daily doses of CTAP101 on serum calcifediol
Time Frame: up to 52 weeks
|
up to 52 weeks
|
|
Safety and tolerability of CTAP101
Time Frame: up to 52 weeks
|
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.
|
up to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of repeated, escalating daily doses of CTAP101 on vitamin d metabolites
Time Frame: up to 52 weeks
|
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
|
up to 52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
February 27, 2017
Study Completion (Actual)
March 17, 2017
Study Registration Dates
First Submitted
October 22, 2014
First Submitted That Met QC Criteria
October 22, 2014
First Posted (Estimate)
October 24, 2014
Study Record Updates
Last Update Posted (Actual)
September 27, 2019
Last Update Submitted That Met QC Criteria
September 25, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Genital Neoplasms, Male
- Prostatic Diseases
- Musculoskeletal Diseases
- Parathyroid Diseases
- Bone Diseases
- Calcium Metabolism Disorders
- Water-Electrolyte Imbalance
- Prostatic Neoplasms
- Hyperparathyroidism
- Bone Neoplasms
- Hyperparathyroidism, Secondary
- Hypocalcemia
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcifediol
Other Study ID Numbers
- CTAP101-CL-1017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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