Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Carcinoma

Prostatic Neoplasms

Neoplasm Metastasis

Breast Neoplasms

Hyperparathyroidism

Hyperparathyroidism, Secondary

Bone Neoplasms

Hypocalcemia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Parathyroid Diseases

Endocrine System Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

Bone Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Micronutrients

Vitamins

Hormones

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Zoledronic Acid

Denosumab

Calcifediol

Parathyroid Hormone

Trace Elements

Vitamin D3

Calciferol

CTAP101 Capsules

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.

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

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

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.

OPKO Health, Inc.

Rare Diseases

Kidney Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Kidney Failure, Chronic

Vitamin D Deficiency

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Chronic Disease

Disease Attributes

Neoplastic Processes

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Chronic Graft Versus Host Disease

Vasoconstrictor Agents

Calcitriol

1 alpha-hydroxyergocalciferol

CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks

CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks

CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks

CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks

At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily

At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily

At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily

Doxercalciferol

At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily

Paricalcitol

Joel Melnick, MD

This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in stage 3 or 4 chronic kidney disease patients.

Only subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 are eligible to participate in this extension study. This is a phase 3, open-label study of CTAP101 Capsules, with and without add-on vitamin D hormone therapy.

Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

A Long-term Safety and Efficacy Study of CTAP101 Capsules in Subjects With Stages 3 or 4 Chronic Kidney Disease, Secondary Hyperparathyroidism and Vitamin D Insufficiency (Extension of Study CTAP101-CL-3001 or CTAP101-CL-3002)

Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders

Number of subjects in the per protocol population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders

Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D \>/= 30 ng/mL at End of Treatment (EOT)

Number of Participants in the per protocol population with serum 25-hydroxyvitamin D \>/= 30 ng/mL at End of Treatment (EOT)

CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.

CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.

CTAP101 Capsules (Not Randomized; 6 Mos Treatment)

CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.

CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily

CTAP101 Capsules (Not Randomized; 12 Mos Treatment)

CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.

CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive

CTAP101 Capsules (Monotherapy; 12 Mos Treatment)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Intent to treat population: includes subjects receiving CTAP101 capsules only in the extension trial (up to 6 months total active therapy, subjects receiving up to 12 months receiving CTAP101 capsules (6 months in the previous trials and up to 6 months in the extension) with or without being randomized to CTAP101 capsules plus adjunctive therapy.

Douglass Laidlaw, PhD, Vice President, Medical Affairs

CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.

CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.

CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.

CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily

Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)

Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid	NCT02274623	Breast Cancer Prostate Cancer Bone Neoplasms Hypocalcemia Hyperparathyroi...	CTAP101 Capsule...	18 Years -	OPKO Health, Inc.
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002	NCT02282813	Chronic Kidney ... Hyperparathyroi... Vitamin D Defic...	CTAP101 Capsule... Calcitriol Doxercalciferol Paricalcitol	18 Years -	OPKO Health, Inc.
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002	NCT02282813	Chronic Kidney ... Hyperparathyroi... Vitamin D Defic...	CTAP101 Capsule... Calcitriol Doxercalciferol Paricalcitol	18 Years -	OPKO Health, Inc.

Spots Global Cancer Trial Database for ctap101 capsules