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Trial record 1 of 2 for:    johns hopkins AND mpx AND cancer
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Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01317199
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
Howard University
Prostate Cancer Clinical Trials Consortium
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Muscadine Plus Grape Skin Extract
Drug: Low-dose MPX
Drug: High-dose MPX
Drug: Placebo oral capsule
Enrollment 143
Recruitment Details

Recruitment dates:

Phase I: October 4, 2011-August 7, 2012 in medical clinics Phase II: January 31, 2013-October 20, 2014

Pre-assignment Details

Enrolled subjects agreed to abstain from other commercially available Muscadine Plus products while in this trial.

If subjects were taking other dietary/herbal supplements (e.g. saw palmetto, selenium, pomegranate juice or pills, etc) prior to study entry, they had to be on a stable dose for 2 months prior and not stop while on trial.

Arm/Group Title Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX) Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Hide Arm/Group Description Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle. Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle). Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Period Title: Dose-escalation Phase 1
Started 14 0 0 0
Cycle 1: 500mg MPX Once Daily for 28 Day 2 0 0 0
Cycle 2: 1000mg MPX Daily for 28 Days 2 0 0 0
Cycle 3: 2000mg MPX Daily for 28 Days 2 0 0 0
Cycle 4: 3000mg MPX Daily for 28 Days 2 0 0 0
Cycle 5: 4000mg MPX Daily for 28 Days 6 0 0 0
Completed 7 0 0 0
Not Completed 7 0 0 0
Reason Not Completed
Physician Decision             5             0             0             0
Disease progression             1             0             0             0
Comorbidities, myasthenia gravis             1             0             0             0
Period Title: Randomized Phase 2
Started 0 24 56 49
Completed 0 13 35 32
Not Completed 0 11 21 17
Reason Not Completed
Disease progression             0             3             7             5
Withdrawal by Subject             0             3             5             4
Adverse Event             0             0             0             1
Comorbidities             0             2             2             2
Rising PSA, not as defined by protocol             0             2             5             2
Disenrolled before treatment             0             1             1             2
Patient stopped taking study drug             0             0             0             1
Patient transferred to other facility             0             0             1             0
Arm/Group Title Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX) Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX Total
Hide Arm/Group Description Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle. Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle). Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle). Total of all reporting groups
Overall Number of Baseline Participants 14 24 56 49 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 24 participants 56 participants 49 participants 143 participants
62.6  (7.5) 69  (7.1) 67  (7.2) 68  (6.9) 67.2  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 24 participants 56 participants 49 participants 143 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
14
 100.0%
24
 100.0%
56
 100.0%
49
 100.0%
143
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 24 participants 56 participants 49 participants 143 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  28.6%
6
  25.0%
12
  21.4%
10
  20.4%
32
  22.4%
White
10
  71.4%
18
  75.0%
43
  76.8%
38
  77.6%
109
  76.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.8%
1
   2.0%
2
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 24 participants 56 participants 49 participants 143 participants
14 24 56 49 143
Eastern Cooperative Oncology Group (ECOG)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 23 participants 54 participants 47 participants 124 participants
0
18
  78.3%
52
  96.3%
39
  83.0%
109
  87.9%
1
5
  21.7%
2
   3.7%
8
  17.0%
15
  12.1%
[1]
Measure Description: The Eastern Cooperative Oncology Group (ECOG) scale is a measure of performance status with 0 (fully active) as the best score and 1 being restricted to physically strenuous activity.
[2]
Measure Analysis Population Description: Baseline characteristics were not collected for subjects who withdrew from the study. ECOG was not analyzed in the dose-escalation phase.
Gleason score   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
≤6, 3+4 Number Analyzed 0 participants 24 participants 56 participants 49 participants 129 participants
11
  45.8%
25
  44.6%
23
  46.9%
59
  45.7%
≥8, 4+3 Number Analyzed 0 participants 24 participants 56 participants 49 participants 129 participants
13
  54.2%
31
  55.4%
26
  53.1%
70
  54.3%
6 Number Analyzed 14 participants 0 participants 0 participants 0 participants 14 participants
3
  21.4%
3
  21.4%
7 Number Analyzed 14 participants 0 participants 0 participants 0 participants 14 participants
7
  50.0%
7
  50.0%
8 Number Analyzed 14 participants 0 participants 0 participants 0 participants 14 participants
1
   7.1%
1
   7.1%
9 Number Analyzed 14 participants 0 participants 0 participants 0 participants 14 participants
3
  21.4%
3
  21.4%
[1]
Measure Description: The gleason score is an indication of prognosis based on prostate pathology. The score ranges from 2 to 10 with a higher score reflecting less-differentiated tumors with worse prognosis. The total score is a sum of two numbers which are based on the microscopic appearance of cells. The first number is the score based on the dominant, cell morphology (scored 1-5) and the second number is based on the highest grade of the non-dominant cell pattern (scored 1-5).
[2]
Measure Analysis Population Description: Gleason score was recorded differently in the dose-escalation phase and phase 2.
Baseline PSA doubling time (PSADT)   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 14 participants 0 participants 0 participants 0 participants 14 participants
13  (10.1) 13  (10.1)
[1]
Measure Analysis Population Description: Baseline PSADT was recorded as a mean in the dose-escalation phase, versus as number of participants with greater than or less than 9 months PSADT in Phase 2.
Baseline PSADT   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 23 participants 55 participants 48 participants 126 participants
≤9 months
13
  56.5%
32
  58.2%
27
  56.3%
72
  57.1%
>9 months
10
  43.5%
23
  41.8%
21
  43.8%
54
  42.9%
[1]
Measure Analysis Population Description: Baseline PSADT was recorded as a mean in the dose-escalation phase, versus as number of participants with greater than or less than 9 months PSADT in Phase 2.
Prior therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Radiation Number Analyzed 14 participants 24 participants 56 participants 49 participants 143 participants
4
  28.6%
21
  87.5%
49
  87.5%
42
  85.7%
116
  81.1%
Surgery Number Analyzed 14 participants 24 participants 56 participants 49 participants 143 participants
1
   7.1%
16
  66.7%
40
  71.4%
32
  65.3%
89
  62.2%
Radiation & Surgery Number Analyzed 14 participants 0 participants 0 participants 0 participants 14 participants
9
  64.3%
9
  64.3%
Cryotherapy Number Analyzed 0 participants 24 participants 56 participants 49 participants 129 participants
0
   0.0%
49
  87.5%
1
   2.0%
50
  38.8%
Brachytherapy Number Analyzed 0 participants 24 participants 56 participants 49 participants 129 participants
3
  12.5%
5
   8.9%
3
   6.1%
11
   8.5%
Androgen Deprivation Therapy (ADT) Number Analyzed 0 participants 24 participants 56 participants 49 participants 129 participants
2
   8.3%
25
  44.6%
19
  38.8%
46
  35.7%
[1]
Measure Analysis Population Description: Participants in Phase 2 were not categorized as 'Radiation & Surgery'. Only individual counts for each prior therapy received was recorded.
Superoxide dismutase 2 (SOD2) genotype   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Alanine/Alanine (Ala/Ala) Number Analyzed 0 participants 21 participants 44 participants 37 participants 102 participants
5
  23.8%
12
  27.3%
10
  27.0%
27
  26.5%
Alanine/Valine (Ala/Val) Number Analyzed 0 participants 24 participants 56 participants 49 participants 129 participants
11
  45.8%
21
  37.5%
22
  44.9%
54
  41.9%
Valine/Valine (Val/Val) Number Analyzed 0 participants 24 participants 56 participants 49 participants 129 participants
5
  20.8%
11
  19.6%
5
  10.2%
21
  16.3%
[1]
Measure Analysis Population Description: SOD2 genotype was not recorded in dose-escalation phase. In Phase 2, SOD2 genotype was not recorded for all participants if data was unavailable.
1.Primary Outcome
Title (Phase I) Maximum Tolerated Dose
Hide Description To determine the recommended dosing for Muscadine Plus and to evaluate the safety and tolerability of Muscadine Plus in prostate cancer patients with rising PSA following definitive therapy.
Time Frame Up to 7 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX) Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Hide Arm/Group Description:
Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Overall Number of Participants Analyzed 14 0 0 0
Measure Type: Number
Unit of Measure: mg
4000
2.Primary Outcome
Title (Phase II) Prostate Specific Antigen Doubling Time (PSADT)
Hide Description To define the effects of placebo and two different daily doses of MPX on PSADT in men who have rising PSA after initial definitive therapy for localized prostate cancer.
Time Frame Change from baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Hide Arm/Group Description:
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Overall Number of Participants Analyzed 20 52 40
Median (Full Range)
Unit of Measure: months
0.9
(-6.7 to 83.1)
1.5
(-10.3 to 87.2)
0.9
(-27.3 to 88.1)
3.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description Adverse events reported verbally by patient and documented in study notes.
Time Frame At month 12 post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX) Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Hide Arm/Group Description:
Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Overall Number of Participants Analyzed 14 23 55 47
Measure Type: Count of Participants
Unit of Measure: Participants
7
  50.0%
19
  82.6%
38
  69.1%
32
  68.1%
4.Secondary Outcome
Title (Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%
Hide Description [Not Specified]
Time Frame At month 12 post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this secondary outcome measure.
Arm/Group Title Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Hide Arm/Group Description:
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title (Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline
Hide Description Change in PSA values drawn over study period, taken every 3 months. PSA is measured in ng/mL
Time Frame At month 12 post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Patients counted in the analysis were evaluable if they completed at least six cycles of treatment prior to discontinuation
Arm/Group Title Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Hide Arm/Group Description:
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Overall Number of Participants Analyzed 20 52 40
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   2.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg Dose-escalation Phase 1: MPX 1000mg Dose-escalation Phase 1: MPX 2000mg Dose-escalation Phase 1: MPX 3000mg Dose-escalation Phase 1: MPX 4000mg Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Hide Arm/Group Description Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle. Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle. Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle. Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle. Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle. Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle). Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
All-Cause Mortality
Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg Dose-escalation Phase 1: MPX 1000mg Dose-escalation Phase 1: MPX 2000mg Dose-escalation Phase 1: MPX 3000mg Dose-escalation Phase 1: MPX 4000mg Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      0/6 (0.00%)      0/23 (0.00%)      0/55 (0.00%)      0/47 (0.00%)    
Hide Serious Adverse Events
Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg Dose-escalation Phase 1: MPX 1000mg Dose-escalation Phase 1: MPX 2000mg Dose-escalation Phase 1: MPX 3000mg Dose-escalation Phase 1: MPX 4000mg Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      0/6 (0.00%)      0/23 (0.00%)      1/55 (1.82%)      1/47 (2.13%)    
Infections and infestations                 
Cellulitis  [1]  0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0 0/23 (0.00%)  0 1/55 (1.82%)  1 0/47 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Vocal Chord Squamous Cell Carcinoma  [2]  0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0 0/23 (0.00%)  0 0/55 (0.00%)  0 1/47 (2.13%)  1
Indicates events were collected by systematic assessment
[1]
Unrelated to study drug.
[2]
Unrelated to study drug
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg Dose-escalation Phase 1: MPX 1000mg Dose-escalation Phase 1: MPX 2000mg Dose-escalation Phase 1: MPX 3000mg Dose-escalation Phase 1: MPX 4000mg Phase 2: Placebo Control Phase 2: Low-dose MPX Phase 2: High-dose MPX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      1/2 (50.00%)      0/2 (0.00%)      0/2 (0.00%)      3/6 (50.00%)      3/23 (13.04%)      10/55 (18.18%)      7/47 (14.89%)    
Gastrointestinal disorders                 
Flatulence  [1]  0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 3/6 (50.00%)  3 3/23 (13.04%)  3 6/55 (10.91%)  6 3/47 (6.38%)  3
Diarrhea   0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0 0/23 (0.00%)  0 4/55 (7.27%)  4 0/47 (0.00%)  0
dyspepsia   0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0 0/23 (0.00%)  0 0/55 (0.00%)  0 4/47 (8.51%)  4
Indicates events were collected by systematic assessment
[1]
Related to study drug
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: Dr. Channing Paller
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8239
EMail: cpaller1@jhmi.edu
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01317199    
Other Study ID Numbers: J1161
First Submitted: March 11, 2011
First Posted: March 17, 2011
Results First Submitted: May 14, 2018
Results First Posted: July 18, 2018
Last Update Posted: July 18, 2018