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Tivantinib in Treating Patients With Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01519414
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Hormone-Resistant Prostate Cancer
Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Interventions Other: Laboratory Biomarker Analysis
Other: Placebo
Drug: Tivantinib
Enrollment 78

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Tivantinib) Arm II (Placebo) Crossover From Placebo to Tivantinib
Hide Arm/Group Description Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.
Period Title: Pre Cross-over
Started 52 26 0
Completed 52 26 0
Not Completed 0 0 0
Period Title: Post Cross-over
Started 52 14 12
Completed 52 14 12
Not Completed 0 0 0
Arm/Group Title Arm I (Tivantinib) Arm II (Placebo) Total
Hide Arm/Group Description Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. Total of all reporting groups
Overall Number of Baseline Participants 52 26 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants 26 participants 78 participants
67
(43 to 84)
66.5
(48 to 85)
67
(43 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 26 participants 78 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
52
 100.0%
26
 100.0%
78
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 26 participants 78 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.9%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   3.8%
6
  23.1%
8
  10.3%
White
49
  94.2%
20
  76.9%
69
  88.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Patients
United States Number Analyzed 52 participants 26 participants 78 participants
52 26 78
1.Primary Outcome
Title Progression-free Survival (PFS) Based on the RECIST Criteria
Hide Description The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.
Time Frame Time from study entry to the date of documented progression and/or death, assessed up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Tivantinib) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
Overall Number of Participants Analyzed 52 26
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(3.2 to 8.0)
3.7
(2.7 to 5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Tivantinib), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Changes in PSA Levels
Hide Description Evaluated and patterns graphically explored through waterfall plots.
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Tivantinib) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
Overall Number of Participants Analyzed 52 26
Median (Full Range)
Unit of Measure: percentage change from baseline
140.1
(-9.0 to 5768.1)
301.5
(-3.3 to 3254.4)
3.Secondary Outcome
Title Proportion of Patients Who Respond
Hide Description An assumed binomial distribution used. Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.
Time Frame At 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Tivantinib) Arm II (Placebo) Crossover From Placebo to Tivantinib
Hide Arm/Group Description:
Arm I: Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to
Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.
Overall Number of Participants Analyzed 52 26 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
1.9
(0.05 to 10.26)
0
(0 to 0)
8.3
(0.2 to 38.5)
4.Secondary Outcome
Title PSA Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Tivantinib) Arm II (Placebo) Crossover From Placebo to Tivantinib
Hide Arm/Group Description:
Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.
Overall Number of Participants Analyzed 52 26 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
1.9
(0.05 to 10.26)
0
(0 to 0)
8.3
(0.2 to 38.5)
5.Secondary Outcome
Title Incidence of Adverse Events Graded as 3, 4, or 5 Per NCI CTCAE Version 4.0
Hide Description Fisher’s exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and graphically assessed differences in maximum grades observed for toxicities between the arms.
Time Frame Up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Adverse events graded as 3, 4 or 5 per NCI CTCAE version 4 (regardless of attribution)
Arm/Group Title Arm I (Tivantinib) Arm II (Placebo) Crossover From Placebo to Tivantinib
Hide Arm/Group Description:
Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.
Overall Number of Participants Analyzed 52 26 12
Measure Type: Number
Unit of Measure: patients
Acute coronary syndrome 1 0 0
Alkaline phosphatase increased 0 0 2
Anemia 3 0 2
Back pain 1 1 1
Confusion 0 2 0
Cataract 1 0 0
Death NOS 1 0 1
Dehydration 0 2 1
Dizziness 0 1 0
Duodenal ulcer 1 0 0
Dyspnea 0 1 0
Enterocolitis infectious 0 1 0
Fall 0 1 0
Fatigue 2 0 0
Febrile neutropenia 1 0 0
Gait disturbance 0 1 0
Generalized muscle weakness 0 1 0
Hypertension 1 0 0
Hypokalemia 0 1 0
Hyponatremia 1 0 0
Hypotension 0 1 0
Hypoxia 1 1 0
Infections and infestations - Other, specify 1 0 0
Lymph gland infection 1 0 0
Lymphocyte count decreased 2 2 2
Musculoskeletal and connective tissue disorder - O 0 1 0
Neoplasms benign, malignant and unspecified (incl 1 1 0
Nervous system disorders - Other, specify 0 1 0
Neutrophil count decreased 2 0 2
Platelet count decreased 1 0 0
Pleural effusion 0 0 1
Productive cough 0 0 1
Sinus bradycardia 3 0 0
Sinus tachycardia 0 1 0
Syncope 0 2 0
Thromboembolic event 0 1 0
Tumor pain 1 0 0
Upper respiratory infection 0 1 0
Urinary tract obstruction 0 0 1
White blood cell decreased 2 0 2
6.Other Pre-specified Outcome
Title Radiographic Response Rate Based on RECIST Criteria
Hide Description Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.
