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A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02059213
Recruitment Status : Completed
First Posted : February 11, 2014
Results First Posted : January 28, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
University of Utah
Vanderbilt-Ingram Cancer Center
Johns Hopkins University
Thomas Jefferson University
Washington University School of Medicine
Northwestern University
City of Hope Comprehensive Cancer Center
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Ibrance
Drug: Bicalutamide
Drug: Zoladex
Drug: Lupron Depot
Enrollment 72
Recruitment Details  
Pre-assignment Details 72 patients were enrolled to the trial. Seven patients did not have adequate tissue for testing retinoblastoma status. Two patients tested negative for retinoblastoma and one patient was found to have small cell metastasis and not adenocarcinoma. 62 patients were randomized.
Arm/Group Title ADT Alone ADT + Ibrance®
Hide Arm/Group Description Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection). Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Period Title: Overall Study
Started 20 42
Initiated Treatment 20 40
Completed 20 40
Not Completed 0 2
Arm/Group Title ADT Alone ADT + Ibrance® Total
Hide Arm/Group Description Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection). Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection). Total of all reporting groups
Overall Number of Baseline Participants 20 42 62
Hide Baseline Analysis Population Description
62 out of 72 patients enrolled had adequate tissue for RB assessment and retained RB expression. (60 patients initiated treatment.)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 42 participants 62 participants
67.5
(44 to 81)
67.5
(47 to 87)
67.5
(44 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 42 participants 62 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
42
 100.0%
62
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 42 participants 62 participants
Hispanic or Latino
3
  15.0%
2
   4.8%
5
   8.1%
Not Hispanic or Latino
16
  80.0%
39
  92.9%
55
  88.7%
Unknown or Not Reported
1
   5.0%
1
   2.4%
2
   3.2%
1.Primary Outcome
Title Number of Patients Who Achieve a PSA ≤ 4ng/mL After Seven Months of Protocol Treatment in Each Arm
Hide Description The primary analysis will be assessment of the proportion of patients who achieve a (Prostate-specific antigen) PSA < 4ng/mL after seven months of protocol treatment in each arm.
Time Frame 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
72 patients were enrolled to the trial. Seven patients did not have adequate tissue for testing retinoblastoma status. Two patients tested negative for retinoblastoma and one patient was found to have small cell metastasis and not adenocarcinoma. 62 patients were randomized. 60 randomized patients initiated therapy on trial.
Arm/Group Title ADT Alone ADT + Ibrance®
Hide Arm/Group Description:
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Overall Number of Participants Analyzed 20 40
Measure Type: Count of Participants
Unit of Measure: Participants
16
  80.0%
32
  80.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADT Alone, ADT + Ibrance®
Comments With 20 patients treated with ADT and 40 treated with ADT + palbociclib there is a 64.2% power to detect a 20% difference in proportions with a one-sided type I error of 0.10 using the mid p-value method of the Fisher's exact test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Fisher Exact
Comments Mid P-value
2.Secondary Outcome
Title Number of Participants With Grade >=3 Adverse Events That Are Possibly, Probably or Definitely Related to Study Treatment
Hide Description Grade >=3 adverse events that are possibly, probably or definitely related to study treatment, reported by number of participants affected in each arm
Time Frame Up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADT Alone ADT + Ibrance®
Hide Arm/Group Description:
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Overall Number of Participants Analyzed 20 40
Measure Type: Number
Unit of Measure: participants
0 23
3.Secondary Outcome
Title Duration of Therapy
Hide Description Duration of therapy will be reported to describe tolerability within each arm.
Time Frame Up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADT Alone ADT + Ibrance®
Hide Arm/Group Description:
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Overall Number of Participants Analyzed 20 40
Mean (Standard Deviation)
Unit of Measure: months
22.4  (13.1) 22.0  (13.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADT Alone, ADT + Ibrance®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Patients Who Achieve Undetectable PSA (<0.2ng/mL)
Hide Description [Not Specified]
Time Frame Up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADT Alone ADT + Ibrance®
Hide Arm/Group Description:

Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).

Bicalutamide

Zoladex

Lupron Depot

Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).

