Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance

Sponsor
University of Washington (Other)
Overall Status
Terminated
CT.gov ID
NCT02721979
Collaborator
Janssen Scientific Affairs, LLC (Industry), National Cancer Institute (NCI) (NIH)
24
Enrollment
1
Location
1
Arm
48.9
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial studies how well apalutamide works in treating patients with prostate cancer who are in active surveillance. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Apalutamide
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
Phase 2

Detailed Description

OUTLINE:

Patients receive apalutamide orally (PO) once daily (QD) for 90 days in the absence of disease progression or unacceptable toxicity.

After completion of the study treatment, patients are followed up at 180, 365, 545, and 730 days; and at years 3, 4 and 5 by medical record review.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Apalutamide in Active Surveillance Patients
Actual Study Start Date :
Nov 2, 2017
Actual Primary Completion Date :
Feb 12, 2020
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treatment (apalutamide)

Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.

Drug: Apalutamide
Given PO
Other Names:
  • ARN 509
  • ARN-509
  • ARN509
  • JNJ 56021927
  • JNJ-56021927
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Negative (i.e. no Residual Carcinoma) Site Directed and Systematic Prostate Biopsy Rate [At 90 days]

      Negative rate will be presented as the percent of subjects with a negative repeat biopsy, and will be calculated as: (number of patients with a negative biopsy following 90-days of apalutamide) / (total number of patients enrolled on the study) x 100. A 1-sample chi-square test will be used to compare the proportion with a negative repeat biopsy to the null hypothesis value of 20% (above). The 95% confidence interval will be computed.

    Secondary Outcome Measures

    1. Percentage of Patients Exiting Active Surveillance Due to Pathologic Reclassification [At 2 years]

      The percentage of patients that exit active surveillance due to pathologic reclassification (e.g. increasing tumor volume or gleason score) will be computed along with its 95% confidence interval.

    2. Percentage of Patients Exiting Active Surveillance for Any Reason [At 2 years]

      Percentage of patients exiting active surveillance for any reason will be computed along with its 95% confidence interval.

    3. Percent of Men Undergoing of Local Treatment [At 2 years]

      Computed along with its 95% confidence interval.

    4. Local Treatment Free Survival [Up to 730 days]

      Kaplan-Meier methods and 95% confidence interval will be estimated using Greenwood's formula.

    5. Prostate-specific Antigen Progression Rate [At 2 years]

      Prostate-specific antigen progression rate will be defined per Prostate Cancer Working Group 2 criteria (i.e. confirmed rising prostate-specific antigen >= 2 ng/mL at least one week apart) and will be computed along with 95% confidence interval.

    6. Prostate-specific Antigen Progression Free Survival as Defined by the Prostate Cancer Working Group 2 Criteria [At 2 years]

      Prostate-specific antigen progression free survival will be estimated using Kaplan-Meier methods and 95% confidence interval will be estimated using Greenwood's formula.

    7. Change in Radiographic Disappearance of Magnetic Resonance Imaging Detectable Prostate Cancer [Baseline to up to 90 days]

      This calculates the percentage of participants with radiographic disappearance of magnetic resonance imaging detectable prostate cancer. This is only in patients with a baseline nodule that is Prostate Imaging Reporting and Data System 3 or more and > 5 mm.

    8. Incidence of Adverse Events [Up to 730 days]

      As assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.

    9. Severity of Adverse Events [Up to 730 days]

      As assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.

    10. Change in Quality of Life: FACT-P Assessment [Baseline to up to 730 days]

      As assessed using the Functional Assessment of Cancer Therapy-Prostate surveys. Functional Assessment of Cancer Therapy-Prostate is a validated quality of life survey specific for patients with prostate cancer.

    11. Change in Quality of Life: SF-36 Assessment [Baseline to up to 730 days]

      As assessed using the Short Form-36 survey. Short Form-36 is a validated quality of life survey. This is a generic survey to assess an individual's overall well-being, and is not specific to one disease.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Have signed an informed consent document

    • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol

    • Written authorization for use and release of health and research study information has been obtained

    • Life expectancy >= 10 years (as determined by the treating physician)

    • Eastern Cooperative Oncology Group (ECOG) performance status =< 1

    • Histologically confirmed adenocarcinoma of the prostate as documented by a minimum 12 core prostate biopsy completed within 1-year of enrollment (note: most recent prostate biopsy must have demonstrated prostatic adenocarcinoma)

    • Favorable risk prostate cancer as defined by:

    • Very low-risk:

