Trial record 3 of 12 for:    alpharadin | Open Studies

A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02034552
First received: December 16, 2013
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

The primary objective in this study is to evaluate bone scan response at Week 24 based on the quantified technetium-99 bone scan lesion area (BSLA). The safety of radium-223 dichloride in combination with abiraterone acetate or enzalutamide will be investigated. The study will evaluate radiological progression free survival, overall survival, and skeletal events. This study will also explore the clinical utility of different imaging modalities (whole body quantified technetium-99 bone scan, DW-MRI and NaF PET-CT scan) and will have a separate central radiological review for applicable secondary and exploratory imaging endpoints. All subjects will be randomized as assigned randomly by the IXRS system in a 1:1:1 ratio into one of the treatment arms: radium-223 dichloride alone, 50 kBq/kg every 4 weeks for up to 6 doses; radium-223 dichloride, 50 kBq/kg every 4 weeks up to 6 doses together with abiraterone acetate 1,000 mg daily and prednisone 5 mg bid; radium-223 dichloride 50kBq/kg every 4 weeks up to 6 doses together with enzalutamide 160 mg daily.The study will consist of screening, treatment and follow-up periods. Study will continue until disease progression as determined by investigator, or when patient meets criteria for withdrawal from study. Subjects in treatment arms with abiraterone/prednisone or enzalutamide will have the option to continue taking oral study therapy until the end of the study (2 years from the last dose of radium-223 dichloride) if the investigator deems the subject may benefit and there is no clinical or radiological progression. Subjects who discontinue all study treatment prior to 2 years from last radium-223 dichloride treatment will enter active follow-up. During the active follow-up period, the subject will have a safety visit at the clinic every 12 weeks from the EOT for up to 2 years from the last dose of radium-223 dichloride. Beyond 2 years from last radium-223 dichloride treatment,subjects will enter long-term follow-up and will be followed via phone contact at intervals to assess for safety (hematological toxicity and new primary malignancies) and overall survival. A separate long-term safety follow-up study protocol is planned. Once implemented, the study subjects surviving after the end of the active follow-up will be transitioned to this separate long-term safety follow-up protocol.


Condition Intervention Phase
Prostatic Neoplasms
Drug: Radium-223 dichloride (Xofigo,BAY88-8223)
Drug: Abiraterone acetate
Drug: Prednisone
Drug: Enzalutamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open-label Phase IIa Study Evaluating Quantified Bone Scan Response Following Treatment With Radium-223 Dichloride Alone or in Combination With Abiraterone Acetate or Enzalutamide in Subjects With Castration-resistant Prostate Cancer Who Have Bone Metastases

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Patient Bone Scan Response [ Time Frame: At 24 weeks ] [ Designated as safety issue: No ]
    Radiological bone scan response based on change from baseline of digitized technetium-99 bone scans using computer-aided detection software


Secondary Outcome Measures:
  • radiological progression-free survival (rPFS) [ Time Frame: from randomization to radiological disease progression or death from any cause, up to 30 months ] [ Designated as safety issue: No ]
  • symptomatic skeletal event-free survival (SSE-FS) [ Time Frame: From randomization to the earlier SSE or death, up to 30 months ] [ Designated as safety issue: No ]
  • Time to first symptomatic skeletal event(SSE) [ Time Frame: From randomization to first SSE or death, up to 30 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: From randomization to the date of radiological disease progression, up to 7.5 years ] [ Designated as safety issue: No ]
  • time to radiological bone progression by treatment group [ Time Frame: time to radiological bone progression up to 30 months ] [ Designated as safety issue: No ]
  • Number of participants with treatment-emergent adverse events as a measure of safety and tolerability [ Time Frame: Up to 30 months ] [ Designated as safety issue: Yes ]
  • Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Up to 7.5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: December 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radium-223 dichloride(Xofigo, BAY88-8223) Drug: Radium-223 dichloride (Xofigo,BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg every 4 weeks x 6 doses intravenous injection (slow bolus)
Experimental: Radium-223 with abiraterone&prednision Drug: Radium-223 dichloride (Xofigo,BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg every 4 weeks x 6 doses intravenous injection (slow bolus)
Drug: Abiraterone acetate
Abiraterone acetate 1000 mg (4 x 250 mg tablets) taken orally once daily
Drug: Prednisone
Prednisone 5 mg capsule taken orally twice daily
Experimental: Radium-223 with enzalutamide Drug: Radium-223 dichloride (Xofigo,BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg every 4 weeks x 6 doses intravenous injection (slow bolus)
Drug: Enzalutamide
Enzalutamide 160 mg (4 x 40 mg tablets) taken orally once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Known castration-resistant disease
  • Serum PSA ≥2 ng/mL (μg/L)
  • Multiple skeletal metastases (≥2 hot spots) on bone scan
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
  • Life expectancy ≥6 months
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • History of visceral metastasis, or visceral metastases
  • Malignant lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
  • Medical condition that would make prednisone (corticosteroid) use contraindicated
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone bid
  • Treatment with more than one chemotherapy agent for prostate cancer
  • Prior systemic radiotherapy and hemibody external radiotherapy
  • History of pituitary or adrenal dysfunction
  • Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget's disease of bone)
  • Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
  • History of seizures (taking/not taking anticonvulsants), arteriovenous malformation in the brain, head trauma with loss of consciousness
  • Central nervous system (CNS) metastases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034552

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 24 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02034552     History of Changes
Other Study ID Numbers: 16544
Study First Received: December 16, 2013
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Succinylcholine
Prednisone
Radium Ra 223 dichloride
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014