Ibrance

Bicalutamide

Zoladex

Lupron Depot

Overall Number of Participants Analyzed 20 40
Measure Type: Count of Participants
Unit of Measure: Participants
13
  65.0%
22
  55.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADT Alone, ADT + Ibrance®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Fisher Exact
Comments Mid p-value
5.Secondary Outcome
Title Biochemical Progression-free Survival Rate
Hide Description 12-month biochemical progression-free survival rate will begin from treatment start until the event of biochemical (PSA) progression or death, whichever occurs first. Described by arm using Kaplan-Meier methods.
Time Frame Up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADT Alone ADT + Ibrance®
Hide Arm/Group Description:
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Overall Number of Participants Analyzed 20 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12-month
74.7
(49.4 to 88.6)
76.5
(59.6 to 87)
26-month (time of last event in Arm 1)
45.8
(22.4 to 66.6)
59.4
(41.7 to 73.3)
43-month (time of last event in Arm 2)
45.8
(22.4 to 66.6)
33.9
(8.9 to 61.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADT Alone, ADT + Ibrance®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Clinical Progression-free Survival Rate
Hide Description 12-month clinical progression-free survival rate will begin from treatment start until the event of biochemical (PSA) progression or death, whichever occurs first. Described by arm using Kaplan-Meier methods.
Time Frame Up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADT Alone ADT + Ibrance®
Hide Arm/Group Description:
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Overall Number of Participants Analyzed 20 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12-month
77.7
(51.1 to 91)
83.8
(67.4 to 92.4)
22-month (time of last event in Arm 1)
64.8
(37.5 to 82.5)
77.7
(60.2 to 88.2)
32-month (time of last event in Arm 2)
64.8
(37.5 to 82.5)
58.5
(33.9 to 76.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADT Alone, ADT + Ibrance®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Frequency of Dose Modification
Hide Description Dose modifications will be reported to describe tolerability for arm 2 only (Ibrance®)
Time Frame Up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADT + Ibrance®
Hide Arm/Group Description:
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
No Dose Reduction (Palbociclib 125mg/day) 28
1 Dose Reduction, to Palbociclib 100mg/day 5
2 Dose Reductions, to Palbociclib 75mg/day 7
8.Secondary Outcome
Title Frequency of Treatment Delay
Hide Description Treatment delays will be reported to describe tolerability within each arm.
Time Frame Up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADT Alone ADT + Ibrance®
Hide Arm/Group Description:
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Overall Number of Participants Analyzed 20 40
Measure Type: Number
Unit of Measure: participants
No Treatment delay of Bicalutamide 19 35
Treatment Delay of Bicalutamide 1 5
No Treatment Delay of Palbociclib 0 21
Treatment Delay of Palbociclib 0 19
Time Frame Adverse events (AEs) were collected up to 44 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADT Alone ADT + Ibrance®
Hide Arm/Group Description Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection). Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
All-Cause Mortality
ADT Alone ADT + Ibrance®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      1/40 (2.50%)    
Hide Serious Adverse Events
ADT Alone ADT + Ibrance®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/20 (25.00%)      7/40 (17.50%)    
Cardiac disorders     
Aortic valve disease   0/20 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders     
Abdominal pain   0/20 (0.00%)  0 1/40 (2.50%)  1
Pancreatitis   0/20 (0.00%)  0 1/40 (2.50%)  1
Small intestinal obstruction   1/20 (5.00%)  1 0/40 (0.00%)  0
Vomiting   0/20 (0.00%)  0 1/40 (2.50%)  1
General disorders     
Fever   1/20 (5.00%)  1 0/40 (0.00%)  0
General disorders and administration site conditions - Other, specify   1/20 (5.00%)  1 0/40 (0.00%)  0
Infections and infestations     
Sepsis   1/20 (5.00%)  1 0/40 (0.00%)  0
Urinary tract infection   1/20 (5.00%)  1 0/40 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration   0/20 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Back pain   0/20 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders     
Syncope   0/20 (0.00%)  0 1/40 (2.50%)  1
Renal and urinary disorders     
Acute kidney injury   1/20 (5.00%)  1 0/40 (0.00%)  0
Urinary retention   0/20 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxia   1/20 (5.00%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify   0/20 (0.00%)  0 1/40 (2.50%)  1
Vascular disorders     
Hematoma   0/20 (0.00%)  0 1/40 (2.50%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ADT Alone ADT + Ibrance®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/20 (100.00%)      40/40 (100.00%)    
Blood and lymphatic system disorders     
Anemia   4/20 (20.00%)  5 13/40 (32.50%)  23
Blood and lymphatic system disorders - Other   1/20 (5.00%)  1 3/40 (7.50%)  5
Bone marrow hypocellular   0/20 (0.00%)  0 1/40 (2.50%)  1
Lymph node pain   0/20 (0.00%)  0 1/40 (2.50%)  1
Cardiac disorders     
Aortic valve disease   0/20 (0.00%)  0 1/40 (2.50%)  1
Cardiac disorders - Other   1/20 (5.00%)  1 1/40 (2.50%)  1
Chest pain - cardiac   0/20 (0.00%)  0 1/40 (2.50%)  1
Left ventricular systolic dysfunction   0/20 (0.00%)  0 1/40 (2.50%)  1
Sinus bradycardia   2/20 (10.00%)  2 2/40 (5.00%)  2
Ear and labyrinth disorders     
Ear and labyrinth disorders - Other   1/20 (5.00%)  1 2/40 (5.00%)  2
Hearing impaired   1/20 (5.00%)  1 4/40 (10.00%)  4
Tinnitus   0/20 (0.00%)  0 1/40 (2.50%)  1
Vertigo   1/20 (5.00%)  1 2/40 (5.00%)  2
Vestibular disorder   1/20 (5.00%)  1 0/40 (0.00%)  0
Eye disorders     
Blurred vision   0/20 (0.00%)  0 3/40 (7.50%)  3
Dry eye   1/20 (5.00%)  1 1/40 (2.50%)  1
Eye disorders - Other   1/20 (5.00%)  1 3/40 (7.50%)  4
Eye pain   0/20 (0.00%)  0 1/40 (2.50%)  1
Glaucoma   0/20 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders     
Abdominal pain   2/20 (10.00%)  3 6/40 (15.00%)  6
Bloating   2/20 (10.00%)  2 0/40 (0.00%)  0
Constipation   2/20 (10.00%)  2 14/40 (35.00%)  18
Dental caries   1/20 (5.00%)  1 5/40 (12.50%)  5
Diarrhea   2/20 (10.00%)  2 10/40 (25.00%)  12
Dry mouth   2/20 (10.00%)  2 3/40 (7.50%)  3
Dyspepsia   1/20 (5.00%)  3 1/40 (2.50%)  1
Dysphagia   0/20 (0.00%)  0 2/40 (5.00%)  2
Fecal incontinence   0/20 (0.00%)  0 2/40 (5.00%)  2