Time Frame Up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Tivantinib) Arm II (Placebo) Crossover From Placebo to Tivantinib
Hide Arm/Group Description:
Arm I: Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.
Overall Number of Participants Analyzed 52 26 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
1.9
(0.05 to 10.26)
0
(0 to 0)
8.3
(0.2 to 38.5)
7.Other Pre-specified Outcome
Title Change in Bone Specific Alkaline Phosphatase (BSAP) in Serum
Hide Description BSAP will first be descriptively summarized by treatment group and also evaluated using graphical analyses to assess potential patterns over time and see if changes in bone resorption differ between those who are progression-free at 12 weeks vs. not after treatment with tivantinib. The potential impact of early changes in these markers on PFS using Cox regression models will be also explored.
Time Frame Baseline to up to 6 months
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Change in Markers of Bone Turnover in Urine
Hide Description NTx and CTX will first be descriptively summarized by treatment group and also evaluated using graphical analyses to assess potential patterns over time and see if changes in bone resorption differ between those who are progression-free at 12 weeks vs. not after treatment with tivantinib. The potential impact of early changes in these markers on PFS using Cox regression models will be also explored.
Time Frame Baseline to up to 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
 
Arm/Group Title Arm I (Tivantinib) Arm II (Placebo) Crossover From Placebo to Tivantinib
Hide Arm/Group Description Patients receive tivantinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.
All-Cause Mortality
Arm I (Tivantinib) Arm II (Placebo) Crossover From Placebo to Tivantinib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/52 (13.46%)      4/26 (15.38%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Tivantinib) Arm II (Placebo) Crossover From Placebo to Tivantinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/52 (36.54%)      22/26 (84.62%)      5/12 (41.67%)    
Blood and lymphatic system disorders       
Anemia  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Cardiac disorders       
Acute coronary syndrome  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Sinus bradycardia  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Sinus tachycardia  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Constipation  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Diarrhea  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Duodenal ulcer  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Nausea  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
General disorders       
Death NOS  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Edema limbs  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Fatigue  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Fever  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Gait disturbance  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Infections and infestations       
Enterocolitis infectious  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Infections and infestations - Other, specify  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Upper respiratory infection  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Dehydration  1  0/52 (0.00%)  0 2/26 (7.69%)  2 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Generalized muscle weakness  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Tumor pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Nervous system disorders       
Dizziness  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Nervous system disorders - Other, specify  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Seizure  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Stroke  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Syncope  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Psychiatric disorders       
Confusion  1  0/52 (0.00%)  0 2/26 (7.69%)  2 0/12 (0.00%)  0
Renal and urinary disorders       
