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Phase I Trial of 225Ac-J591 in Patients With mCRPC

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ClinicalTrials.gov Identifier: NCT03276572
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : March 3, 2020
Sponsor:
Collaborators:
Prostate Cancer Foundation
United States Department of Defense
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
This is an open-label, single-center Phase I dose escalation study designed to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of 225Ac-J591 in a single dose regimen.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 225Ac-J591 Phase 1

Detailed Description:

This clinical trial is for men with advanced prostate cancer. The purpose of this study is to find the highest dose level of the study drug, 225Ac-J591 that can be given without severe side effects. The research study is being done because the standard treatments for prostate cancer that has spread beyond the prostate gland are intended to minimize the adverse effects of the disease. These treatments, however, are not curative. Patients who choose to participate in this study will have a screening visit to determine whether or not they are eligible to participate in the study. The treatment phase is comprised of 8 visits over approximately 12 weeks. The study medication is called 225Ac-J591, and participants will receive an infusion of the study drug on the Treatment visit of the study. Upon completion of investigational treatment with single dose of 225Ac-J591, subjects will undergo 68Ga-PSMA-HBED-CC injection and same day PET/CT at the end of study visit to document treatment response. Subsequently survival data and additional treatment(s) information will be captured from their routine Standard of care (SOC) visits.During the other study visits, participants will undergo routine tests and procedures, such as physical examinations, and routine blood tests. Some blood tests will be done for research purposes only. After completion of therapy, participants may be contacted on a periodic basis to see how they are doing.

Key eligibility:

  • Open to men age 18 and older.
  • Diagnosis of progressive metastatic prostate cancer
  • Have been previously treated for their disease with particular types of therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose-Escalation Trial of 225Ac-J591 in Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: All Subjects
A single dose of 225Ac-J591 will be given to subjects with documented progressive metastatic CRPC.
Drug: 225Ac-J591
225Ac-J591 (13.3 KBq/Kg - 93.3 KBq/Kg or 0.36 uCi/Kg - 2.52 uCi/Kg) on day 1
Other Name: 68Ga-PSMA-HBED-CC injection for PET/CT Scan on day 1 and at end of study




Primary Outcome Measures :
  1. Change in the number of subjects with dose limiting toxicities (DLT) [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]
    DLTs will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

  2. Maximum tolerated dose (MTD) [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]
    The dose that produces an "acceptable" level of toxicity or that, if exceeded, would put subjects at "unacceptable" risk for toxicity. Definition of the MTD usually relies on the sample, as MTD is defined as the dose level at which no more than two patients out of six experienced dose-limiting toxicity (DLT).


Secondary Outcome Measures :
  1. Change in prostate specific antigen (PSA) response [ Time Frame: Samples will be collected at Screening, Day 1, Day 8, Day 15, Day 29, Day 57, Day 85 then then every 4 weeks for 3 visits ]
    PSA will be analyzed through blood specimen collection

  2. Change in circulating tumor cells (CTC) response [ Time Frame: Samples will be collected at Screening, Day 1 and Day 85 visit then every 4 weeks for 3 visits ]
    CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing

  3. Change in the number of subjects with radiographic (imaging) response [ Time Frame: Scans will be performed at Screening and Day 85 ]
    Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications

  4. Change in the number of subjects in patient reported outcomes (PRO) through Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire [ Time Frame: Samples will be collected at Screening, Day 1, Day 8, Day 15, Day 29, Day 57, Day 85 then then every 4 weeks for 3 visits ]
    FACT-P questionnaire is a commonly used PRO assessing the health-related quality of life in men with prostate cancer. The FACT-p scale is measured from 0-4

  5. Change in the number of subjects in patient reported outcomes(PRO) through Brief Pain Inventory (BPI) short form [ Time Frame: Samples will be collected at Screening, Day 1, Day 8, Day 15, Day 29, Day 57, Day 85 then then every 4 weeks for 3 visits ]
    BPI is a questionnaire is utilized to assess the severity of pain and the impact it has on daily functioning. The scale is based on a rating of 0-10

  6. Change in Biochemical and radiographic progression-free survival (PFS) [ Time Frame: Scans will be captured at Screening and Day 85 then every 4 weeks for 3 visits then every 6 months for 3 years ]
    Radiographic evaluation will include bone scan, CT/MRI of abdomen/pelvis, and Chest x-ray (waived if CT/MRI includes chest). Prostate Cancer Working Group 3(PCWG3) modification will be utilized

  7. Overall survival (OS) following single dose of 225Ac-J591 [ Time Frame: Survival will be collected from Day1 through study completion up to 100 months ]
    Overall survival will be captured through in-clinic or telephone contact with subjects



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adult male patients of >18 years age with documented progressive metastatic CRPC
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of prostate
  2. Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria:

    1. PSA progression
    2. Objective radiographic progression in soft tissue
    3. New bone lesions
  3. ECOG performance status of 0-2
  4. Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy.
  5. Have previously been treated with at least one of the following:

    1. Androgen receptor signaling inhibitor (such as enzalutamide)
    2. CYP 17 inhibitor (such as abiraterone acetate)
  6. Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.
  7. Age > 18 years
  8. Patients must have normal organ and marrow function as defined below:

    1. Absolute neutrophil count >2,000 cells/mm3
    2. Hemoglobin ≥9 g/dL
    3. Platelet count >150,000 x 109/microliter
    4. Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault
    5. Serum total bilirubin <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal
    6. Serum AST and ALT <3 x ULN in absence of liver metastases; <5x ULN if due to liver metastases (in both circumstances, bilirubin must meet entry criteria)
  9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Implantation of investigational medical device ≤4 weeks of Cycle 1, Day 1 or current enrollment in oncologic investigational drug or device study
  2. Use of investigational drugs ≤4 weeks or <5 half-lives of Cycle 1, Day 1 or current enrollment in investigational oncology drug or device study
  3. Prior systemic beta-emitting bone-seeking radioisotopes
  4. Known active brain metastases or leptomeningeal disease
  5. History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1
  6. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
  7. Radiation therapy for treatment of PC ≤4 weeks of Day 1 Cycle 1
  8. Patients on stable dose of bisphosphonates or Denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study.
  9. Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 month after last study drug administration
  10. Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse.
  11. Known history of known myelodysplastic syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276572


Contacts
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Contact: GUONC Research Team 212-746-7851 guonc@med.cornell.edu

Locations
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United States, Louisiana
Tulane Cancer Center Clinic Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Patrick Cotogno    504-988-6542    pcotogno@tulane.edu   
Principal Investigator: Alton Sartor, MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: GUONC Research Team       guonc@med.cornell.edu   
Principal Investigator: Scott Tagawa, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Prostate Cancer Foundation
United States Department of Defense
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Scott Tagawa, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03276572    
Other Study ID Numbers: 1706018281
7R01CA207645-03 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases