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Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT01940276
Collaborator
(none)
100
Enrollment
14
Locations
1
Arm
72.2
Actual Duration (Months)
7.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a non-comparative pilot open-label, parallel arm, multicenter study of abiraterone acetate in African American and Caucasian men with mCRPC. Patients will self-report on race and 50 patients will be enrolled into each group. Patients will be treated on open-label treatment until evidence of disease progression as defined by Prostate Cancer Working Group Two (PCWG2) definition or until two years at which point they will roll over to the standard of care at that time. The study agent abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles throughout the treatment period.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Open-label, Parallel Group Study of Abiraterone Acetate Plus Prednisone in African American and Caucasian Men With Metastatic Castrate-resistant Prostate Cancer
Actual Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Oct 8, 2019
Actual Study Completion Date :
Oct 8, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abiraterone Acetate and Prednisone

abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles

Drug: Abiraterone acetate
Other Names:
  • Zytiga

    • Drug: Prednisone

    Outcome Measures

    Primary Outcome Measures

    1. Median Radiographic Progression Free Survival (PFS) [up to 2 years]

      Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve.

    Secondary Outcome Measures

    1. Change in PSA Response [Baseline and up to 2 years]

      Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90%

    2. Median Time to PSA Progression [up to 2 years]

      Time to PSA progression as defined by PCWG 2 criteria is the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.

    3. Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml [up to 2 years]

      Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml

    4. Percent of Subjects Experiencing Hypertension [up to 2 years]

      Incidence and grade of hypertension in the two populations. (Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated)

    5. Overall Survival [up to 3 years]

      Length of patient's life after starting study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male, age ≥ 18 years

    • Karnofsky performance status ≥ 70

    • Life expectancy of ≥ 12 months

    • Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken, and should be able to swallow tablets whole, without crushing/chewing tablets

    • Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate

    • Adequate laboratory parameters

    • Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are excluded

    • Radiographic evidence of metastatic disease; evaluable non-target lesions and/or bone only metastasis are permitted

    • Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed. Screening serum testosterone must be <50 ng/dl

    • PSA ≥ 2.0 ng/mL

    • Evidence of of castration resistant disease on ADT as evidenced by one of the following:

    • Absolute rise in PSA of 2.0 ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level, OR

    • 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR

    • CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to modified PCWG2 criteria or modified RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies)

    • A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)

    • A minimum of 4 weeks elapsed off of sipuleucel-T prior to start of study drug

    • A minimum of 4 weeks from any major surgery prior to start of study drug

    • Self-reported race of either African American or Caucasian

    • Ability to swallow, retain, and absorb oral medication

    Exclusion Criteria:

    • Prior treatment with abiraterone acetate or enzalutamide

    • Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated

    • Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid

    • Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients

    • Pathological finding consistent with small cell carcinoma of the prostate

    • Symptomatic Liver or visceral organ metastasis

    • Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents

    • Known brain metastasis

    • Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC

    • Previously treated with ketoconazole for prostate cancer for greater than 7 days

    • Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1

    • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.

    • Poorly controlled diabetes

    • Active or symptomatic viral hepatitis or chronic liver disease

    • History of pituitary or adrenal dysfunction

    • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline

    • Atrial Fibrillation or other cardiac arrhythmia requiring therapy

    • Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months

    • Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1

    • Any condition which, in the opinion of the investigator, would preclude participation in this trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham VA Medical Center Birmingham Alabama United States 35233
    2 Tulane Cancer Center New Orleans Louisiana United States 70112
    3 Karmanos Cancer Institute Detroit Michigan United States 48201
    4 University of North Carolina Chapel Hill North Carolina United States 27599
    5 Duke University Medical Center Durham North Carolina United States 27710
    6 Maria Parham Medical Center Henderson North Carolina United States 27536
    7 Scotland Memorial Hospital Laurinburg North Carolina United States 28352
    8 Southeastern Regional Lumberton North Carolina United States 28359
    9 Duke Raleigh Hospital Raleigh North Carolina United States 27609
    10 W. G. 'Bill' Hefner VA Medical Center Salisbury North Carolina United States 28144
    11 Johnston Memorial Hospital Smithfield North Carolina United States 27577
    12 Wake Forest University Winston-Salem North Carolina United States 27157
    13 Spartanburg Regional Spartanburg South Carolina United States 29303
    14 Virginia Oncology Associates Hampton Virginia United States 23666

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Daniel George, MD, Duke University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT01940276
    Other Study ID Numbers:
    • Pro00046383
    • 212082PCR2018
    First Posted:
    Sep 12, 2013
    Last Update Posted:
    Dec 9, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Duke University
    Prostate cancer
    metastatic
    castrate resistant
    abiraterone acetate
    prednisone
    metastatic prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Prednisone
    Abiraterone Acetate

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Arm/Group Description Patients self identifying as white men who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation. Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
    Period Title: Overall Study
    STARTED 50 50
    COMPLETED 50 50
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title White Black Total
    Arm/Group Description Patients self identifying as white who received the study regimen Patients self identifying as black who received the study regimen Total of all reporting groups
    Overall Participants 50 50 100
    Age (years) [Median (Standard Deviation) ]
    Median (Standard Deviation) [years]
    68.2
    (7.8)
    69.05
    (9.2)
    68.5
    (8.5)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    50
    100%
    50
    100%
    100
    100%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    50
    100%
    50
    50%
    White
    50
    100%
    0
    0%
    50
    50%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Median Radiographic Progression Free Survival (PFS)
    Description Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve.
    Time Frame up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Arm/Group Description Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation. Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
    Measure Participants 50 50
    Median (95% Confidence Interval) [months]
    16.8
    16.6
    2. Secondary Outcome
    Title Change in PSA Response
    Description Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90%
    Time Frame Baseline and up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Arm/Group Description Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation. Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
    Measure Participants 50 50
    Percent of men with PSA declines > 30%
    78
    156%
    82
    164%
    Percent of men with PSA declines > 50%
    66
    132%
    74
    148%
    Percent of men with PSA declines > 90%
    38
    76%
    48
    96%
    3. Secondary Outcome
    Title Median Time to PSA Progression
    Description Time to PSA progression as defined by PCWG 2 criteria is the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.
    Time Frame up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Arm/Group Description Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation. Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
    Measure Participants 50 50
    Median (95% Confidence Interval) [months]
    11.5
    16.6
    4. Secondary Outcome
    Title Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
    Description Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml
    Time Frame up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Arm/Group Description Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation. Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
    Measure Participants 50 50
    PSA decline to < 0.1
    4
    8%
    9
    18%
    PSA decline to < 0.2
    5
    10%
    13
    26%
    5. Secondary Outcome
    Title Percent of Subjects Experiencing Hypertension
    Description Incidence and grade of hypertension in the two populations. (Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated)
    Time Frame up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Arm/Group Description Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation. Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
    Measure Participants 50 50
    All grades
    20
    40%
    23
    46%
    Grades 3 and 4
    8
    16%
    12
    24%
    6. Secondary Outcome
    Title Overall Survival
    Description Length of patient's life after starting study
    Time Frame up to 3 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Arm/Group Description Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation. Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
    Measure Participants 50 50
    Median (95% Confidence Interval) [months]
    35.7
    35.9