    • Clinical stage T1c disease

    • PSA density (PSAD) < 0.15 ng/mL

    • Gleason score 6

    • =< 2 core biopsies with =< 50% involvement of any biopsy core with cancer, or unilateral disease =< 2 core biopsies with any percentage involvement OR

    • Low risk:

    • Clinical stage =< T2a

    • PSA < 15 ng/mL

    • Gleason score 6 OR

    • Low-intermediate risk:

    • Clinical stage T1c

    • PSA < 15 ng/ml

    • Gleason 3+4 present in =< 50% of one core/site as detected by systematic biopsy or MRI/transrectal ultrasound (TRUS) fusion guided biopsy

    • Gleason 6 disease in all other cores / sites

    • Willing and qualified for active surveillance at Johns Hopkins or the University of Washington

    • Serum testosterone >= 150 ng/dL

    • Able to swallow the study drugs whole as a tablet

    • Hemoglobin >= 9.0 g/dL, (at screening), independent of transfusion and/or growth factors within 3 months prior to registration

    • Platelet count >= 100,000 x 10^9/uL (at screening) independent of transfusion and/or growth factors within 3 months prior to registration

    • Serum albumin >= 3.0 g/dL (at screening)

    • Glomerular filtration rate (GFR) >= 45 mL/min (at screening)

    • Serum potassium >= 3.5 mmol/L (at screening)

    • Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (at screening) (note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 × ULN (at screening)

    • Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry

    • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

    Exclusion Criteria:
    • Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)

    • Prior use of ARN-509 (apalutamide)

    • Have known allergies, hypersensitivity, or intolerance to ARN-509 (apalutamide) or its excipients

    • Prior or ongoing systemic therapy for prostate cancer including, but not limited to:

    • Hormonal therapy (e.g. leuprolide, goserelin, triptorelin)

    • Cytochrome P450 (CYP)-17 inhibitors (e.g. abiraterone, ketoconazole)

    • Antiandrogens (e.g. bicalutamide, nilutamide)

    • Second generation antiandrogens (e.g. enzalutamide)

    • Immunotherapy (e.g. sipuleucel-T, ipilimumab)

    • Chemotherapy (e.g. docetaxel, cabazitaxel)

    • Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements

    • History of any of the following:

    • Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to registration, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)

    • Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration

    • Any condition that in the opinion of the investigator, would preclude participation in this study

    • Current evidence of any of the following:

    • Uncontrolled hypertension

    • Gastrointestinal disorder affecting absorption

    • Active infection (e.g. human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated

    • Any condition that in the opinion of the investigator, would preclude participation in this study

    • The use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)

    • The use of strong CYP3A4 inhibitors, including: itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice (or grapefruits)

    • Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide

    • Strong CYP3A4 inducers, including: phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, efavirenz, tipranavir, St. John's wort

    **Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide

    • Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Fred Hutch/University of Washington Cancer ConsortiumSeattleWashingtonUnited States98109

    Sponsors and Collaborators

    • University of Washington
    • Janssen Scientific Affairs, LLC
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Michael Schweizer, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Schweizer, Assistant Professor, Division of Medical Oncology, University of Washington
    ClinicalTrials.gov Identifier:
    NCT02721979
    Other Study ID Numbers:
    • 9582
    • NCI-2016-00221
    • 9582
    • P30CA015704
    • RG1716037
    First Posted:
    Mar 29, 2016
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsThe screening study procedures are conducted within 30 days prior to enrollment. The only exception to this would be the surveillance prostate biopsy.
    Pre-assignment Detail24 subjects signed consent for this study, but only 23 were eligible to enter into the treatment phase.
    Arm/Group TitleApalutamide
    Arm/Group DescriptionDay 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity. Apalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    Period Title: Overall Study
    STARTED23
    COMPLETED22
    NOT COMPLETED1

    Baseline Characteristics

    Arm/Group TitleTreatment (Apalutamide)
    Arm/Group DescriptionPatients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity. Apalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    Overall Participants24
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    10
    41.7%
    >=65 years
    14
    58.3%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    Male
    24
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    24
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    1
    4.2%
    White
    23
    95.8%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    24
    100%
    Patients with very low risk disease at baseline (Count of Participants)
    Count of Participants [Participants]
    9
    37.5%

    Outcome Measures

    1. Primary Outcome
    TitleNegative (i.e. no Residual Carcinoma) Site Directed and Systematic Prostate Biopsy Rate
    DescriptionNegative rate will be presented as the percent of subjects with a negative repeat biopsy, and will be calculated as: (number of patients with a negative biopsy following 90-days of apalutamide) / (total number of patients enrolled on the study) x 100. A 1-sample chi-square test will be used to compare the proportion with a negative repeat biopsy to the null hypothesis value of 20% (above). The 95% confidence interval will be computed.
    Time FrameAt 90 days