Urinary tract obstruction  1  0/52 (0.00%)  0 0/26 (0.00%)  0 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Hypoxia  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Pleural effusion  1  0/52 (0.00%)  0 0/26 (0.00%)  0 1/12 (8.33%)  1
Vascular disorders       
Hypotension  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Thromboembolic event  1  1/52 (1.92%)  1 2/26 (7.69%)  2 0/12 (0.00%)  0
1
Term from vocabulary, CTCAE version 400
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Tivantinib) Arm II (Placebo) Crossover From Placebo to Tivantinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/52 (100.00%)      26/26 (100.00%)      12/12 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  23/52 (44.23%)  23 12/26 (46.15%)  12 6/12 (50.00%)  6
Febrile neutropenia  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Lymph node pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Cardiac disorders       
Atrial fibrillation  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Cardiac disorders - Other, specify  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Sinus bradycardia  1  11/52 (21.15%)  11 1/26 (3.85%)  1 1/12 (8.33%)  1
Sinus tachycardia  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Ear and labyrinth disorders       
Ear pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Endocrine disorders       
Hypothyroidism  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Eye disorders       
Blurred vision  1  2/52 (3.85%)  2 3/26 (11.54%)  3 1/12 (8.33%)  1
Cataract  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Eye disorders - Other, specify  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Eye pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Flashing lights  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  1/52 (1.92%)  1 3/26 (11.54%)  3 1/12 (8.33%)  1
Bloating  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Colonic hemorrhage  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Constipation  1  14/52 (26.92%)  14 7/26 (26.92%)  7 3/12 (25.00%)  3
Diarrhea  1  8/52 (15.38%)  8 4/26 (15.38%)  4 3/12 (25.00%)  3
Dry mouth  1  2/52 (3.85%)  2 4/26 (15.38%)  4 0/12 (0.00%)  0
Dyspepsia  1  2/52 (3.85%)  2 2/26 (7.69%)  2 1/12 (8.33%)  1
Dysphagia  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Fecal incontinence  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Flatulence  1  2/52 (3.85%)  2 2/26 (7.69%)  2 0/12 (0.00%)  0
Gastric hemorrhage  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Gastroesophageal reflux disease  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Hemorrhoidal hemorrhage  1  2/52 (3.85%)  2 0/26 (0.00%)  0 0/12 (0.00%)  0
Hemorrhoids  1  4/52 (7.69%)  4 1/26 (3.85%)  1 0/12 (0.00%)  0
Mucositis oral  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Nausea  1  9/52 (17.31%)  9 5/26 (19.23%)  5 3/12 (25.00%)  3
Oral dysesthesia  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Oral pain  1  2/52 (3.85%)  2 2/26 (7.69%)  2 1/12 (8.33%)  1
Rectal hemorrhage  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Rectal pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Stomach pain  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Toothache  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Vomiting  1  4/52 (7.69%)  4 2/26 (7.69%)  2 1/12 (8.33%)  1
General disorders       
Chills  1  0/52 (0.00%)  0 1/26 (3.85%)  1 2/12 (16.67%)  2
Edema face  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Edema limbs  1  5/52 (9.62%)  5 2/26 (7.69%)  2 1/12 (8.33%)  1
Edema trunk  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Facial pain  1  2/52 (3.85%)  2 0/26 (0.00%)  0 0/12 (0.00%)  0
Fatigue  1  30/52 (57.69%)  30 11/26 (42.31%)  11 7/12 (58.33%)  7
Fever  1  1/52 (1.92%)  1 1/26 (3.85%)  1 1/12 (8.33%)  1
Flu like symptoms  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
General disorders and administration site conditions - Other, specify  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Irritability  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Localized edema  1  2/52 (3.85%)  2 2/26 (7.69%)  2 0/12 (0.00%)  0
