Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Musculoskeletal Diseases

Rare Diseases

Breast Neoplasms

Neoplasm Metastasis

Prostatic Neoplasms

Carcinoma

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms, Second Primary

Bone Neoplasms

Bone Marrow Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Neoplastic Processes

Bone Diseases

Bone Density Conservation Agents

All Drugs and Chemicals

Zoledronic Acid

Denosumab

Diphosphonates

Pamidronate

This is an open-label randomization to receive IV bisphosphonate (administered per package insert) every 4 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will receive AMG 162 180mg (SC) every 4 weeks.

This is an open-label randomization to receive 180 mg AMG 162 (SC) every 12 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 12 weeks.

This is an open-label randomization to receive 180 mg AMG 162 (SC) every 4 weeks during the treatment phase. If subject is enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 4 weeks.

A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses.

AMG 162 180 mg (SC) q 12 weeks

IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses.

IV Bisphosphonate q 4 weeks

A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.

AMG 162- 180 mg q 4 weeks

The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.

Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates

A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates

Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.

Urinary N-telopeptide (uNTX) corrected by creatinine \< 50 nmol/mmol at week 25.

Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.

Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.

Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.

Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.

Time from study day 1 to first Skeletal Related Event (SRE), defined as \>1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

Skeletal Related Event (SRE), defined as \>1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria

Amgen

Global Development Leader

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Bisphosphonate IV Q4W

Denosumab 180 mg Q12W

Denosumab 180 mg Q4W

Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)

Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)

Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)

Total

Age Continuous

Sex: Female, Male

White or Caucasian

Black or African American

Hispanic or Latino

Asian

Native Hawaiian or Other Pacific Islander

Other

Race/Ethnicity, Customized

Breast cancer

Prostate cancer

Mutiple myeloma

Other solid tumor

Cancer Type Stratification Factor

Corrected for urine creatinine (uNTx/Creatinine)

Urinary N-telopeptide (uNTx) Level

Serum C-Telopeptide (CTx)

Study Director

All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.

uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13

uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25

Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25

Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol

Treatment Phase Primary Analysis Subset. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject whose uNTX (corrected by creatinine) less than 50nmol/mmol is presented.

Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol

All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx and had available data.

Percent Change of Serum CTX From Baseline to Week 25

All participants exposed to investigational product during the treatment phase. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject who experienced a skeletal related event is presented.

Time to First Skeletal Related Event

All participants exposed to investigational product during the treatment phase.

Skeletal Related Events

Hypercalcemia

Treatment Period (25 Weeks)

Follow-up Period

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hormones

120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.

amg 162

The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.

Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only

An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.

Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W

This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.

Denosumab 120 mg Q4W / Denosumab 120 mg Q4W

Age, Continuous

Number of Participants Survived

Overall Study

Breast Diseases

Skin Diseases

Antineoplastic Agents

Tamoxifen

Fulvestrant

Aromatase Inhibitors

Radium Ra 223 dichloride

Hormone Antagonists

Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.

Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.

Ra-223 dichloride

120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

Hormone Therapy

Naoto Ueno, MD, PHD

The goal of this clinical research study is to learn if Xofigo® (also called Ra-223 dichloride) combined with hormone therapy and denosumab can help to control breast cancer that has spread to the bones and/or bone marrow. The safety of this study drug combination will also be studied.

This is an investigational study. Denosumab and the hormone therapies used in this study are FDA-approved and commercially available for the treatment of metastatic breast cancer. Ra-223 dichloride is FDA-approved and commercially available for the treatment of bone metastases. It is considered investigational to use the combination of Ra-223 dichloride, hormone therapy and denosumab to treat patients with bone cancer that has spread to the bones.

The study doctor can explain how the study drugs are designed to work.

Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive Ra-223 dichloride by vein over no more than 1 minute on Day 1 of each 28-day study cycle.

You will also receive denosumab as an injection under the skin on Day 1 of Cycles 1- 6.

You will also receive hormone therapy while on study. Your doctor will discuss with you what type of hormone therapy you will have, how it will be given, and its risks.

Study Visits:

On Day 1 of Cycle 1, blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycles 2-5:

* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycle 6:

* Blood (about 2 teaspoons) and urine will be collected for routine tests.
* Blood (about 3 tablespoons) will be drawn for biomarker testing, including genetic biomarkers.
* Blood (about 5 teaspoons) will be drawn to test for CTCs, tumor markers, and genetic testing.
* You will have a PET-CT scan and a bone scan to check the status of the disease. If the doctor thinks it is needed, you will also have an MRI.

Length of Study Participation:

You may continue taking the study drugs for up to 6 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation will be over after the end-of-study visit.