Flatulence   0/20 (0.00%)  0 3/40 (7.50%)  3
Gastroesophageal reflux disease   0/20 (0.00%)  0 4/40 (10.00%)  4
Gastrointestinal disorders - Other   2/20 (10.00%)  2 8/40 (20.00%)  8
Gastrointestinal pain   0/20 (0.00%)  0 1/40 (2.50%)  1
Hemorrhoidal hemorrhage   0/20 (0.00%)  0 1/40 (2.50%)  1
Hemorrhoids   0/20 (0.00%)  0 1/40 (2.50%)  1
Mucositis oral   0/20 (0.00%)  0 1/40 (2.50%)  1
Nausea   4/20 (20.00%)  6 9/40 (22.50%)  13
Oral pain   0/20 (0.00%)  0 1/40 (2.50%)  1
Rectal hemorrhage   1/20 (5.00%)  1 0/40 (0.00%)  0
Stomach pain   1/20 (5.00%)  1 0/40 (0.00%)  0
Toothache   1/20 (5.00%)  1 2/40 (5.00%)  2
Vomiting   2/20 (10.00%)  3 5/40 (12.50%)  17
General disorders     
Chills   0/20 (0.00%)  0 5/40 (12.50%)  5
Edema limbs   7/20 (35.00%)  8 9/40 (22.50%)  11
Fatigue   12/20 (60.00%)  16 23/40 (57.50%)  29
Fever   1/20 (5.00%)  2 0/40 (0.00%)  0
Flu like symptoms   3/20 (15.00%)  6 6/40 (15.00%)  10
Gait disturbance   1/20 (5.00%)  1 1/40 (2.50%)  1
General disorders and administration site conditions - Other   2/20 (10.00%)  3 8/40 (20.00%)  10
Injection site reaction   0/20 (0.00%)  0 3/40 (7.50%)  3
Irritability   2/20 (10.00%)  2 1/40 (2.50%)  1
Non-cardiac chest pain   1/20 (5.00%)  1 2/40 (5.00%)  2
Pain   4/20 (20.00%)  7 12/40 (30.00%)  17
Hepatobiliary disorders     
Cholecystitis   0/20 (0.00%)  0 1/40 (2.50%)  1
Immune system disorders     
Allergic reaction   0/20 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations     
Infections and infestations - Other   2/20 (10.00%)  2 0/40 (0.00%)  0
Lip infection   0/20 (0.00%)  0 1/40 (2.50%)  1
Nail infection   1/20 (5.00%)  1 0/40 (0.00%)  0
Otitis externa   0/20 (0.00%)  0 1/40 (2.50%)  1
Papulopustular rash   0/20 (0.00%)  0 1/40 (2.50%)  1
Pharyngitis   2/20 (10.00%)  2 1/40 (2.50%)  1
Scrotal infection   1/20 (5.00%)  1 0/40 (0.00%)  0
Sinusitis   2/20 (10.00%)  5 1/40 (2.50%)  1
Skin infection   0/20 (0.00%)  0 1/40 (2.50%)  1
Tooth infection   0/20 (0.00%)  0 2/40 (5.00%)  2
Upper respiratory infection   2/20 (10.00%)  2 9/40 (22.50%)  14
Urinary tract infection   1/20 (5.00%)  1 4/40 (10.00%)  5
Injury, poisoning and procedural complications     
Aortic injury   0/20 (0.00%)  0 1/40 (2.50%)  1
Bruising   0/20 (0.00%)  0 5/40 (12.50%)  5
Burn   0/20 (0.00%)  0 1/40 (2.50%)  1
Fall   1/20 (5.00%)  1 3/40 (7.50%)  3
Fracture   1/20 (5.00%)  2 2/40 (5.00%)  2
Injury, poisoning and procedural complications - Other   2/20 (10.00%)  2 1/40 (2.50%)  1
Seroma   0/20 (0.00%)  0 1/40 (2.50%)  1
Spinal fracture   1/20 (5.00%)  1 0/40 (0.00%)  0
Investigations     
Alanine aminotransferase increased   4/20 (20.00%)  5 5/40 (12.50%)  7
Alkaline phosphatase increased   1/20 (5.00%)  2 4/40 (10.00%)  4
Aspartate aminotransferase increased   3/20 (15.00%)  4 6/40 (15.00%)  9
Blood bilirubin increased   1/20 (5.00%)  1 1/40 (2.50%)  2
Cholesterol high   0/20 (0.00%)  0 1/40 (2.50%)  1
Creatinine increased   3/20 (15.00%)  5 3/40 (7.50%)  6
Electrocardiogram QT corrected interval prolonged   0/20 (0.00%)  0 2/40 (5.00%)  2
Investigations - Other   2/20 (10.00%)  2 3/40 (7.50%)  4
Lipase increased   0/20 (0.00%)  0 1/40 (2.50%)  1
Lymphocyte count decreased   1/20 (5.00%)  1 6/40 (15.00%)  12
Neutrophil count decreased   0/20 (0.00%)  0 25/40 (62.50%)  96
Platelet count decreased   0/20 (0.00%)  0 14/40 (35.00%)  29
Weight gain   6/20 (30.00%)  12 7/40 (17.50%)  10
Weight loss   2/20 (10.00%)  2 3/40 (7.50%)  6
White blood cell decreased   1/20 (5.00%)  1 19/40 (47.50%)  65
Metabolism and nutrition disorders     
Anorexia   0/20 (0.00%)  0 1/40 (2.50%)  2
Dehydration   1/20 (5.00%)  1 1/40 (2.50%)  1
Hypercalcemia   4/20 (20.00%)  4 3/40 (7.50%)  3
Hyperglycemia   4/20 (20.00%)  13 15/40 (37.50%)  36
Hyperkalemia   2/20 (10.00%)  3 4/40 (10.00%)  4
Hypermagnesemia   0/20 (0.00%)  0 1/40 (2.50%)  1
Hypernatremia   1/20 (5.00%)  2 1/40 (2.50%)  4
Hypertriglyceridemia   1/20 (5.00%)  1 0/40 (0.00%)  0
Hypoalbuminemia   1/20 (5.00%)  1 0/40 (0.00%)  0
Hypoglycemia   1/20 (5.00%)  3 0/40 (0.00%)  0
Hypomagnesemia   1/20 (5.00%)  1 3/40 (7.50%)  3
Hyponatremia   1/20 (5.00%)  2 1/40 (2.50%)  2
Hypophosphatemia   4/20 (20.00%)  5 7/40 (17.50%)  11
Metabolism and nutrition disorders - Other   1/20 (5.00%)  1 2/40 (5.00%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia   6/20 (30.00%)  8 5/40 (12.50%)  9
Arthritis   3/20 (15.00%)  4 4/40 (10.00%)  6
Back pain   5/20 (25.00%)  9 9/40 (22.50%)  14
Bone pain   1/20 (5.00%)  1 7/40 (17.50%)  8
Buttock pain   1/20 (5.00%)  1 0/40 (0.00%)  0
Flank pain   0/20 (0.00%)  0 3/40 (7.50%)  3
Generalized muscle weakness   1/20 (5.00%)  1 5/40 (12.50%)  7
Joint range of motion decreased   1/20 (5.00%)  1 0/40 (0.00%)  0
Muscle weakness lower limb   0/20 (0.00%)  0 1/40 (2.50%)  1
Muscle weakness upper limb   0/20 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other   3/20 (15.00%)  6 8/40 (20.00%)  10
Myalgia   1/20 (5.00%)  1 8/40 (20.00%)  12
Neck pain   1/20 (5.00%)  3 3/40 (7.50%)  3
Osteonecrosis of jaw   0/20 (0.00%)  0 1/40 (2.50%)  1
Osteoporosis   1/20 (5.00%)  1 1/40 (2.50%)  1
Pain in extremity   7/20 (35.00%)  7 4/40 (10.00%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other   1/20 (5.00%)  2 1/40 (2.50%)  1
Nervous system disorders     
Akathisia   0/20 (0.00%)  0 1/40 (2.50%)  1
Amnesia   0/20 (0.00%)  0 1/40 (2.50%)  1
Cognitive disturbance   0/20 (0.00%)  0 1/40 (2.50%)  1
Concentration impairment   1/20 (5.00%)  1 2/40 (5.00%)  2
Dizziness   4/20 (20.00%)  5 9/40 (22.50%)  13
Dysgeusia   0/20 (0.00%)  0 3/40 (7.50%)  5
Headache   2/20 (10.00%)  2 6/40 (15.00%)  8
Lethargy   0/20 (0.00%)  0 1/40 (2.50%)  1
Memory impairment   1/20 (5.00%)  1 2/40 (5.00%)  2
Nervous system disorders - Other   1/20 (5.00%)  1 1/40 (2.50%)  1
Paresthesia   3/20 (15.00%)  5 3/40 (7.50%)  4
Peripheral motor neuropathy   0/20 (0.00%)  0 1/40 (2.50%)  1
Peripheral sensory neuropathy   1/20 (5.00%)  1 6/40 (15.00%)  7
Presyncope   0/20 (0.00%)  0 1/40 (2.50%)  1
Radiculitis   0/20 (0.00%)  0 1/40 (2.50%)  1
Somnolence   0/20 (0.00%)  0 1/40 (2.50%)  1
Syncope   2/20 (10.00%)  3 0/40 (0.00%)  0
Tremor   0/20 (0.00%)  0 2/40 (5.00%)  2
Psychiatric disorders     
Anxiety   3/20 (15.00%)  3 3/40 (7.50%)  4
Depression   3/20 (15.00%)  3 8/40 (20.00%)  10
Insomnia   4/20 (20.00%)  4 9/40 (22.50%)  9
Libido decreased   2/20 (10.00%)  2 0/40 (0.00%)  0
Psychiatric disorders - Other   3/20 (15.00%)  4 2/40 (5.00%)  2
Renal and urinary disorders     
Acute kidney injury   0/20 (0.00%)  0 1/40 (2.50%)  1
Chronic kidney disease   0/20 (0.00%)  0 1/40 (2.50%)  1
Cystitis noninfective   2/20 (10.00%)  2 2/40 (5.00%)  2