Malaise  1  2/52 (3.85%)  2 0/26 (0.00%)  0 0/12 (0.00%)  0
Neck edema  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Non-cardiac chest pain  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Pain  1  5/52 (9.62%)  5 7/26 (26.92%)  7 2/12 (16.67%)  2
Infections and infestations       
Conjunctivitis infective  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Infections and infestations - Other, specify  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Lung infection  1  0/52 (0.00%)  0 0/26 (0.00%)  0 1/12 (8.33%)  1
Lymph gland infection  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Papulopustular rash  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Rhinitis infective  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Sinusitis  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Upper respiratory infection  1  3/52 (5.77%)  3 2/26 (7.69%)  2 0/12 (0.00%)  0
Urinary tract infection  1  2/52 (3.85%)  2 1/26 (3.85%)  1 1/12 (8.33%)  1
Injury, poisoning and procedural complications       
Bruising  1  0/52 (0.00%)  0 1/26 (3.85%)  1 1/12 (8.33%)  1
Burn  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Fracture  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Investigations       
Alanine aminotransferase increased  1  7/52 (13.46%)  7 2/26 (7.69%)  2 0/12 (0.00%)  0
Alkaline phosphatase increased  1  8/52 (15.38%)  8 5/26 (19.23%)  5 3/12 (25.00%)  3
Aspartate aminotransferase increased  1  13/52 (25.00%)  13 3/26 (11.54%)  3 2/12 (16.67%)  2
Creatinine increased  1  7/52 (13.46%)  7 1/26 (3.85%)  1 1/12 (8.33%)  1
Lymphocyte count decreased  1  11/52 (21.15%)  11 6/26 (23.08%)  6 4/12 (33.33%)  4
Lymphocyte count increased  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Neutrophil count decreased  1  5/52 (9.62%)  5 0/26 (0.00%)  0 5/12 (41.67%)  5
Platelet count decreased  1  3/52 (5.77%)  3 2/26 (7.69%)  2 1/12 (8.33%)  1
Weight gain  1  2/52 (3.85%)  2 0/26 (0.00%)  0 0/12 (0.00%)  0
Weight loss  1  4/52 (7.69%)  4 1/26 (3.85%)  1 0/12 (0.00%)  0
White blood cell decreased  1  12/52 (23.08%)  12 1/26 (3.85%)  1 5/12 (41.67%)  5
Metabolism and nutrition disorders       
Anorexia  1  17/52 (32.69%)  17 5/26 (19.23%)  5 6/12 (50.00%)  6
Dehydration  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Hypercalcemia  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Hyperglycemia  1  9/52 (17.31%)  9 3/26 (11.54%)  3 1/12 (8.33%)  1
Hyperkalemia  1  5/52 (9.62%)  5 0/26 (0.00%)  0 0/12 (0.00%)  0
Hypoalbuminemia  1  4/52 (7.69%)  4 2/26 (7.69%)  2 1/12 (8.33%)  1
Hypocalcemia  1  4/52 (7.69%)  4 1/26 (3.85%)  1 3/12 (25.00%)  3
Hypokalemia  1  3/52 (5.77%)  3 2/26 (7.69%)  2 3/12 (25.00%)  3
Hyponatremia  1  11/52 (21.15%)  11 3/26 (11.54%)  3 3/12 (25.00%)  3
Metabolism and nutrition disorders - Other, specify  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Back pain  1  9/52 (17.31%)  9 13/26 (50.00%)  13 3/12 (25.00%)  3
Bone pain  1  3/52 (5.77%)  3 1/26 (3.85%)  1 1/12 (8.33%)  1
Chest wall pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Flank pain  1  3/52 (5.77%)  3 2/26 (7.69%)  2 1/12 (8.33%)  1
Generalized muscle weakness  1  3/52 (5.77%)  3 3/26 (11.54%)  3 1/12 (8.33%)  1
Muscle weakness lower limb  1  3/52 (5.77%)  3 3/26 (11.54%)  3 1/12 (8.33%)  1
Muscle weakness upper limb  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  0/52 (0.00%)  0 0/26 (0.00%)  0 1/12 (8.33%)  1
Myalgia  1  2/52 (3.85%)  2 1/26 (3.85%)  1 0/12 (0.00%)  0
Pain in extremity  1  13/52 (25.00%)  13 11/26 (42.31%)  11 2/12 (16.67%)  2
Trismus  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Nervous system disorders       
Dizziness  1  5/52 (9.62%)  5 1/26 (3.85%)  1 1/12 (8.33%)  1
Dysgeusia  1  5/52 (9.62%)  5 2/26 (7.69%)  2 1/12 (8.33%)  1
Headache  1  1/52 (1.92%)  1 2/26 (7.69%)  2 2/12 (16.67%)  2
Ischemia cerebrovascular  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Memory impairment  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Paresthesia  1  0/52 (0.00%)  0 2/26 (7.69%)  2 0/12 (0.00%)  0
Peripheral motor neuropathy  1  2/52 (3.85%)  2 1/26 (3.85%)  1 0/12 (0.00%)  0