End-of-Study Visit:

After your last dose of study drug:

* You will have a physical exam.
* Blood (about 2 teaspoons) and urine will be collected for routine tests.
* Blood (about 3 tablespoons) will be drawn for biomarker testing, including genetic biomarkers.
* Blood (about 5 teaspoons) will be drawn to test for CTCs, tumor markers, and genetic testing.
* You will have a PET-CT scan and either a bone scan or a CT scan to check the status of the disease. If the doctor thinks it is needed, you will also have an MRI.
* If the doctor thinks it is needed, you will have a bone marrow aspiration/biopsy to check the status of the disease.

Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer

Phase II Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer

Disease control rate is defined as the rate of the patients at that time with clinically complete or partial response or stable disease.

Bayer

M.D. Anderson Cancer Center

Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.

Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.

Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

Ra-223 Dichloride + Denosumab

Age, Categorical

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Dr. Naoto T Ueno, Professor, Breast Medical Oncology

1 patient was lost to FU between 6 and 9 months from first dose of Radium -223

Number of Participants With Disease Control Rate at 9 Months

The Number of Participants With Disease Control Rate at 6 Months

Participants receive a single subcutaneous (SC) administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, in addition to receiving Denosumab every 4 weeks, participants receive a hormonal agent chosen by each physician, excluding the agent that participants received at adjuvant therapy setting.

120 mg subcutaneously on Day 1 of every 28 day cycle.

The goal of this clinical research study is to learn if denosumab in combination with a hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with breast cancer that has spread to the bone. The safety of this combination will also be studied.

This is an investigational study. Denosumab is FDA approved and commercially available to prevent bone-related events caused by breast cancer that has spread to the bone. Using denosumab to lower CTCs in patients with breast cancer that has spread to the bone is investigational.

You may have the option of continuing denosumab after the study ends.

Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive denosumab through a needle under your skin on Day 1 of each 28-day study cycle.

Starting on Day 1 of week 4, you will also begin taking a hormonal drug. The study doctor will choose the hormonal drug you receive based on your previous hormonal therapy for breast cancer. The study doctor will give you instructions for taking your hormonal drug.

Study Visits:

On Day 1 of week 4:

* You will have a physical exam
* Blood (about 3 tablespoons) will be drawn for routine tests
* Blood (about 5 teaspoons) will be drawn for CTC testing and to check your immune system.
* Urine will be collected to test for a biomarker that is used to measure the rate of bone breakdown.
* If the study doctor thinks it is needed, you will have a PET scan, a bone scan, or an MRI to check the status of the disease.

On Day 1 of Cycle 2 and Cycle 3, blood (about 1 teaspoon) will be drawn for routine tests.

Length of Study:

You may receive the denosumab and hormonal therapy combination for up to 13 weeks. You will be taken off study if the disease gets worse or intolerable side effects occur.

End of Study Visit:

After your last dose of the study drug, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 3 tablespoons) will be drawn for routine tests.
* Blood (about 5 teaspoons) will be drawn for CTC testing and to check your immune system.
* Urine will be collected to test for a biomarker that is used to measure the rate of bone breakdown.
* If the study doctor thinks it is needed, you will have a PET scan, a bone scan, or an MRI to check the status of the disease.

Denosumab for Breast Cancer With Bone Mets

Phase II Study of Denosumab to Define the Role of Bone Related Biomarkers in Breast Cancer Bone Metastasis

The difference in number of CTCs in 7.5 ml whole blood from baseline to week4. CTC reduction from baseline to week4 is statistically analyzed using the two-sided paired t-test with the significance level of 0.05.

The change in Her2, Muc-1, GA733-2 (EpCAM), Twist, Akt, PI3K and ALDH-1 in CTCs after 1 st cycle of treatment with denosumab.

The collection urine is performed at baseline, at week4 and the end of 3rd cycle (week13) to evaluate the level of N-telopeptide.

A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.

Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Ueno,Naoto,M.D., PH.D. / Breast Medical Oncology

The primary objective could not be met due to technical issues.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates	NCT00104650	Bone Metastases... Bone Metastases... Bone Metastases...	AMG 162 180 mg ... IV Bisphosphona... AMG 162- 180 mg...	18 Years -	Amgen
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only	NCT00950911	Bone Metastases... Bone Metastases... Bone Metastases...	amg 162	18 Years -	Amgen
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates	NCT00104650	Bone Metastases... Bone Metastases... Bone Metastases...	AMG 162 180 mg ... IV Bisphosphona... AMG 162- 180 mg...	18 Years -	Amgen
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only	NCT00950911	Bone Metastases... Bone Metastases... Bone Metastases...	amg 162	18 Years -	Amgen
Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer	NCT02366130	Breast Cancer	Ra-223 dichlori... Denosumab Hormone Therapy	18 Years -	M.D. Anderson Cancer Center
Denosumab for Breast Cancer With Bone Mets	NCT01952054	Breast Cancer	Denosumab	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for amg 162

Every month we try and update this database with for amg 162 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for amg 162

Every month we try and update this database with for amg 162 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for amg 162 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.