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Trial record 53 of 115 for:    medullary carcinoma

Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by 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: NCT00381641
Recruitment Status : Active, not recruiting
First Posted : September 28, 2006
Results First Posted : September 15, 2017
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Differentiated Thyroid Gland Carcinoma
Recurrent Thyroid Gland Carcinoma
Refractory Thyroid Gland Carcinoma
Stage III Thyroid Gland Follicular Carcinoma AJCC v7
Stage III Thyroid Gland Medullary Carcinoma AJCC v7
Stage IV Thyroid Gland Follicular Carcinoma AJCC v7
Stage IV Thyroid Gland Medullary Carcinoma AJCC v7
Stage IV Thyroid Gland Papillary Carcinoma AJCC v7
Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7
Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7
Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7
Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7
Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7
Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7
Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7
Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7
Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7
Thyroid Gland Hurthle Cell Carcinoma
Unresectable Thyroid Gland Carcinoma
Interventions Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Drug: Sunitinib
Drug: Sunitinib Malate
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup
Hide Arm/Group Description

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Period Title: Overall Study
Started 38 25
Completed 38 23
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup Total
Hide Arm/Group Description

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Total of all reporting groups
Overall Number of Baseline Participants 38 25 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 38 participants 25 participants 63 participants
59.1
(37 to 76)
50.9
(23 to 73)
55.8
(23 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 25 participants 63 participants
Female
14
  36.8%
12
  48.0%
26
  41.3%
Male
24
  63.2%
13
  52.0%
37
  58.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 25 participants 63 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
4
  16.0%
4
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.6%
1
   4.0%
2
   3.2%
White
37
  97.4%
20
  80.0%
57
  90.5%
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:  Participants
United States Number Analyzed 38 participants 25 participants 63 participants
38 25 63
1.Primary Outcome
Title Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or 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 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup
Hide Arm/Group Description:

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Overall Number of Participants Analyzed 38 25
Measure Type: Count of Participants
Unit of Measure: Participants
9
  23.7%
7
  28.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib Malate-Radioactive Iodine Refractory Subgroup, Sunitinib Malate-Metastatic Medullary Subgroup
Comments Note. The objective was not to compare the two arms (subgroups), but to compare each with historical data.
Type of Statistical Test Superiority
Comments

Null (historical) response rate for iodine refractory subgroup is 10%. Power=90% for 30% alternative.

Null (historical) response rate for metastatic medullary subgroup is 5%. Power=88% for 25% alternative.

Statistical Test of Hypothesis P-Value <0.10
Comments

For iodine refractory subgroup, null hypothesis could be rejected if 6 or more responses were observed.

For metastatic medullary subgroup, null hypothesis could be rejected if 3 or more responses were observed.

Method Simon, two-stage design
Comments [Not Specified]
2.Secondary Outcome
Title Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0
Hide Description Any grade toxicity of any type, regardless of attribution
Time Frame From time of first treatment with sunitinib, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup
Hide Arm/Group Description:

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Overall Number of Participants Analyzed 38 25
Measure Type: Count of Participants
Unit of Measure: Participants
38
 100.0%
24
  96.0%
3.Secondary Outcome
Title Overall Survival
Hide Description Kaplan-Meier curves will be generated and 95% confidence intervals will be derived for median overall survival.
Time Frame Up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup
Hide Arm/Group Description:

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Overall Number of Participants Analyzed 38 25
Median (95% Confidence Interval)
Unit of Measure: Months
32.6
(18.4 to 70.9)
65.4
(27.0 to 69.5)
4.Secondary Outcome
Title Time to Progression or Death Evaluated Using the RECIST
Hide Description [Not Specified]
Time Frame Time from start of treatment to time of progression or death of any cause, assessed up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup
Hide Arm/Group Description:

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Overall Number of Participants Analyzed 38 25
Median (95% Confidence Interval)
Unit of Measure: Months
12.8
(8.3 to 16.4)
19.3
(7.7 to 34.6)
5.Other Pre-specified Outcome
Title Changes in Laboratory Correlates Analyzed Using Paired T-tests
Hide Description Relevant laboratory correlates will be compared between responders and non-responders using the Wilcoxon rank sum test. The association between the presence or absence of RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorphisms in the RET gene and response, will be analyzed using Fisher’s exact test. The correlative and genetic data will also be entered as covariates (univariate analyses only due to the small sample size) in a Cox regression model of progression-free survival.
Time Frame Baseline to 2 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup
Hide Arm/Group Description

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup

Sunitinib Malate: Given PO

All-Cause Mortality
Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup
Affected / at Risk (%) Affected / at Risk (%)
Total   21/38 (55.26%)   5/25 (20.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup
Affected / at Risk (%) Affected / at Risk (%)
Total   17/38 (44.74%)   12/25 (48.00%) 
Cardiac disorders     
Cardiac disorders - Other *  1/38 (2.63%)  0/25 (0.00%) 
Left ventricular systolic dysfunction *  2/38 (5.26%)  0/25 (0.00%) 
Pericardial effusion *  0/38 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders     
Abdominal pain *  0/38 (0.00%)  2/25 (8.00%) 
Dysphagia *  1/38 (2.63%)  1/25 (4.00%) 
Gastric hemorrhage *  1/38 (2.63%)  0/25 (0.00%) 
Gastric ulcer *  1/38 (2.63%)  0/25 (0.00%) 
Gastritis *  1/38 (2.63%)  0/25 (0.00%) 
Gastrointestinal disorders - Other *  0/38 (0.00%)  1/25 (4.00%) 
Mucositis oral *  0/38 (0.00%)  1/25 (4.00%) 
Oral pain *  0/38 (0.00%)  1/25 (4.00%) 
Small intestinal obstruction *  0/38 (0.00%)  1/25 (4.00%) 
General disorders     
Death NOS *  1/38 (2.63%)  0/25 (0.00%) 
Fatigue *  1/38 (2.63%)  0/25 (0.00%) 
Hepatobiliary disorders     
Cholecystitis *  0/38 (0.00%)  1/25 (4.00%) 
Hepatic failure *  2/38 (5.26%)  0/25 (0.00%) 
Infections and infestations     
Infections and infestations - Other *  0/38 (0.00%)  1/25 (4.00%) 
Skin infection *  1/38 (2.63%)  0/25 (0.00%) 
Urinary tract infection *  1/38 (2.63%)  0/25 (0.00%) 
Investigations     
Neutrophil count decreased *  1/38 (2.63%)  0/25 (0.00%) 
Platelet count decreased *  1/38 (2.63%)  0/25 (0.00%) 
Metabolism and nutrition disorders     
Anorexia *  0/38 (0.00%)  2/25 (8.00%) 
Dehydration *  2/38 (5.26%)  1/25 (4.00%) 
Hyponatremia *  1/38 (2.63%)  0/25 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain *  0/38 (0.00%)  1/25 (4.00%) 
Buttock pain *  0/38 (0.00%)  1/25 (4.00%) 
Nervous system disorders     
Peripheral motor neuropathy *  0/38 (0.00%)  1/25 (4.00%) 
Renal and urinary disorders     
Acute kidney injury *  1/38 (2.63%)  0/25 (0.00%) 
Reproductive system and breast disorders     
Reproductive system and breast disorders - Other *  0/38 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchial obstruction *  0/38 (0.00%)  1/25 (4.00%) 
Dyspnea *  0/38 (0.00%)  2/25 (8.00%) 
Epistaxis *  1/38 (2.63%)  1/25 (4.00%) 
Laryngeal edema *  1/38 (2.63%)  0/25 (0.00%) 
Laryngeal obstruction *  0/38 (0.00%)  1/25 (4.00%) 
Pleural effusion *  1/38 (2.63%)  0/25 (0.00%) 
Pneumonitis *  2/38 (5.26%)  2/25 (8.00%) 
Pneumothorax *  0/38 (0.00%)  1/25 (4.00%) 
Tracheal fistula *  1/38 (2.63%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulceration *  0/38 (0.00%)  1/25 (4.00%) 
Vascular disorders     
Hypertension *  1/38 (2.63%)  0/25 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib Malate-Radioactive Iodine Refractory Subgroup Sunitinib Malate-Metastatic Medullary Subgroup
Affected / at Risk (%) Affected / at Risk (%)
Total   38/38 (100.00%)   24/25 (96.00%) 
Blood and lymphatic system disorders     
Anemia *  29/38 (76.32%)  14/25 (56.00%) 
Endocrine disorders     
Hyperthyroidism *  0/38 (0.00%)  4/25 (16.00%) 
Hypothyroidism *  1/38 (2.63%)  4/25 (16.00%) 
Eye disorders     
Eye disorders - Other *  0/38 (0.00%)  2/25 (8.00%) 
Gastrointestinal disorders     
Abdominal pain *  4/38 (10.53%)  5/25 (20.00%) 
Constipation *  13/38 (34.21%)  4/25 (16.00%) 
Diarrhea *  25/38 (65.79%)  11/25 (44.00%) 
Dry mouth *  5/38 (13.16%)  2/25 (8.00%) 
Dyspepsia *  14/38 (36.84%)  1/25 (4.00%) 
