Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 84 of 103 for:    "Kennedy disease"

ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03300505
Recruitment Status : Not yet recruiting
First Posted : October 3, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of ARRx (also known as AZD5312) plus enzalutamide in patients with metastatic castration resistant prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: ARRx Drug: Enzalutamide Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ARRO-CITO: (UMCC 2017.055) Phase Ib/II Single-Arm Multi-Center Study of IONIS-AR-2.5Rx, a Next Generation Androgen Receptor Antisense Oligonucleotide, in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: ARRx + Enzalutamide

Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.

Phase 2: Subjects will be treated with ARRx (ASO) at the maximum tolerated (MTD), in combination with enzalutamide until clinical or radiologic progression or unacceptable toxicity. (Schedule of administration as in phase 1b.)

Drug: ARRx
Given intravenously (IV)
Other Name: AZD5312

Drug: Enzalutamide
Given by mouth (PO)
Other Name: Xtandi




Primary Outcome Measures :
  1. Number of subjects with dose-limiting toxicity (DLT) during the first cycle of ARRx (in combination with enzalutamide) [ Time Frame: Up to day 21 of treatment ]
    DLTs will be counted based on the number of subjects with DLT at a given dose level. No single subject can trigger more than one DLT event. DLT is defined as any Grade 3 or higher toxicity as defined by CTCAE v5.0. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.

  2. Best overall PSA response [ Time Frame: Up to 36 months (~12 months of treatment and 24 months of follow-up) ]
    Using the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria. From the start of the treatment until disease progression/recurrence.

  3. Percentage of patients with a reduction in PSA of at least 50% from baseline [ Time Frame: Up to ~12 months ]
    Using the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.


Secondary Outcome Measures :
  1. Radiographic progression-free survival time (rPFS) [ Time Frame: Up to 36 months (~12 months of treatment and 24 months of follow-up) ]
    The investigator will estimate the rPFS by PCWG3-modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors).

  2. Percentage of patients with a reduction in PSA of at least 30% from baseline [ Time Frame: Up to ~12 months ]
    Using PCWG3 criteria

  3. Time to PSA progression [ Time Frame: Up to 36 months (~12 months of treatment and 24 months of follow-up) ]
    Using PCWG3 criteria

  4. PSA progression-free survival (PFS) [ Time Frame: Up to 36 months (~12 months of treatment and 24 months of follow-up) ]
  5. Duration of therapy (DOT) [ Time Frame: Up to ~12 months ]
  6. Duration of PSA Response (DOR) [ Time Frame: Up to 36 months (~12 months of treatment and 24 months of follow-up) ]
    From the time measurement criteria are met for PSA response until the first date that recurrent or progressive disease is objectively documented.

  7. Progression-free survival [ Time Frame: Up to 36 months (~12 months of treatment and 24 months of follow-up) ]
    From start of treatment to time of progression, whether PSA progression by PCWG3 criteria and/or RECIST 1.1 criteria as applicable.

  8. Overall survival [ Time Frame: Up to 36 months (~12 months of treatment and 24 months of follow-up) ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and voluntarily agree to participate by providing written informed consent for the trial.
  • Histologically confirmed prostate adenocarcinoma cancer, either pure or mixed. Small cell/neuroendocrine differentiation is not allowed.
  • Castrate levels of serum testosterone (≤ 50 ng/dL). Patients must continue androgen deprivation therapy with an LHRH analogue or antagonist if they have not undergone bilateral orchiectomy.
  • Patients must have metastatic disease; either non-measurable disease OR measurable disease per RECIST 1.1.
  • Progressive disease despite ongoing treatment with Androgen Deprivation Therapy (ADT).
  • Patients treated with first generation anti-androgen as most recent systemic therapy (e.g. bicalutamide, nilutamide) must have at least 4 weeks elapsed from treatment discontinuation to start of protocol therapy with evidence of disease progression (per protocol) following discontinuation of prior anti-androgen.
  • Minimum PSA at entry of 1 ng/mL is required.
  • ECOG Performance Status 0, 1 or 2.
  • Be ≥18 years of age on the day of signing informed consent.
  • Demonstrate adequate organ function.
  • Subjects must agree to use an adequate method of contraception as outlined in the protocol starting with the time of informed consent through 120 days after the last dose trial therapy.

Exclusion Criteria:

  • Prior chemotherapy and/or enzalutamide for metastatic castration-resistant prostate cancer. Chemotherapy administered in the castration-sensitive setting is allowed provided last dose of chemotherapy was greater than 6 months prior to study entry.
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to enrollment.
  • Has not recovered (i.e., AE ≤Grade 1 or at baseline) from AEs due to a previously administered agent. Subjects with ≤Grade 2 neuropathy or ≤Grade 2 alopecia are an exception to this criterion and are allowed if relevant toxicity is stabilized.
  • If subjects received major surgery they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting trial therapy.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. At the time of signing informed consent is a known regular user (including "recreational use") of any illicit drug(s) or had a recent history (within the last year) of drug or alcohol abuse.
  • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
  • Has known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Has received a live virus vaccine within 30 days of planned start of trial therapy.
  • Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable brain metastases (stability is normally defined as a period of 1 to 3 months in which there is no evidence of new or enlarging CNS metastases).
  • Has symptomatic ascites or pleural effusion; a subject who is clinically stable following treatment for these conditions is eligible.
  • Has had a prior allogeneic stem cell or bone marrow transplant.
  • Has known contraindication to aspirin (81 mg).

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): NCT03300505


Contacts
Layout table for location contacts
Contact: Ajjai Alva, MD 734-936-0091 ajjai@umich.edu

Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Ajjai Alva, MD University of Michigan

Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03300505     History of Changes
Other Study ID Numbers: UMCC 2017.055
HUM00130051 ( Other Identifier: University of Michigan )
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases