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Trial record 3 of 24 for:    alpharadin | Recruiting, Not yet recruiting, Available Studies

Radium Ra 223 Dichloride and Niraparib in Treating Patients With Hormone- Resistant Prostate Cancer Metastatic to the Bone

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2017 by Thomas Jefferson University
Sponsor:
Collaborators:
Janssen, LP
Prostate Cancer Clinical Trials Consortium
Bayer
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT03076203
First received: February 21, 2017
Last updated: May 17, 2017
Last verified: May 2017
  Purpose
This phase Ib trial studies the side effects and best dose of niraparib when given together with radium Ra223 dichloride in treating patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels and has spread from the primary site to the bone. Radium Ra 223 dichloride, acts like calcium to target cancer in the bones and may deliver radiation directly to the bone tumors, limiting damage to the surrounding normal tissue. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radium Ra 223 dichloride and niraparib may work better in treating patients with hormone-resistant prostate cancer metastatic to the bone.

Condition Intervention Phase
Prostate Carcinoma Metastatic to the Bone Stage IV Prostate Adenocarcinoma Hormone-refractory Prostate Cancer Drug: Niraparib Radiation: Radium Ra 223 Dichloride Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (RAPARP)

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Maximum tolerated dose of niraparib to combine with radium Ra 223 dichloride based on dose limiting toxicities graded by National Cancer Institute, Common Toxicity Criteria, version 4.0 [ Time Frame: 12 weeks ]
    There will be three dose levels of niraparib combined with standard doses of Radium 223 to be evaluated for safety


Estimated Enrollment: 6
Anticipated Study Start Date: May 2017
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (niraparib, radium Ra 223 dichloride)
Patients receive niraparib orally daily and radium Ra 223 dichloride IV over 1 minute every 4 weeks. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Niraparib
Given orally
Other Names:
  • MK4827
  • MK-4827
Radiation: Radium Ra 223 Dichloride
Given intravenously
Other Names:
  • BAY 88-8223
  • Radium 223 Dichloride
  • RADIUM CHLORIDE RA-223
  • Xofigo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic diagnosis of adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Bone metastases
  • Documented progressive metastatic CRPC based on at least one of the following criteria:

    • PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL
    • Soft-tissue progression defined as an increase >= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions or the appearance of new lesions
    • Documented appearance of new lesions by bone scan
  • Agree to undergo a tumor/bone marrow biopsy of at least one metastatic site
  • Have adequate archival prostate cancer tissue for DNA analysis
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Testosterone =< 50 ng/dL; patients must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy
  • Patients on long term (>= 6 months) first generation anti-androgen therapy (e.g. flutamide, bicalutamide, nilutamide) will need to discontinue anti-androgen therapy for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen; patients that have been on a first generation anti-androgen 6 months or less will need to discontinue therapy prior to registration (no wash out period required)
  • Patients on second generation anti-androgen therapy (enzalutamide) or androgen bio-synthesis inhibitor (abiraterone acetate) will need to discontinue therapy 2 weeks prior to registration (wash out period)
  • Patients on treatment with chemotherapy or any investigational therapeutic agent will need to discontinue therapy 4 weeks prior to registration (wash out period)
  • Absolute neutrophil count (ANC) >= 1,500/uL
  • Hemoglobin >= 10 g/dL
  • Platelet count >= 150,000/uL
  • Creatinine =< 1.5 x the institutional ULN
  • Potassium > 3.5 mmol/L (within institutional normal range)
  • Bilirubin =< 1.5 ULN (unless documented Gilbert's disease)
  • Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) =< 2.5 x ULN
  • Serum glutamate pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =< 2.5 x ULN
  • Men must agree to use adequate contraception prior to study entry, for the duration of study participation and for at least 6 months after last radium 223 dose
  • Must be able to take oral medication without crushing, dissolving or chewing capsules
  • May have received prior radiation therapy or surgery; however, at least 21 days must have elapsed since completion of radiation therapy or surgery and patient must have recovered from all side effects at the time of registration
  • Ability to understand and the willingness to sign a written informed consent document that is approved by the local institutional review board
  • Patients receiving prednisone or steroids must continue on the same dose they were receiving at the time of screening

Exclusion Criteria:

  • Concurrent treatment with any other investigational therapeutic agents
  • More than one prior line of chemotherapy
  • More than one prior line of therapy with a second generation anti-androgen (enzalutamide, ARN-509, etc.) or androgen bio-synthesis inhibitor (abiraterone acetate, TAK 700, etc.); patient may have had one second generation anti-androgen or androgen bio-synthesis inhibitor but not both sequentially; patients that have received combination therapy with second generation anti-androgen plus an androgen bio-synthesis inhibitor would be eligible (e.g., enzalutamide plus abiraterone acetate as one line of therapy on a clinical trial)
  • Prior isotope therapy with strontium-89, samarium or RAD223
  • Patients with known symptomatic brain metastases
  • All herbal, alternative and food supplements (i.e. PC-Spes, saw palmetto, St. John's wort, etc.) must be discontinued before registration; patients may continue on a daily multi-vitamin, calcium and vitamin D
  • Pre-planned concurrent cytotoxic chemotherapy, surgery, or radiation therapy during protocol treatment; radiation therapy is not permitted while on study
  • All hormonal-acting agents (including diethylstilbestrol/DES, aldosterone, and spironolactone) must be discontinued before registration; no washout period will be required for any of these agents
  • Initiation of bisphosphonate/denosumab therapy during the study; patients on stable doses of bisphosphonates or the tumor necrosis factor receptor superfamily member 11a, subfamily L (RANK-L) inhibitor, denosumab, which have been started no less than 4 weeks prior to registration, may continue on this medication
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or concurrent medications that alter cardiac conduction
  • Patients with a "currently active" second malignancy other than non-melanoma skin or superficial urothelial cancers are not eligible; patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered without evidence of disease for 2 years
  • Patients with any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  • Patients with known persistent (> 4 weeks) >= grade 2 toxicity from prior cancer therapy
  • Patients with known >= grade 3 hematological toxicity with the last chemotherapy regimen
  • Patients with chronic conditions associated with non-malignant abnormal bone growth (e.g., Paget's disease of bone)
  • Patients who have used any of the following within 4 weeks prior to registration: blood or platelet transfusions, erythropoietin, and biologic response modifiers such as granulocyte macrophage colony-stimulating factor (GM-CSF) or granulocyte colony-stimulating factor (G-CSF)
  • Patients with baseline QT prolongation > 470 msec
  • Patients receiving concomitant medications that prolong corrected QT interval (QTc)
  • Patients with bulky visceral disease defined as > 4 cm
  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: NCT03076203

Contacts
Contact: William Kelly, DO (215) 955-8874 william.kelly@jefferson.edu

Locations
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: William Kelly, DO       william.kelly@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Janssen, LP
Prostate Cancer Clinical Trials Consortium
Bayer
Investigators
Principal Investigator: William Kelly, DO Sidney Kimmel Cancer Center at Thomas Jefferson University
  More Information

Additional Information:
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03076203     History of Changes
Other Study ID Numbers: 16G.085
Study First Received: February 21, 2017
Last Updated: May 17, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Radium Ra 223 dichloride
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Niraparib
Succinylcholine
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017