    Outcome Measure Data

    Analysis Population Description
    These are patients that had 90 days of treatment and had post-treatment biopsies.
    Arm/Group TitleApalutamide
    Arm/Group DescriptionDay 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity. Apalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    Measure Participants22
    Number (95% Confidence Interval) [percentage of subjects]
    59
    2. Secondary Outcome
    TitlePercentage of Patients Exiting Active Surveillance Due to Pathologic Reclassification
    DescriptionThe percentage of patients that exit active surveillance due to pathologic reclassification (e.g. increasing tumor volume or gleason score) will be computed along with its 95% confidence interval.
    Time FrameAt 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    3. Secondary Outcome
    TitlePercentage of Patients Exiting Active Surveillance for Any Reason
    DescriptionPercentage of patients exiting active surveillance for any reason will be computed along with its 95% confidence interval.
    Time FrameAt 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Secondary Outcome
    TitlePercent of Men Undergoing of Local Treatment
    DescriptionComputed along with its 95% confidence interval.
    Time FrameAt 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Secondary Outcome
    TitleLocal Treatment Free Survival
    DescriptionKaplan-Meier methods and 95% confidence interval will be estimated using Greenwood's formula.
    Time FrameUp to 730 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    6. Secondary Outcome
    TitleProstate-specific Antigen Progression Rate
    DescriptionProstate-specific antigen progression rate will be defined per Prostate Cancer Working Group 2 criteria (i.e. confirmed rising prostate-specific antigen >= 2 ng/mL at least one week apart) and will be computed along with 95% confidence interval.
    Time FrameAt 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    7. Secondary Outcome
    TitleProstate-specific Antigen Progression Free Survival as Defined by the Prostate Cancer Working Group 2 Criteria
    DescriptionProstate-specific antigen progression free survival will be estimated using Kaplan-Meier methods and 95% confidence interval will be estimated using Greenwood's formula.
    Time FrameAt 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    8. Secondary Outcome
    TitleChange in Radiographic Disappearance of Magnetic Resonance Imaging Detectable Prostate Cancer
    DescriptionThis calculates the percentage of participants with radiographic disappearance of magnetic resonance imaging detectable prostate cancer. This is only in patients with a baseline nodule that is Prostate Imaging Reporting and Data System 3 or more and > 5 mm.
    Time FrameBaseline to up to 90 days

