Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer P... http://clinicaltrials.gov/ct2/show/NCT01618370?...
Author: Reynold Edwards
7 downloads 1 Views 87KB Size
Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer P...

http://clinicaltrials.gov/ct2/show/NCT01618370?term=2012-000075-16&rank=1

A service of the U.S. National Institutes of Health Trial record 1 of 1 for: Previous Study |

2012-000075-16

Return to List

| Next Study

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases This study is currently recruiting participants.

NCT01618370

Verified December 2013 by Bayer Sponsor:

Bayer Information provided by (Responsible Party): Bayer

Full Text View

Tabular View

ClinicalTrials.gov Identifier:

First received: June 11, 2012 Last updated: December 17, 2013 Last verified: December 2013 History of Changes

No Study Results Posted

Disclaimer

How to Read a Study Record

Purpose This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.

1 von 7

Condition

Intervention

Phase

Prostatic Neoplasms

Drug: Radium-223 dichloride (BAY88-8223)

Phase 3

15.01.2014 09:25

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer P...

http://clinicaltrials.gov/ct2/show/NCT01618370?term=2012-000075-16&rank=1

Study Type: Study Design:

Interventional Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Official Title:

Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Drug Information available for: Succinylcholine chloride Genetic and Rare Diseases Information Center resources: Bone Cancer U.S. FDA Resources Further study details as provided by Bayer:

Primary Outcome Measures: Acute safety, variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: From baseline to 30 days post-treatment ] [ Designated as safety issue: Yes ] Safety variables to be analyzed during the treatment period include: ECOG PS, Skeletal-related events, Treatment emergent Grade 3-4 AEs, any grade of treatment-related AEs and SAEs, Safety laboratory tests including hematology and serum chemistry Long-term safety, variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: From 30 days post-treatment up to 3 years ] [ Designated as safety issue: Yes ] Safety variables to be analyzed during the follow-up period include: Skeletal-related events, Treatment related AEs and SAEs, Secondary malignancies

2 von 7

15.01.2014 09:25

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer P...

http://clinicaltrials.gov/ct2/show/NCT01618370?term=2012-000075-16&rank=1

Secondary Outcome Measures: Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form) [ Time Frame: From baseline up to 1 year ] [ Designated as safety issue: No ] Estimated Enrollment: Study Start Date: Estimated Study Completion Date: Estimated Primary Completion Date:

1500 July 2012 April 2015 April 2015 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Experimental: Radium-223 dichloride

Drug: Radium-223 dichloride (BAY88-8223) One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.

Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers:

18 Years and older Male No

Criteria Inclusion Criteria:

Age ≥18 years of age Histologically or cytologically confirmed prostate cancer Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed) Progressive disease is defined either by: The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), PSA values from 3 assessments within the last 6 months must be provided; OR

3 von 7

15.01.2014 09:25

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer P...

http://clinicaltrials.gov/ct2/show/NCT01618370?term=2012-000075-16&rank=1

In the absence of new bone lesions by 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met) Life expectancy ≥ 6 months Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 2 Adequate hematological, liver, and renal function Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L Platelet count ≥ 100 x10^9/L Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L) Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN Creatinine ≤ 1.5 x ULN Albumin > 25 g/L Exclusion Criteria: Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs (adverse events) due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted) Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer) Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care) Presence of brain metastases

4 von 7

15.01.2014 09:25

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer P...

http://clinicaltrials.gov/ct2/show/NCT01618370?term=2012-000075-16&rank=1

Lymphadenopathy exceeding 6 cm in short-axis diameter Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered. Any other serious illness or medical condition, such as but not limited to: Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2 Cardiac failure New York Heart Association (NYHA) III or IV Crohn's disease or ulcerative colitis Bone marrow dysplasia Fecal incontinence

Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01618370

Contacts

Contact: Bayer Clinical Trials Contact

[email protected]

Show 213 Study Locations Sponsors and Collaborators

Bayer Investigators

Study Director:

Bayer Study Director

Bayer

More Information Additional Information: Click here and search for drug information provided by the FDA.

5 von 7

15.01.2014 09:25

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer P...

http://clinicaltrials.gov/ct2/show/NCT01618370?term=2012-000075-16&rank=1

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. No publications provided Responsible Party: ClinicalTrials.gov Identifier: Other Study ID Numbers: Study First Received: Last Updated: Health Authority:

Bayer NCT01618370 History of Changes 16216, 2012-000075-16 June 11, 2012 December 17, 2013 Belgium: Federal Agency for Medicinal Products and Health Products Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Ireland: Irish Medicines Board Israel: Ministry of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Sweden: Medical Products Agency Denmark: Danish Medicines Agency Norway: Norwegian Medicines Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency Canada: Health Canada France: Agence Nationale de Sécurité du Médicament et des produits de santé Austria: Austrian Federal Office for Safety in Health Care (BASG) Mexico: COmisión FEderal para la Protección contra RIesgos Sanitarios = COFEPRIS Russia: Ministry of Health of Russian Federation

Keywords provided by Bayer: Radium 223 Alpharadin Prostate Cancer

Bone metastases Castrate resistant prostate cancer Hormone refractory prostate cancer

Additional relevant MeSH terms:

6 von 7

15.01.2014 09:25

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer P...

Neoplasms Neoplasm Metastasis Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases

http://clinicaltrials.gov/ct2/show/NCT01618370?term=2012-000075-16&rank=1

Bone Diseases Musculoskeletal Diseases Hematologic Diseases Succinylcholine Hormones Neuromuscular Depolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on January 13, 2014

7 von 7

15.01.2014 09:25

Suggest Documents