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

NCT02274623 | Completed Phase 1

• 1 other identifier: CTAP101-CL-1017
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer; Prostate Cancer; Bone Neoplasms; Hypocalcemia; Hyperparathyroidism, Secondary

Keywords

Bone Neoplasms; Hypocalcemia; Hyperparathyroidism, Secondary

Outcome Measures

Primary Outcomes (3)

• Effect of repeated, escalating doses of CTAP101 on serum calcium and plasma iPTH levels

  up to 52 weeks

• Effect of repeated, escalating daily doses of CTAP101 on serum calcifediol

  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.

  up to 52 weeks

Secondary Outcomes (2)

• Effect of repeated, escalating daily doses of CTAP101 on vitamin d metabolites

  up to 52 weeks

• Effect of repeated, escalating doses of CTAP101 on serum phosphorus and spot urine calcium:creatinine ratio

  up to 52 weeks

Study Arms (1)

CTAP101 Capsules

EXPERIMENTAL

CTAP101 Capsules daily

Drug: CTAP101 Capsules

Interventions

CTAP101 Capsules DRUG

escalating doses

Also known as: calcifediol

CTAP101 Capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (6)

Coast Hematology-Oncology Associates

Long Beach, California, 90806, United States

Location

Mount Sinai Medical Center, Comprehensive Cancer Center

Miami, Florida, 33140, United States

Location

Research by Design LLC

Evergreen Park, Illinois, 60805, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

Location

Inova Dwight and Martha Schar Cancer Center

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Bone Neoplasms; Hypocalcemia; Hyperparathyroidism, Secondary

Interventions

Calcifediol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: December 1, 2014
• Primary Completion: February 27, 2017
• Study Completion: March 17, 2017
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

US (6)