Hematuria   3/20 (15.00%)  3 3/40 (7.50%)  4
Proteinuria   0/20 (0.00%)  0 1/40 (2.50%)  1
Renal and urinary disorders - Other   1/20 (5.00%)  1 2/40 (5.00%)  2
Renal calculi   0/20 (0.00%)  0 1/40 (2.50%)  1
Urinary frequency   3/20 (15.00%)  3 7/40 (17.50%)  7
Urinary incontinence   0/20 (0.00%)  0 2/40 (5.00%)  2
Urinary retention   1/20 (5.00%)  1 0/40 (0.00%)  0
Urinary tract obstruction   0/20 (0.00%)  0 1/40 (2.50%)  1
Urinary tract pain   2/20 (10.00%)  2 2/40 (5.00%)  2
Urinary urgency   0/20 (0.00%)  0 2/40 (5.00%)  2
Reproductive system and breast disorders     
Breast pain   1/20 (5.00%)  2 1/40 (2.50%)  1
Erectile dysfunction   2/20 (10.00%)  2 3/40 (7.50%)  3
Gynecomastia   4/20 (20.00%)  4 8/40 (20.00%)  8
Pelvic pain   0/20 (0.00%)  0 2/40 (5.00%)  2
Reproductive system and breast disorders - Other   0/20 (0.00%)  0 2/40 (5.00%)  2
Testicular pain   1/20 (5.00%)  1 3/40 (7.50%)  3
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis   2/20 (10.00%)  5 6/40 (15.00%)  6
Atelectasis   0/20 (0.00%)  0 1/40 (2.50%)  1
Cough   4/20 (20.00%)  5 16/40 (40.00%)  19
Dyspnea   2/20 (10.00%)  2 9/40 (22.50%)  9
Epistaxis   0/20 (0.00%)  0 4/40 (10.00%)  5
Hoarseness   0/20 (0.00%)  0 1/40 (2.50%)  1
Laryngeal inflammation   0/20 (0.00%)  0 1/40 (2.50%)  1
Nasal congestion   1/20 (5.00%)  1 6/40 (15.00%)  6
Postnasal drip   0/20 (0.00%)  0 1/40 (2.50%)  1
Productive cough   0/20 (0.00%)  0 3/40 (7.50%)  7
Respiratory, thoracic and mediastinal disorders - Other   1/20 (5.00%)  1 3/40 (7.50%)  4
Sinus disorder   1/20 (5.00%)  1 0/40 (0.00%)  0
Sleep apnea   0/20 (0.00%)  0 2/40 (5.00%)  2
Sneezing   0/20 (0.00%)  0 1/40 (2.50%)  1
Sore throat   2/20 (10.00%)  3 5/40 (12.50%)  7
Skin and subcutaneous tissue disorders     
Alopecia   4/20 (20.00%)  4 10/40 (25.00%)  10
Dry skin   1/20 (5.00%)  1 5/40 (12.50%)  5
Nail loss   0/20 (0.00%)  0 2/40 (5.00%)  2
Palmar-plantar erythrodysesthesia syndrome   0/20 (0.00%)  0 2/40 (5.00%)  3
Photosensitivity   1/20 (5.00%)  1 0/40 (0.00%)  0
Pruritus   1/20 (5.00%)  1 1/40 (2.50%)  1
Rash acneiform   0/20 (0.00%)  0 2/40 (5.00%)  5
Rash maculo-papular   1/20 (5.00%)  1 2/40 (5.00%)  3
Scalp pain   0/20 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other   4/20 (20.00%)  6 10/40 (25.00%)  13
Skin atrophy   0/20 (0.00%)  0 1/40 (2.50%)  1
Surgical and medical procedures     
Surgical and medical procedures - Other   0/20 (0.00%)  0 1/40 (2.50%)  1
Vascular disorders     
Flushing   0/20 (0.00%)  0 1/40 (2.50%)  1
Hot flashes   16/20 (80.00%)  19 31/40 (77.50%)  36
Hypertension   2/20 (10.00%)  2 8/40 (20.00%)  17
Hypotension   1/20 (5.00%)  1 0/40 (0.00%)  0
Thromboembolic event   0/20 (0.00%)  0 2/40 (5.00%)  2
Vascular disorders - Other   1/20 (5.00%)  1 1/40 (2.50%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Phillip Palmbos, M.D., Ph.D.
Organization: University of Michigan Rogel Cancer Center
Phone: 734-936-3591
EMail: ppalmbos@umich.edu
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02059213    
Other Study ID Numbers: UMCC 2013.117
HUM00082715 ( Other Identifier: University of Michigan )
First Submitted: February 7, 2014
First Posted: February 11, 2014
Results First Submitted: December 5, 2018
Results First Posted: January 28, 2019
Last Update Posted: September 16, 2020