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Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274623
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Bone Neoplasms Hypocalcemia Hyperparathyroidism, Secondary Drug: CTAP101 Capsules Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : December 2014
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : March 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Calcifediol

Arm Intervention/treatment
Experimental: CTAP101 Capsules
CTAP101 Capsules daily
Drug: CTAP101 Capsules
escalating doses
Other Name: calcifediol




Primary Outcome Measures :
  1. Effect of repeated, escalating doses of CTAP101 on serum calcium and plasma iPTH levels [ Time Frame: up to 52 weeks ]
  2. Effect of repeated, escalating daily doses of CTAP101 on serum calcifediol [ Time Frame: up to 52 weeks ]
  3. 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.


Secondary Outcome Measures :
  1. Effect of repeated, escalating daily doses of CTAP101 on vitamin d metabolites [ Time Frame: up to 52 weeks ]
  2. Effect of repeated, escalating doses of CTAP101 on serum phosphorus and spot urine calcium:creatinine ratio [ Time Frame: up to 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274623


Locations
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United States, California
Coast Hematology-Oncology Associates
Long Beach, California, United States, 90806
United States, Florida
Mount Sinai Medical Center, Comprehensive Cancer Center
Miami, Florida, United States, 33140
United States, Illinois
Research by Design LLC
Evergreen Park, Illinois, United States, 60805
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Ohio
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45267
United States, Virginia
Inova Dwight and Martha Schar Cancer Center
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
OPKO Health, Inc.
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Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT02274623    
Other Study ID Numbers: CTAP101-CL-1017
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Keywords provided by OPKO Health, Inc.:
Bone Neoplasms
Hypocalcemia
Hyperparathyroidism, Secondary
Additional relevant MeSH terms:
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Prostatic Neoplasms
Bone Neoplasms
Hypocalcemia
Hyperparathyroidism
Hyperparathyroidism, Secondary
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Bone Diseases
Musculoskeletal Diseases
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents