Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 50 for:    MK-2206

Akt Inhibitor MK2206 or Everolimus in Treating Patients With Refractory Kidney 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: NCT01239342
Recruitment Status : Unknown
Verified May 2017 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2010
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Renal Cell Cancer
Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Interventions Drug: Akt Inhibitor MK2206
Drug: Everolimus
Other: Laboratory Biomarker Analysis
Enrollment 43
Recruitment Details Recruitment Period: January 27, 2011 to January 9, 2013. All recruitment done in medical clinic settings.
Pre-assignment Details  
Arm/Group Title MK2206 Everolimus
Hide Arm/Group Description Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks. Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
Period Title: Overall Study
Started 29 14
Completed 26 8
Not Completed 3 6
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             1             5
Reason Unknown             1             1
Arm/Group Title MK2206 Everolimus Total
Hide Arm/Group Description Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks. Everolimus 10 mg orally once daily, courses repeat every 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 29 14 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants 14 participants 43 participants
59
(43 to 83)
63.5
(48 to 84)
62
(43 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 14 participants 43 participants
Female
8
  27.6%
0
   0.0%
8
  18.6%
Male
21
  72.4%
14
 100.0%
35
  81.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 14 participants 43 participants
Hispanic or Latino
1
   3.4%
5
  35.7%
6
  14.0%
Not Hispanic or Latino
28
  96.6%
9
  64.3%
37
  86.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 14 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.4%
0
   0.0%
1
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   6.9%
0
   0.0%
2
   4.7%
White
26
  89.7%
14
 100.0%
40
  93.0%
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:  Participants
United States Number Analyzed 29 participants 14 participants 43 participants
29 14 43
1.Primary Outcome
Title Median Progression Free Survival (PFS) in Months
Hide Description PFS defined as Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first. Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions.
Time Frame Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in each group left study before restaging therefore are excluded from response outcome analysis.
Arm/Group Title MK2206 Everolimus
Hide Arm/Group Description:
Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
Overall Number of Participants Analyzed 28 13
Median (95% Confidence Interval)
Unit of Measure: Months
3.68
(1.77 to 5.75)
5.98 [1] 
(5.03 to NA)
[1]
Trial met futility criteria at the planned interim analysis therefore full confidence interval was not estimable.
2.Secondary Outcome
Title Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)
Hide Description Clinical benefit defined as participants' with CR+PR+SD assessed using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase >5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in each group left study before restaging therefore are excluded from outcome analysis.
Arm/Group Title MK2206 Everolimus
Hide Arm/Group Description:
Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
Overall Number of Participants Analyzed 28 13
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
1
   3.6%
0
   0.0%
Partial Response
3
  10.7%
0
   0.0%
Stable Disease
11
  39.3%
11
  84.6%
Progressive Disease
13
  46.4%
2
  15.4%
3.Secondary Outcome
Title Summary of Selected Toxicities Grade 3 or Greater Toxicity Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hide Description Adverse Events (AEs) list of reported events with associated intervention agent in a uniform presentation of events. The method of Thall, Simon and Estey (1995, 1996) was used to collect study participants’ safety data summarized by treatment arm, category, severity and relevance. Comprehensive listing of AEs collected on study can be found in Adverse Event section separated by severity, Serious and Other AEs and represented by treatment arm, organ system-category within defined severity.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MK2206 Everolimus
Hide Arm/Group Description:
Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
Overall Number of Participants Analyzed 29 14
Measure Type: Number
Unit of Measure: Toxicities
Hyperglycemia 7 1
Hypertriglyceridemia 1 1
Hyperuricemia 2 0
Lymphocyte count decreased 2 1
Mucositis oral 1 0
Rash maculo-papular 8 0
Pruritus 1 0
Proteinuria 1 0
Pancreatitis 1 0
Lipase increased 1 0
Generalized muscle weakness 1 0
Dyspnea 1 0
Dehydration 2 0
4.Secondary Outcome
Title Overall Response Rate (ORR) Defined as Complete Response (CR) + Partial Response (PR)
Hide Description Response for CR + PR defined by RECIST version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase >5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in each group left study before restaging therefore are excluded from response outcome analysis.
Arm/Group Title MK2206 Everolimus
Hide Arm/Group Description:
Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
Overall Number of Participants Analyzed 28 13
Measure Type: Number
Unit of Measure: percentage of participants
14.3 0
5.Secondary Outcome
Title Median Overall Survival (OS) in Months
Hide Description Overall survival reported in months as time interval between the date of treatment and the date of death or last follow-up.
Time Frame Time interval between the date of treatment and the date of death or last follow-up, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MK2206 Everolimus
Hide Arm/Group Description:
Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
Overall Number of Participants Analyzed 29 14
Median (Full Range)
Unit of Measure: Months
23.5
(10.7 to 37.4)
15.7 [1] 
(6.5 to NA)
[1]
"NA" as this value is not estimable due to the small sample size which generated a very wide confidence interval.
6.Secondary Outcome
Title Time to Failure (TTF)
Hide Description TTF defined as Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date.
Time Frame Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants analyzed. Data not collected.
Arm/Group Title MK2206 Everolimus
Hide Arm/Group Description:
Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events collected through each 28 day course, and reporting for events that occur within 30 Days of the last dose of the investigational agent.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK2206 Everolimus
Hide Arm/Group Description Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks. Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
All-Cause Mortality
MK2206 Everolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MK2206 Everolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   7/29 (24.14%)   2/14 (14.29%) 
Gastrointestinal disorders     
Abdominal Pain  1  1/29 (3.45%)  0/14 (0.00%) 
Pancreatitis  1  1/29 (3.45%)  0/14 (0.00%) 
General disorders     
Death NOS  1  4/29 (13.79%)  1/14 (7.14%) 
Infections and infestations     
Appendicitis  1  0/29 (0.00%)  1/14 (7.14%) 
Metabolism and nutrition disorders     
Hypercalcemia  1  2/29 (6.90%)  0/14 (0.00%) 
Dehydration  1  1/29 (3.45%)  0/14 (0.00%) 
Hyperuricemia  1  1/29 (3.45%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal bone pain  1  1/29 (3.45%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  1/29 (3.45%)  0/14 (0.00%) 
Pleural Effusion  1  0/29 (0.00%)  1/14 (7.14%) 
Dyspnea  1  0/29 (0.00%)  1/14 (7.14%) 
Vascular disorders     
Thromboembolic event  1  1/29 (3.45%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MK2206 Everolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   29/29 (100.00%)   13/14 (92.86%) 
Blood and lymphatic system disorders     
Anemia  1  24/29 (82.76%)  11/14 (78.57%) 
Disseminated intravascular coagulation  1  1/29 (3.45%)  0/14 (0.00%) 
Cardiac disorders     
Cardiac disorders - (Other), specify  1  2/29 (6.90%)  1/14 (7.14%) 
Chest pain - cardiac  1  1/29 (3.45%)  0/14 (0.00%) 
Palpitations  1  1/29 (3.45%)  0/14 (0.00%) 
Sinus tachycardia  1  1/29 (3.45%)  0/14 (0.00%) 
Ear and labyrinth disorders     
Ear pain  1  2/29 (6.90%)  0/14 (0.00%) 
Hearing impaired  1  1/29 (3.45%)  0/14 (0.00%) 
Endocrine disorders     
Endocrine disorders - (Other), specify  1  11/29 (37.93%)  6/14 (42.86%) 
Hyperthyroidism  1  8/29 (27.59%)  2/14 (14.29%) 
Hypothyroidism  1  2/29 (6.90%)  1/14 (7.14%) 
Eye disorders     
Dry eye  1  1/29 (3.45%)  0/14 (0.00%) 
Eye disorders - (Other), specify  1  2/29 (6.90%)  0/14 (0.00%) 
Watering eyes  1  6/29 (20.69%)  3/14 (21.43%) 
Gastrointestinal disorders     
Abdominal distension  1  0/29 (0.00%)  1/14 (7.14%) 
Abdominal pain  1  8/29 (27.59%)  3/14 (21.43%) 
Ascites  1  1/29 (3.45%)  1/14 (7.14%) 
Bloating  1  0/29 (0.00%)  1/14 (7.14%) 
Constipation  1  5/29 (17.24%)  4/14 (28.57%) 
Diarrhea  1  11/29 (37.93%)  7/14 (50.00%) 
Dry mouth  1  1/29 (3.45%)  0/14 (0.00%) 
Dysesthesia  1  2/29 (6.90%)  1/14 (7.14%) 
Dysphagia  1  1/29 (3.45%)  1/14 (7.14%) 
Gastritis  1  0/29 (0.00%)  1/14 (7.14%) 
Gastroesophageal reflux disease  1  1/29 (3.45%)  0/14 (0.00%) 
Gastrointestinal disorders - (Other), specify  1  1/29 (3.45%)  0/14 (0.00%) 
Gastrointestinal pain  1  0/29 (0.00%)  2/14 (14.29%) 
Mucositis oral  1  13/29 (44.83%)  7/14 (50.00%) 
Nausea  1  14/29 (48.28%)  5/14 (35.71%) 
Vomiting  1  9/29 (31.03%)  2/14 (14.29%) 
General disorders     
Chills  1  0/29 (0.00%)  1/14 (7.14%) 
Edema face  1  1/29 (3.45%)  0/14 (0.00%) 
Edema limbs  1  10/29 (34.48%)  7/14 (50.00%) 
Fatigue  1  24/29 (82.76%)  12/14 (85.71%) 
Fever  1  4/29 (13.79%)  2/14 (14.29%) 
Flatulence  1  1/29 (3.45%)  0/14 (0.00%) 
Localized edema  1  1/29 (3.45%)  0/14 (0.00%) 
Non-cardiac chest pain  1  2/29 (6.90%)  2/14 (14.29%) 
Pain  1  10/29 (34.48%)  2/14 (14.29%) 
Weight loss  1  4/29 (13.79%)  1/14 (7.14%) 
Immune system disorders     
Allergic reaction  1  2/29 (6.90%)  0/14 (0.00%) 
Infections and infestations     
Abdominal infection  1  0/29 (0.00%)  1/14 (7.14%) 
Infections and infestations - (Other), specify  1  3/29 (10.34%)  5/14 (35.71%) 
Lung infection  1  2/29 (6.90%)  0/14 (0.00%) 
Papulopustular rash  1  0/29 (0.00%)  1/14 (7.14%) 
Sinusitis  1  2/29 (6.90%)  1/14 (7.14%) 
Upper respiratory infection  1  3/29 (10.34%)  0/14 (0.00%) 
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications - (Other)  1  0/29 (0.00%)  1/14 (7.14%) 
Investigations     
Activated partial thromboplastin time prolonged  1  18/29 (62.07%)  3/14 (21.43%) 
Alanine aminotransferase increased  1  4/29 (13.79%)  1/14 (7.14%) 
Alkaline phosphatase increased  1  11/29 (37.93%)  7/14 (50.00%) 
Aspartate aminotransferase increased  1  5/29 (17.24%)  4/14 (28.57%) 
Cholesterol high  1  17/29 (58.62%)  12/14 (85.71%) 
Creatinine increased  1  25/29 (86.21%)  10/14 (71.43%) 
INR increased  1  1/29 (3.45%)  0/14 (0.00%) 
Investigations - (Other)  1  0/29 (0.00%)  1/14 (7.14%) 
Lipase increased  1  1/29 (3.45%)  0/14 (0.00%) 
Lymphocyte count decreased  1  20/29 (68.97%)  10/14 (71.43%) 
Neutrophil count decreased  1  1/29 (3.45%)  2/14 (14.29%) 
Platelet count decreased  1  3/29 (10.34%)  5/14 (35.71%) 
Serum amylase increased  1  1/29 (3.45%)  0/14 (0.00%) 
White blood cell decreased  1  6/29 (20.69%)  4/14 (28.57%) 
Metabolism and nutrition disorders     
Anorexia  1  5/29 (17.24%)  3/14 (21.43%) 
Dehydration  1  4/29 (13.79%)  0/14 (0.00%) 
Glucose intolerance  1  3/29 (10.34%)  1/14 (7.14%) 
Hypercalcemia  1  5/29 (17.24%)  2/14 (14.29%) 
Hyperglycemia  1  28/29 (96.55%)  10/14 (71.43%) 
Hyperkalemia  1  10/29 (34.48%)  4/14 (28.57%) 
Hypermagnesemia  1  1/29 (3.45%)  0/14 (0.00%) 
Hypernatremia  1  1/29 (3.45%)  0/14 (0.00%) 
Hypertriglyceridemia  1  20/29 (68.97%)  12/14 (85.71%) 
Hyperuricemia  1  14/29 (48.28%)  3/14 (21.43%) 
Hypoalbuminemia  1  7/29 (24.14%)  3/14 (21.43%) 
Hypocalcemia  1  4/29 (13.79%)  3/14 (21.43%) 
Hypoglycemia  1  3/29 (10.34%)  0/14 (0.00%) 
Hypokalemia  1  3/29 (10.34%)  2/14 (14.29%) 
Hypomagnesemia  1  9/29 (31.03%)  1/14 (7.14%) 
Hyponatremia  1  10/29 (34.48%)  2/14 (14.29%) 
Hypophosphatemia  1  5/29 (17.24%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/29 (6.90%)  2/14 (14.29%) 
Back pain  1  12/29 (41.38%)  5/14 (35.71%) 
Bone pain  1  2/29 (6.90%)  1/14 (7.14%) 
Chest wall pain  1  3/29 (10.34%)  3/14 (21.43%) 
Flank pain  1  1/29 (3.45%)  0/14 (0.00%) 
Gait disturbance  1  2/29 (6.90%)  0/14 (0.00%) 
Generalized muscle weakness  1  1/29 (3.45%)  0/14 (0.00%) 
Muscle weakness trunk  1  1/29 (3.45%)  0/14 (0.00%) 
Muscle weakness upper limb  1  0/29 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorder - Specify (Other)  1  2/29 (6.90%)  0/14 (0.00%) 
Neck pain  1  0/29 (0.00%)  1/14 (7.14%) 
Pain in extremity  1  3/29 (10.34%)  0/14 (0.00%) 
Nervous system disorders     
Ataxia  1  0/29 (0.00%)  1/14 (7.14%) 
Dizziness  1  2/29 (6.90%)  0/14 (0.00%) 
Dysgeusia  1  2/29 (6.90%)  2/14 (14.29%) 
Headache  1  3/29 (10.34%)  3/14 (21.43%) 
Nervous system disorders - (Other), specify  1  0/29 (0.00%)  1/14 (7.14%) 
Neuralgia  1  1/29 (3.45%)  0/14 (0.00%) 
Paresthesia  1  1/29 (3.45%)  1/14 (7.14%) 
Peripheral sensory neuropathy  1  1/29 (3.45%)  1/14 (7.14%) 
Psychiatric disorders     
Anxiety  1  2/29 (6.90%)  1/14 (7.14%) 
Confusion  1  1/29 (3.45%)  0/14 (0.00%) 
Depression  1  4/29 (13.79%)  1/14 (7.14%) 
Insomnia  1  2/29 (6.90%)  1/14 (7.14%) 
Renal and urinary disorders     
Hemoglobinuria  1  1/29 (3.45%)  0/14 (0.00%) 
Proteinuria  1  15/29 (51.72%)  12/14 (85.71%) 
Urinary frequency  1  2/29 (6.90%)  0/14 (0.00%) 
Urinary tract infection  1  1/29 (3.45%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/29 (3.45%)  4/14 (28.57%) 
Atelectasis  1  0/29 (0.00%)  1/14 (7.14%) 
Bronchial infection  1  1/29 (3.45%)  0/14 (0.00%) 
Cough  1  3/29 (10.34%)  6/14 (42.86%) 
Dyspnea  1  13/29 (44.83%)  9/14 (64.29%) 
Epistaxis  1  0/29 (0.00%)  1/14 (7.14%) 
Hiccups  1  1/29 (3.45%)  0/14 (0.00%) 
Hoarseness  1  1/29 (3.45%)  2/14 (14.29%) 
Laryngeal inflammation  1  1/29 (3.45%)  1/14 (7.14%) 
Nasal congestion  1  1/29 (3.45%)  0/14 (0.00%) 
Pleural effusion  1  2/29 (6.90%)  3/14 (21.43%) 
Pneumonitis  1  3/29 (10.34%)  4/14 (28.57%) 
Productive cough  1  1/29 (3.45%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders - (Other), specify  1  1/29 (3.45%)  1/14 (7.14%) 
Sleep apnea  1  1/29 (3.45%)  0/14 (0.00%) 
Wheezing  1  1/29 (3.45%)  1/14 (7.14%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  3/29 (10.34%)  4/14 (28.57%) 
Dry skin  1  5/29 (17.24%)  1/14 (7.14%) 
Nail loss  1  1/29 (3.45%)  0/14 (0.00%) 
Palmar-plantar erythrodysesthesia syndrome  1  5/29 (17.24%)  1/14 (7.14%) 
Pruritus  1  9/29 (31.03%)  2/14 (14.29%) 
Rash acneiform  1  1/29 (3.45%)  6/14 (42.86%) 
Rash maculo-papular  1  24/29 (82.76%)  6/14 (42.86%) 
Rash pustular  1  1/29 (3.45%)  0/14 (0.00%) 
Scalp pain  1  0/29 (0.00%)  1/14 (7.14%) 
Surgical and medical procedures     
Surgical and medical procedures - (Other), specify  1  2/29 (6.90%)  2/14 (14.29%) 
Vascular disorders     
Hypertension  1  3/29 (10.34%)  1/14 (7.14%) 
Hypotension  1  1/29 (3.45%)  0/14 (0.00%) 
Thromboembolic event  1  1/29 (3.45%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
Layout table for Results Point of Contact information
Name/Title: Eric Jonasch, MD/Professor, Genitourinary Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01239342     History of Changes
Other Study ID Numbers: NCI-2010-02270
NCI-2010-02270 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI 8727
MDA-2010-0247
CDR0000688457
2010-0247 ( Other Identifier: MD Anderson Cancer Center )
8727 ( Other Identifier: CTEP )
N01CM00038 ( U.S. NIH Grant/Contract )
N01CM00039 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: November 10, 2010
First Posted: November 11, 2010
Results First Submitted: March 22, 2017
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017