    Adverse Events

    Time Frame Up to 30 days post last dose
    Adverse Event Reporting Description
    Arm/Group Title Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Arm/Group Description Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation. Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
    All Cause Mortality
    Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/50 (0%) 0/50 (0%)
    Serious Adverse Events
    Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/50 (28%) 14/50 (28%)
    Cardiac disorders
    Supraventricular tachycardia 0/50 (0%) 1/50 (2%)
    Acute Congestive Heart Failure 0/50 (0%) 1/50 (2%)
    Gastrointestinal disorders
    Rectal hemorrhage 1/50 (2%) 0/50 (0%)
    Colonic perforation 1/50 (2%) 0/50 (0%)
    Ileus 1/50 (2%) 0/50 (0%)
    Gastroenteritis 0/50 (0%) 1/50 (2%)
    Nausea 0/50 (0%) 1/50 (2%)
    General disorders
    Fever 1/50 (2%) 1/50 (2%)
    Pain 2/50 (4%) 0/50 (0%)
    Flu like symptoms 1/50 (2%) 0/50 (0%)
    Accidental Overdose 0/50 (0%) 1/50 (2%)
    Infections and infestations
    Urinary tract infection 2/50 (4%) 2/50 (4%)
    Sepsis 0/50 (0%) 1/50 (2%)
    Metabolism and nutrition disorders
    Hypokalemia 1/50 (2%) 0/50 (0%)
    Dehydration 1/50 (2%) 1/50 (2%)
    Hyperglycemia 0/50 (0%) 2/50 (4%)
    Musculoskeletal and connective tissue disorders
    Generalized muscle weakness 1/50 (2%) 0/50 (0%)
    Pain in extremity 1/50 (2%) 0/50 (0%)
    Bone pain 1/50 (2%) 0/50 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 1/50 (2%) 0/50 (0%)
    Nervous system disorders
    Paresthesia 1/50 (2%) 0/50 (0%)
    Seizure 0/50 (0%) 1/50 (2%)
    Transient ischemic attacks 0/50 (0%) 1/50 (2%)
    Cord Compression 0/50 (0%) 1/50 (2%)
    Psychiatric disorders
    Confusion 1/50 (2%) 0/50 (0%)
    Altered Mental State 1/50 (2%) 0/50 (0%)
    Renal and urinary disorders
    Urinary retention 1/50 (2%) 3/50 (6%)
    Urinary tract obstruction 0/50 (0%) 2/50 (4%)
    Hematuria 0/50 (0%) 2/50 (4%)
    Acute kidney injury 0/50 (0%) 1/50 (2%)
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis 1/50 (2%) 0/50 (0%)
    Asthmatic episode 0/50 (0%) 1/50 (2%)
    COPD exacerbation 0/50 (0%) 1/50 (2%)
    Hypercapnic Respiratory Failure 0/50 (0%) 1/50 (2%)
    Pneumonia 0/50 (0%) 1/50 (2%)
    Bilaterial pneumonia 0/50 (0%) 1/50 (2%)
    Skin and subcutaneous tissue disorders
    Squamous cell carcinoma of the face 1/50 (2%) 0/50 (0%)
    Surgical and medical procedures
    Surgical resection of neck cancer 1/50 (2%) 0/50 (0%)
    Vascular disorders
    Thromboembolic event 2/50 (4%) 0/50 (0%)
    Other (Not Including Serious) Adverse Events
    Abiraterone Acetate and Prednisone: White Men Abiraterone Acetate and Prednisone: African American Men
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 50/50 (100%) 50/50 (100%)
    Blood and lymphatic system disorders
    Anemia 7/50 (14%) 8/50 (16%)
    Leukocytosis 0/50 (0%) 1/50 (2%)
    Increased bleeding tendency related to Eliquis 1/50 (2%) 0/50 (0%)
    Cardiac disorders
    Atrial fibrillation 1/50 (2%) 0/50 (0%)
    Atrial flutter 0/50 (0%) 1/50 (2%)
    Acute Congestive Heart Failure 0/50 (0%) 1/50 (2%)
    Bradycardia 0/50 (0%) 1/50 (2%)
    Irregular heart beat 0/50 (0%) 1/50 (2%)
    Conduction disorder 0/50 (0%) 1/50 (2%)
    Sinus bradycardia 1/50 (2%) 0/50 (0%)
    Sinus tachycardia 1/50 (2%) 0/50 (0%)
    Supraventricular tachycardia 0/50 (0%) 1/50 (2%)
    Ear and labyrinth disorders
    Tinnitus 0/50 (0%) 1/50 (2%)
    Vertigo 0/50 (0%) 1/50 (2%)
    Endocrine disorders
    Adrenal insufficiency 1/50 (2%) 0/50 (0%)
    Eye disorders
    Blurred vision 1/50 (2%) 1/50 (2%)
    Dry eye 1/50 (2%) 0/50 (0%)
    Conjunctival hemorrhage in right eye 1/50 (2%) 0/50 (0%)
    Redness of right eye 0/50 (0%) 1/50 (2%)
    Bilateral arcus senilis 0/50 (0%) 1/50 (2%)
    Eye pain 0/50 (0%) 1/50 (2%)
    Watering eyes 0/50 (0%) 1/50 (2%)
    Gastrointestinal disorders
    Abdominal distension 0/50 (0%) 1/50 (2%)
    Abdominal pain 4/50 (8%) 0/50 (0%)
    Anal hemorrhage 0/50 (0%) 1/50 (2%)
    Colonic perforation 1/50 (2%) 0/50 (0%)
    Constipation 5/50 (10%) 14/50 (28%)
    Dental caries 0/50 (0%) 1/50 (2%)
    Diarrhea 6/50 (12%) 3/50 (6%)
    Dry mouth 3/50 (6%) 0/50 (0%)
    Dyspepsia 3/50 (6%) 7/50 (14%)
    Flatulence 0/50 (0%) 1/50 (2%)
    Gastritis 0/50 (0%) 1/50 (2%)
    Gastroesophageal reflux disease 1/50 (2%) 2/50 (4%)
    Blood in stool 0/50 (0%) 1/50 (2%)
    Gastroenteritis 0/50 (0%) 1/50 (2%)
    Heartburn 1/50 (2%) 0/50 (0%)
    Hernia 1/50 (2%) 0/50 (0%)
    Sick 0/50 (0%) 1/50 (2%)
    Upset stomach 0/50 (0%) 1/50 (2%)
    Gastrointestinal pain 0/50 (0%) 1/50 (2%)
    Hemorrhoids 0/50 (0%) 2/50 (4%)
    Ileus 1/50 (2%) 0/50 (0%)
    Nausea 8/50 (16%) 8/50 (16%)
    Oral pain 0/50 (0%) 2/50 (4%)
    Rectal hemorrhage 1/50 (2%) 0/50 (0%)
    Stomach pain 1/50 (2%) 0/50 (0%)
    Vomiting 8/50 (16%) 3/50 (6%)
    General disorders
    Chills 0/50 (0%) 1/50 (2%)
    Edema face 0/50 (0%) 2/50 (4%)
    Edema limbs 8/50 (16%) 13/50 (26%)
    Fatigue 21/50 (42%) 13/50 (26%)
    Fever 3/50 (6%) 2/50 (4%)
    Flu like symptoms 5/50 (10%) 4/50 (8%)
    Gait disturbance 1/50 (2%) 0/50 (0%)
    Accidental overdose 0/50 (0%) 1/50 (2%)
    Edema face and neck 0/50 (0%) 1/50 (2%)
    Cold-like symptoms 1/50 (2%) 0/50 (0%)
    Overdose 0/50 (0%) 1/50 (2%)
    Irritability 1/50 (2%) 0/50 (0%)
    Localized edema 0/50 (0%) 1/50 (2%)
    Malaise 1/50 (2%) 0/50 (0%)
    Non-cardiac chest pain 0/50 (0%) 2/50 (4%)
    Pain 12/50 (24%) 12/50 (24%)
    Hepatobiliary disorders
    Gallbladder pain 1/50 (2%) 0/50 (0%)
    Immune system disorders
    Allergic reaction 2/50 (4%) 0/50 (0%)
    Infections and infestations
    Bronchial infection 3/50 (6%) 0/50 (0%)
    Black hairy tongue 1/50 (2%) 0/50 (0%)
    Conjunctivitis 0/50 (0%) 1/50 (2%)
    Thrush, related to chemo 1/50 (2%) 0/50 (0%)
    Viral infection 1/50 (2%) 0/50 (0%)
    Mouth sores 0/50 (0%) 1/50 (2%)
    Lung infection 0/50 (0%) 2/50 (4%)
    Mucosal infection 0/50 (0%) 1/50 (2%)
    Papulopustular rash 0/50 (0%) 2/50 (4%)
    Sepsis 0/50 (0%) 1/50 (2%)
    Skin infection 0/50 (0%) 1/50 (2%)
    Tooth infection 0/50 (0%) 1/50 (2%)
    Upper respiratory infection 2/50 (4%) 4/50 (8%)
    Urinary tract infection 5/50 (10%) 6/50 (12%)
    Injury, poisoning and procedural complications
    Bruising 3/50 (6%) 1/50 (2%)
    Fall 7/50 (14%) 4/50 (8%)
    Fracture 2/50 (4%) 1/50 (2%)
    Wound complication 1/50 (2%) 0/50 (0%)
    Investigations
    Lymphocyte count decreased 0/50 (0%) 1/50 (2%)
    Neutrophil count decreased 0/50 (0%) 1/50 (2%)
    Platelet count decreased 2/50 (4%) 2/50 (4%)
    White blood cell decreased 1/50 (2%) 1/50 (2%)
    Alanine aminotransferase increased 5/50 (10%) 5/50 (10%)
    Alkaline phosphatase increased 2/50 (4%) 5/50 (10%)
    Aspartate aminotransferase increased 5/50 (10%) 5/50 (10%)
    Blood bilirubin increased 0/50 (0%) 2/50 (4%)
    Creatinine increased 1/50 (2%) 2/50 (4%)
    Elevated ANC 0/50 (0%) 1/50 (2%)
    Folic acid deficiency 1/50 (2%) 0/50 (0%)
    Urine output decreased 0/50 (0%) 1/50 (2%)
    Weight gain 5/50 (10%) 2/50 (4%)
    Weight loss 3/50 (6%) 1/50 (2%)
    Metabolism and nutrition disorders
    Anorexia 2/50 (4%) 10/50 (20%)
    Dehydration 2/50 (4%) 1/50 (2%)
    Glucose intolerance 0/50 (0%) 1/50 (2%)
    Hypercalcemia 1/50 (2%) 2/50 (4%)
    Hyperglycemia 7/50 (14%) 13/50 (26%)
    Hyperkalemia 3/50 (6%) 1/50 (2%)
    Hypermagnesemia 1/50 (2%) 1/50 (2%)
    Hypernatremia 0/50 (0%) 1/50 (2%)
    Hypoalbuminemia 1/50 (2%) 3/50 (6%)
    Hypocalcemia 3/50 (6%) 2/50 (4%)
    Hypokalemia 10/50 (20%) 17/50 (34%)
    Hypomagnesemia 4/50 (8%) 8/50 (16%)
    Hyponatremia 2/50 (4%) 3/50 (6%)
    Hypophosphatemia 2/50 (4%) 3/50 (6%)
    Increased appetite 1/50 (2%) 0/50 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/50 (2%) 3/50 (6%)
    Arthritis 0/50 (0%) 1/50 (2%)
    Back pain 3/50 (6%) 5/50 (10%)
    Bone pain 2/50 (4%) 1/50 (2%)
    Buttock pain 1/50 (2%) 0/50 (0%)
    Flank pain 0/50 (0%) 1/50 (2%)
    Generalized muscle weakness 3/50 (6%) 2/50 (4%)
