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Trial record 45 of 228 for:    metformin and cancer AND Hypoglycemic

Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

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: NCT01433913
Recruitment Status : Completed
First Posted : September 14, 2011
Results First Posted : May 15, 2015
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Interventions Drug: metformin hydrochloride
Other: placebo
Other: laboratory biomarker analysis
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks. Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Period Title: Overall Study
Started 10 10
Completed 9 10
Not Completed 1 0
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo) Total
Hide Arm/Group Description Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg metformin tablets until the day before surgery) for 4-12 weeks. Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets until the day before surgery) for 4-12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  40.0%
6
  60.0%
10
  50.0%
>=65 years
6
  60.0%
4
  40.0%
10
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
65  (10) 61  (6) 63  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
10
 100.0%
20
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC)
Hide Description Data between the two study groups will be compared using a two-group t-test at a two-sided 0.05 level of significance. If the data are not normally distributed, a non-parametric rank-sum test will be utilized.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with tissue sections available from prostatectomy
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg metformin tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 9
Median (Inter-Quartile Range)
Unit of Measure: % positively stained nuclei
6.5
(3.33 to 9.33)
3.67
(2 to 6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Prostate Tissue Metformin Concentration Levels as Assessed by Liquid Chromatography Tandem Mass Spectrometry
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
analysis limited to patients with fresh frozen prostatectomy tissue
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 7
Median (Inter-Quartile Range)
Unit of Measure: ug/g tissue
5.71
(2.62 to 16.18)
0
(0 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Apoptosis Levels in the Prostatectomy Tissue as Assessed by IHC of Cleaved Caspase 3
Hide Description Average number of positively stained cells that exhibited nuclear fragmentation from five randomly selected high-power fields (40x) in the tumor region was calculated for each participant
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with tissue sections available from prostatectomy
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 9
Median (Inter-Quartile Range)
Unit of Measure: Number of positive cells
0.07
(0.0 to 0.27)
0.1
(0.0 to 0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Cyclin D1
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with tissue sections available from prostatectomy
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 9
Median (Inter-Quartile Range)
Unit of Measure: % positive cells
37.5
(20.83 to 59.17)
13.3
(6.7 to 21.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title mTOR Regulation in the Prostatectomy Tissue as Assessed by IHC of Phospho-p70 S6 Kinase (p-p70S6K)
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with tissue sections available from prostatectomy
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 9
Median (Inter-Quartile Range)
Unit of Measure: % positive cells
66.7
(36.67 to 88.33)
63.3
(39.2 to 80.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Angiogenesis in the Prostatectomy Tissue as Assessed by IHC of CD34
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected due to budgetary constraints
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title AMPK Activation in the Prostatectomy Tissue as Assessed by IHC of p-AMPK
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected due to budgetary constraints
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Retinoblastoma Protein Phosphorylation (p-pRb)
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected due to budgetary constraints
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Changes in Serum PSA
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis limited to participants with fasting serum samples
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 10
Median (Inter-Quartile Range)
Unit of Measure: % change
-6.53
(-9.45 to 16.76)
5.98
(-6.91 to 22.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Changes in Serum Fasting Insulin
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
analysis limited to participants with fasting serum samples
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 10
Median (Inter-Quartile Range)
Unit of Measure: % change
-11.42
(-33.26 to 16.88)
5.66
(-10.67 to 22.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Changes in Serum IGF-1/IGFBP-3
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
analysis limited to participants with fasting serum samples
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 10
Median (Inter-Quartile Range)
Unit of Measure: % change
7.07
(-8.51 to 21.77)
-2.24
(-18.2 to 25.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Changes in Serum Testosterone
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
analysis limited to participants with fasting serum samples
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 10
Median (Inter-Quartile Range)
Unit of Measure: % change
-16.12
(-20.43 to 3.10)
2.04
(-16.70 to 28.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Changes in Serum SHBG
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
analysis limited to participants with fasting serum samples
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 8 10
Median (Inter-Quartile Range)
Unit of Measure: % change
0.48
(-6.64 to 7.19)
-6.49
(-12.43 to 4.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Metformin Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Changes in Serum Fasting Glucose
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected because insulin is a more relevant outcome measure than glucose
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Metformin Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description

Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.

metformin hydrochloride: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO QD for 4-12 weeks.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Arm I (Metformin Hydrochloride) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Metformin Hydrochloride) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   0/10 (0.00%) 
Infections and infestations     
influenza  1/10 (10.00%)  0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Metformin Hydrochloride) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   6/10 (60.00%)   5/10 (50.00%) 
Cardiac disorders     
Chest pain  0/10 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders     
Constipation  1/10 (10.00%)  0/10 (0.00%) 
Diarrhea  2/10 (20.00%)  0/10 (0.00%) 
Bloating  0/10 (0.00%)  1/10 (10.00%) 
Nausea  1/10 (10.00%)  1/10 (10.00%) 
Diverticulosis  1/10 (10.00%)  0/10 (0.00%) 
General disorders     
Pain  1/10 (10.00%)  0/10 (0.00%) 
Infections and infestations     
Upper respiratory infection  1/10 (10.00%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1/10 (10.00%)  0/10 (0.00%) 
Backpain  0/10 (0.00%)  1/10 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Sessile polyps in colon and rectum  1/10 (10.00%)  0/10 (0.00%) 
Nervous system disorders     
Headache  1/10 (10.00%)  1/10 (10.00%) 
Paresthesia  0/10 (0.00%)  1/10 (10.00%) 
Psychiatric disorders     
Insomnia  0/10 (0.00%)  1/10 (10.00%) 
Renal and urinary disorders     
Urinary retention  1/10 (10.00%)  1/10 (10.00%) 
Urinary urgency  1/10 (10.00%)  0/10 (0.00%) 
Increased urinating frequency  0/10 (0.00%)  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
Chest congestion  0/10 (0.00%)  1/10 (10.00%) 
Cough  0/10 (0.00%)  1/10 (10.00%) 
Nasal congestion  0/10 (0.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1/10 (10.00%)  0/10 (0.00%) 
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: Dr. Sherry Chow
Organization: University of Arizona
Phone: 520-626-3358
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01433913     History of Changes
Obsolete Identifiers: NCT01528527
Other Study ID Numbers: NCI-2012-00243
NCI-2012-00243 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000712087
UARIZ-UAZ10-16-01
11-0211-04 ( Other Identifier: Arizona Cancer Center - Tucson )
UAZ10-16-01 ( Other Identifier: DCP )
N01CN35158 ( U.S. NIH Grant/Contract )
P30CA023074 ( U.S. NIH Grant/Contract )
First Submitted: September 9, 2011
First Posted: September 14, 2011
Results First Submitted: April 29, 2015
Results First Posted: May 15, 2015
Last Update Posted: January 10, 2018