    Outcome Measure Data

    Analysis Population Description
    Only 1 patient had paired MRI at baseline and again at post-treatment.
    Arm/Group TitleApalutamide
    Arm/Group DescriptionDay 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity. Apalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    Measure Participants1
    Number [percentage of participants]
    0
    0%
    9. Secondary Outcome
    TitleIncidence of Adverse Events
    DescriptionAs assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
    Time FrameUp to 730 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    10. Secondary Outcome
    TitleSeverity of Adverse Events
    DescriptionAs assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
    Time FrameUp to 730 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    11. Secondary Outcome
    TitleChange in Quality of Life: FACT-P Assessment
    DescriptionAs assessed using the Functional Assessment of Cancer Therapy-Prostate surveys. Functional Assessment of Cancer Therapy-Prostate is a validated quality of life survey specific for patients with prostate cancer.
    Time FrameBaseline to up to 730 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    12. Secondary Outcome
    TitleChange in Quality of Life: SF-36 Assessment
    DescriptionAs assessed using the Short Form-36 survey. Short Form-36 is a validated quality of life survey. This is a generic survey to assess an individual's overall well-being, and is not specific to one disease.
    Time FrameBaseline to up to 730 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time FrameFrom Day 1 until Day 90.
    Adverse Event Reporting Description
    Arm/Group TitleApalutamide
    Arm/Group DescriptionDay 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity. Apalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    All Cause Mortality
    Apalutamide
    Affected / at Risk (%)# Events
    Total0/23 (0%)
    Serious Adverse Events
    Apalutamide
    Affected / at Risk (%)# Events
    Total0/23 (0%)
    Other (Not Including Serious) Adverse Events
    Apalutamide
    Affected / at Risk (%)# Events
    Total23/23 (100%)
    Blood and lymphatic system disorders
    Anemia1/23 (4.3%) 1
    Hypocalcemia1/23 (4.3%) 1
    Hypertension1/23 (4.3%) 1
    Cardiac disorders
    Tachycardia1/23 (4.3%) 1
    Atrial Flutter1/23 (4.3%) 1
    Endocrine disorders
    Hypothyroidism1/23 (4.3%) 1
    Eye disorders
    Impaired Vision1/23 (4.3%) 1
    Gastrointestinal disorders
    Nausea2/23 (8.7%) 2
    Rectal Hemorrhage1/23 (4.3%) 1
    Constipation1/23 (4.3%) 1
    Increased Bowel Movement Frequency1/23 (4.3%) 1
    Muscositis Oral1/23 (4.3%) 1
    Stomach Pain1/23 (4.3%) 1
    Dyspepsia1/23 (4.3%) 1
    Clostridium Difficile Enteritis1/23 (4.3%) 1
    General disorders
    Fatigue/Decreased Energy18/23 (78.3%) 18
    Flu Like Symptoms1/23 (4.3%) 1
    Immune system disorders
    Sinusitis1/23 (4.3%) 1
    Sore Throat1/23 (4.3%) 1
    Infections and infestations
    Rhinorrhea1/23 (4.3%) 1
    Shingles1/23 (4.3%) 1
    Injury, poisoning and procedural complications
    Fall1/23 (4.3%) 1
    Investigations
    Increased/Elevated TSH4/23 (17.4%) 4
    Alanine Aminotransferase Increased1/23 (4.3%) 1
    Aspartate Aminotransferase Increased2/23 (8.7%) 2
    Metabolism and nutrition disorders
    Weight Loss/Anorexia5/23 (21.7%) 7
    Musculoskeletal and connective tissue disorders
    Arthralgia6/23 (26.1%) 6
    Edema1/23 (4.3%) 1
    Myalgia2/23 (8.7%) 2
    Cramp1/23 (4.3%) 1
    Akathisia1/23 (4.3%) 1
    Nervous system disorders
    Dysgeusia7/23 (30.4%) 7
    Tingling1/23 (4.3%) 1
    Postural Dizziness/Balance Changes4/23 (17.4%) 4
    Lightheadedness2/23 (8.7%) 2
    Headache1/23 (4.3%) 1
    Psychiatric disorders
    Insomnia2/23 (8.7%) 2
    Libido Decreased5/23 (21.7%) 5
    Labile Mood1/23 (4.3%) 1
    Cognitive Disturbance1/23 (4.3%) 1
    Memory Impairment/Forgetfulness/Amnesia3/23 (13%) 3
    Brain Fog1/23 (4.3%) 1
    Concentration Impairment1/23 (4.3%) 1
    Anxiety1/23 (4.3%) 1
    Decreased Mental Acuity1/23 (4.3%) 1
    Renal and urinary disorders
    Lower Urinary Tract Symptoms2/23 (8.7%) 2
    Dribbling1/23 (4.3%) 1
    Hematuria1/23 (4.3%) 1
    Reproductive system and breast disorders
    Gynecomastia6/23 (26.1%) 6
    Nipple Sensitivity/Tenderness11/23 (47.8%) 11
    Mastodynia2/23 (8.7%) 2
    Erectile Dysfunction1/23 (4.3%) 1
    Breast Tenderness1/23 (4.3%) 1
    Ejaculation Disorder1/23 (4.3%) 1
    Nipple Itchiness1/23 (4.3%) 1
    Perceived Shrinking of Genitals1/23 (4.3%) 1
    Testicle Pain1/23 (4.3%) 1
    Bronchitis1/23 (4.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough1/23 (4.3%) 1
    Upper Respiratory Infection Symptoms2/23 (8.7%) 2
    Chest Tightness1/23 (4.3%) 1
    Skin and subcutaneous tissue disorders
    Erythema1/23 (4.3%) 1
    Pruritis3/23 (13%) 3
    Rash7/23 (30.4%) 7
    Dry Skin3/23 (13%) 3
    Cellulitis1/23 (4.3%) 1
    Lack of Body Odor1/23 (4.3%) 1
    Burning Sensation1/23 (4.3%) 1
    Painful Callus Bumps1/23 (4.3%) 1
    Vascular disorders
    Hot Flashes5/23 (21.7%) 5
    Warmer Body2/23 (8.7%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Michael Schweizer
    OrganizationUniversity of Washington
    Phone(206) 606-6252
    Emailschweize@uw.edu
    Responsible Party:
    Michael Schweizer, Assistant Professor, Division of Medical Oncology, University of Washington
    ClinicalTrials.gov Identifier:
    NCT02721979
    Other Study ID Numbers:
    • 9582
    • NCI-2016-00221
    • 9582
    • P30CA015704
    • RG1716037
    First Posted:
    Mar 29, 2016
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Dec 1, 2021