    Muscle weakness left-sided 1/50 (2%) 0/50 (0%)
    Muscle weakness lower limb 0/50 (0%) 3/50 (6%)
    Muscle weakness right-sided 0/50 (0%) 1/50 (2%)
    Back stiffness 0/50 (0%) 1/50 (2%)
    Bilateral leg cramps 1/50 (2%) 0/50 (0%)
    Muscle spasm in right hand 0/50 (0%) 1/50 (2%)
    Neck stiffness 0/50 (0%) 1/50 (2%)
    Bilateral leg weakness 1/50 (2%) 0/50 (0%)
    Bilateral lower leg cramps 2/50 (4%) 0/50 (0%)
    Burning sensation in bilateral lower extremeties 1/50 (2%) 0/50 (0%)
    Muscle spasm 0/50 (0%) 1/50 (2%)
    Right leg aching 0/50 (0%) 1/50 (2%)
    Weakness, mild and intermittent left upper knee 0/50 (0%) 1/50 (2%)
    Myalgia 0/50 (0%) 3/50 (6%)
    Neck pain 0/50 (0%) 1/50 (2%)
    Pain in extremity 9/50 (18%) 7/50 (14%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 1/50 (2%) 0/50 (0%)
    Squamous cell carcinoma, neck 1/50 (2%) 0/50 (0%)
    Smoldering myeloma 1/50 (2%) 0/50 (0%)
    Bladder cancer 1/50 (2%) 0/50 (0%)
    Nervous system disorders
    Dizziness 4/50 (8%) 5/50 (10%)
    Dysgeusia 2/50 (4%) 0/50 (0%)
    Headache 9/50 (18%) 3/50 (6%)
    Memory impairment 2/50 (4%) 1/50 (2%)
    Movements involuntary 1/50 (2%) 0/50 (0%)
    Cord Compression 0/50 (0%) 1/50 (2%)
    Tingling in bilateral legs at HS "like restless legs" 0/50 (0%) 1/50 (2%)
    Paresthesia 5/50 (10%) 2/50 (4%)
    Peripheral sensory neuropathy 3/50 (6%) 3/50 (6%)
    Seizure 0/50 (0%) 1/50 (2%)
    Sinus pain 0/50 (0%) 1/50 (2%)
    Somnolence 1/50 (2%) 0/50 (0%)
    Syncope 0/50 (0%) 1/50 (2%)
    Transient ischemic attacks 0/50 (0%) 1/50 (2%)
    Psychiatric disorders
    Agitation 0/50 (0%) 1/50 (2%)
    Anxiety 1/50 (2%) 0/50 (0%)
    Confusion 2/50 (4%) 0/50 (0%)
    Depression 1/50 (2%) 0/50 (0%)
    Insomnia 2/50 (4%) 6/50 (12%)
    Altered mental state 1/50 (2%) 0/50 (0%)
    Altered mental status 0/50 (0%) 1/50 (2%)
    Renal and urinary disorders
    Acute kidney injury 0/50 (0%) 2/50 (4%)
    Bladder spasm 1/50 (2%) 2/50 (4%)
    Cystitis noninfective 2/50 (4%) 0/50 (0%)
    Hematuria 3/50 (6%) 5/50 (10%)
    Left hydronephrosis 1/50 (2%) 0/50 (0%)
    Nocturia 1/50 (2%) 1/50 (2%)
    Burning during urination 1/50 (2%) 0/50 (0%)
    Burning upon urinating 0/50 (0%) 1/50 (2%)
    Increased BUN 1/50 (2%) 0/50 (0%)
    Pain during urination 0/50 (0%) 1/50 (2%)
    Renal calculi 2/50 (4%) 0/50 (0%)
    Renal colic 1/50 (2%) 0/50 (0%)
    Urinary frequency 5/50 (10%) 5/50 (10%)
    Urinary incontinence 3/50 (6%) 3/50 (6%)
    Urinary retention 4/50 (8%) 4/50 (8%)
    Urinary tract obstruction 1/50 (2%) 2/50 (4%)
    Urinary tract pain 1/50 (2%) 2/50 (4%)
    Urinary urgency 2/50 (4%) 1/50 (2%)
    Reproductive system and breast disorders
    Breast pain 1/50 (2%) 0/50 (0%)
    Penile erosion 0/50 (0%) 1/50 (2%)
    Respiratory, thoracic and mediastinal disorders
    Allergic rhinitis 2/50 (4%) 1/50 (2%)
    Bronchopulmonary hemorrhage 0/50 (0%) 1/50 (2%)
    Cough 15/50 (30%) 9/50 (18%)
    Dyspnea 7/50 (14%) 9/50 (18%)
    Hypoxia 0/50 (0%) 1/50 (2%)
    Nasal congestion 2/50 (4%) 2/50 (4%)
    Pharyngeal mucositis 1/50 (2%) 0/50 (0%)
    Pleural effusion 1/50 (2%) 0/50 (0%)
    Pneumonitis 1/50 (2%) 0/50 (0%)
    Productive cough 0/50 (0%) 1/50 (2%)
    Asthmatic episode 0/50 (0%) 1/50 (2%)
    Bilaterial pneumonia 0/50 (0%) 1/50 (2%)
    COPD exacerbation 0/50 (0%) 1/50 (2%)
    Hypercapnic Respiratory Failure 0/50 (0%) 1/50 (2%)
    Pneumonia 0/50 (0%) 1/50 (2%)
    Sore throat 0/50 (0%) 2/50 (4%)
    Wheezing 1/50 (2%) 0/50 (0%)
    Skin and subcutaneous tissue disorders
    Alopecia 1/50 (2%) 0/50 (0%)
    Dry skin 1/50 (2%) 1/50 (2%)
    Periorbital edema 0/50 (0%) 1/50 (2%)
    Pruritus 1/50 (2%) 1/50 (2%)
    Rash acneiform 1/50 (2%) 2/50 (4%)
    Rash maculo-papular 5/50 (10%) 1/50 (2%)
    Other 2/50 (4%) 0/50 (0%)
    "Poison ivy" per patient, dermatitis on left forearm 0/50 (0%) 1/50 (2%)
    Skin ulceration gluteal fold bilaterally 0/50 (0%) 1/50 (2%)
    Blotchy red spot forearm 1/50 (2%) 0/50 (0%)
    Boils-Four on right leg only 0/50 (0%) 1/50 (2%)
    Erythema & swelling of abd incision 1/50 (2%) 0/50 (0%)
    Rash in groin 0/50 (0%) 1/50 (2%)
    Redness in hands and feet 1/50 (2%) 0/50 (0%)
    Basal skin cancer (removed from the nose) 1/50 (2%) 0/50 (0%)
    Open wound to left hip 0/50 (0%) 1/50 (2%)
    Sebaceous cyst 1/50 (2%) 0/50 (0%)
    Squamous cell carcinoma of the face 1/50 (2%) 0/50 (0%)
    Skin hyperpigmentation 0/50 (0%) 1/50 (2%)
    Skin hypopigmentation 1/50 (2%) 0/50 (0%)
    Surgical and medical procedures
    Bilateral Blepharoplasty 1/50 (2%) 0/50 (0%)
    Colostomy Reversal 1/50 (2%) 0/50 (0%)
    Tooth extractions 0/50 (0%) 1/50 (2%)
    Surgical resection of neck cancer 1/50 (2%) 0/50 (0%)
    Vascular disorders
    Flushing 1/50 (2%) 0/50 (0%)
    Hematoma 0/50 (0%) 1/50 (2%)
    Hot flashes 1/50 (2%) 10/50 (20%)
    Hypertension 20/50 (40%) 23/50 (46%)
    Hypotension 1/50 (2%) 0/50 (0%)
    Peripheral ischemia 1/50 (2%) 0/50 (0%)
    Thromboembolic event 6/50 (12%) 1/50 (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/Title Daniel George, MD
    Organization Duke University
    Phone 919-668-4615
    Email daniel.george@duke.edu
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT01940276
    Other Study ID Numbers:
    • Pro00046383
    • 212082PCR2018
    First Posted:
    Sep 12, 2013
    Last Update Posted:
    Dec 9, 2020
    Last Verified:
    Nov 1, 2020