Peripheral sensory neuropathy  1  2/52 (3.85%)  2 4/26 (15.38%)  4 1/12 (8.33%)  1
Sinus pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Syncope  1  0/52 (0.00%)  0 1/26 (3.85%)  1 0/12 (0.00%)  0
Tremor  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Psychiatric disorders       
Anxiety  1  4/52 (7.69%)  4 2/26 (7.69%)  2 0/12 (0.00%)  0
Depression  1  1/52 (1.92%)  1 3/26 (11.54%)  3 0/12 (0.00%)  0
Insomnia  1  2/52 (3.85%)  2 1/26 (3.85%)  1 1/12 (8.33%)  1
Renal and urinary disorders       
Hematuria  1  4/52 (7.69%)  4 0/26 (0.00%)  0 0/12 (0.00%)  0
Proteinuria  1  2/52 (3.85%)  2 0/26 (0.00%)  0 0/12 (0.00%)  0
Renal and urinary disorders - Other, specify  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Urinary frequency  1  3/52 (5.77%)  3 4/26 (15.38%)  4 0/12 (0.00%)  0
Urinary incontinence  1  3/52 (5.77%)  3 0/26 (0.00%)  0 1/12 (8.33%)  1
Urinary retention  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Urinary tract pain  1  1/52 (1.92%)  1 1/26 (3.85%)  1 2/12 (16.67%)  2
Urinary urgency  1  2/52 (3.85%)  2 0/26 (0.00%)  0 1/12 (8.33%)  1
Reproductive system and breast disorders       
Breast pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Erectile dysfunction  1  0/52 (0.00%)  0 0/26 (0.00%)  0 1/12 (8.33%)  1
Genital edema  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Pelvic pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Penile pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Scrotal pain  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Cough  1  9/52 (17.31%)  9 2/26 (7.69%)  2 1/12 (8.33%)  1
Dyspnea  1  8/52 (15.38%)  8 0/26 (0.00%)  0 2/12 (16.67%)  2
Epistaxis  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Hoarseness  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Laryngeal mucositis  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Nasal congestion  1  2/52 (3.85%)  2 2/26 (7.69%)  2 1/12 (8.33%)  1
Postnasal drip  1  2/52 (3.85%)  2 0/26 (0.00%)  0 0/12 (0.00%)  0
Productive cough  1  0/52 (0.00%)  0 1/26 (3.85%)  1 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Sinus disorder  1  1/52 (1.92%)  1 0/26 (0.00%)  0 1/12 (8.33%)  1
Sore throat  1  3/52 (5.77%)  3 0/26 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  7/52 (13.46%)  7 2/26 (7.69%)  2 3/12 (25.00%)  3
Dry skin  1  2/52 (3.85%)  2 1/26 (3.85%)  1 0/12 (0.00%)  0
Erythema multiforme  1  2/52 (3.85%)  2 0/26 (0.00%)  0 0/12 (0.00%)  0
Hypertrichosis  1  0/52 (0.00%)  0 0/26 (0.00%)  0 1/12 (8.33%)  1
Nail ridging  1  2/52 (3.85%)  2 0/26 (0.00%)  0 0/12 (0.00%)  0
Periorbital edema  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Pruritus  1  3/52 (5.77%)  3 3/26 (11.54%)  3 0/12 (0.00%)  0
Rash acneiform  1  2/52 (3.85%)  2 1/26 (3.85%)  1 0/12 (0.00%)  0
Rash maculo-papular  1  5/52 (9.62%)  5 2/26 (7.69%)  2 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1  1/52 (1.92%)  1 1/26 (3.85%)  1 0/12 (0.00%)  0
Skin ulceration  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Urticaria  1  0/52 (0.00%)  0 2/26 (7.69%)  2 0/12 (0.00%)  0
Vascular disorders       
Hot flashes  1  5/52 (9.62%)  5 2/26 (7.69%)  2 0/12 (0.00%)  0
Hypertension  1  5/52 (9.62%)  5 2/26 (7.69%)  2 0/12 (0.00%)  0
Hypotension  1  1/52 (1.92%)  1 0/26 (0.00%)  0 2/12 (16.67%)  2
Lymphedema  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
Thromboembolic event  1  1/52 (1.92%)  1 0/26 (0.00%)  0 0/12 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Paul Monk, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: (614) 293-6196
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01519414     History of Changes
Other Study ID Numbers: NCI-2012-00237
NCI-2012-00237 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000721410
OSU11132
OSU-11132
OSU 11132 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
8986 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM00100 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
U01CA062491 ( U.S. NIH Grant/Contract )
First Submitted: January 25, 2012
First Posted: January 27, 2012
Results First Submitted: October 11, 2017
Results First Posted: September 12, 2018
Last Update Posted: September 12, 2018