Dysphagia *  2/38 (5.26%)  1/25 (4.00%) 
Flatulence *  2/38 (5.26%)  1/25 (4.00%) 
Gastritis *  3/38 (7.89%)  2/25 (8.00%) 
Gastrointestinal disorders - Other *  2/38 (5.26%)  2/25 (8.00%) 
Mucositis oral *  18/38 (47.37%)  12/25 (48.00%) 
Nausea *  20/38 (52.63%)  13/25 (52.00%) 
Oral pain *  5/38 (13.16%)  2/25 (8.00%) 
Rectal hemorrhage *  1/38 (2.63%)  2/25 (8.00%) 
Toothache *  2/38 (5.26%)  0/25 (0.00%) 
Vomiting *  14/38 (36.84%)  3/25 (12.00%) 
General disorders     
Edema face *  2/38 (5.26%)  8/25 (32.00%) 
Edema limbs *  4/38 (10.53%)  4/25 (16.00%) 
Fatigue *  33/38 (86.84%)  18/25 (72.00%) 
Fever *  6/38 (15.79%)  2/25 (8.00%) 
Non-cardiac chest pain *  3/38 (7.89%)  2/25 (8.00%) 
Pain *  3/38 (7.89%)  11/25 (44.00%) 
Infections and infestations     
Bronchial infection *  2/38 (5.26%)  0/25 (0.00%) 
Lung infection *  2/38 (5.26%)  1/25 (4.00%) 
Sinusitis *  4/38 (10.53%)  0/25 (0.00%) 
Skin infection *  2/38 (5.26%)  1/25 (4.00%) 
Upper respiratory infection *  3/38 (7.89%)  0/25 (0.00%) 
Urinary tract infection *  2/38 (5.26%)  0/25 (0.00%) 
Injury, poisoning and procedural complications     
Bruising *  0/38 (0.00%)  2/25 (8.00%) 
Investigations     
Alanine aminotransferase increased *  14/38 (36.84%)  6/25 (24.00%) 
Alkaline phosphatase increased *  8/38 (21.05%)  4/25 (16.00%) 
Aspartate aminotransferase increased *  16/38 (42.11%)  4/25 (16.00%) 
Blood bilirubin increased *  3/38 (7.89%)  4/25 (16.00%) 
Creatinine increased *  6/38 (15.79%)  1/25 (4.00%) 
Investigations - Other *  0/38 (0.00%)  6/25 (24.00%) 
Lipase increased *  0/38 (0.00%)  3/25 (12.00%) 
Lymphocyte count decreased *  20/38 (52.63%)  14/25 (56.00%) 
Neutrophil count decreased *  21/38 (55.26%)  8/25 (32.00%) 
Platelet count decreased *  22/38 (57.89%)  12/25 (48.00%) 
Serum amylase increased *  0/38 (0.00%)  3/25 (12.00%) 
Weight loss *  3/38 (7.89%)  3/25 (12.00%) 
White blood cell decreased *  30/38 (78.95%)  19/25 (76.00%) 
Metabolism and nutrition disorders     
Anorexia *  13/38 (34.21%)  9/25 (36.00%) 
Dehydration *  2/38 (5.26%)  1/25 (4.00%) 
Hyperglycemia *  27/38 (71.05%)  17/25 (68.00%) 
Hyperkalemia *  1/38 (2.63%)  3/25 (12.00%) 
Hypernatremia *  2/38 (5.26%)  2/25 (8.00%) 
Hypoalbuminemia *  10/38 (26.32%)  3/25 (12.00%) 
Hypocalcemia *  12/38 (31.58%)  10/25 (40.00%) 
Hypoglycemia *  4/38 (10.53%)  1/25 (4.00%) 
Hypokalemia *  7/38 (18.42%)  4/25 (16.00%) 
Hyponatremia *  4/38 (10.53%)  3/25 (12.00%) 
Hypophosphatemia *  6/38 (15.79%)  4/25 (16.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia *  4/38 (10.53%)  4/25 (16.00%) 
Back pain *  4/38 (10.53%)  6/25 (24.00%) 
Bone pain *  3/38 (7.89%)  0/25 (0.00%) 
Generalized muscle weakness *  1/38 (2.63%)  3/25 (12.00%) 
Myalgia *  2/38 (5.26%)  3/25 (12.00%) 
Neck pain *  3/38 (7.89%)  0/25 (0.00%) 
Pain in extremity *  9/38 (23.68%)  6/25 (24.00%) 
Nervous system disorders     
Dizziness *  5/38 (13.16%)  4/25 (16.00%) 
Dysgeusia *  10/38 (26.32%)  6/25 (24.00%) 
Headache *  9/38 (23.68%)  6/25 (24.00%) 
Peripheral sensory neuropathy *  7/38 (18.42%)  3/25 (12.00%) 
Psychiatric disorders     
Anxiety *  3/38 (7.89%)  0/25 (0.00%) 
Insomnia *  4/38 (10.53%)  1/25 (4.00%) 
Renal and urinary disorders     
Renal and urinary disorders - Other *  2/38 (5.26%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis *  4/38 (10.53%)  0/25 (0.00%) 
Bronchopulmonary hemorrhage *  2/38 (5.26%)  0/25 (0.00%) 
Cough *  10/38 (26.32%)  4/25 (16.00%) 
Dyspnea *  7/38 (18.42%)  3/25 (12.00%) 
Epistaxis *  8/38 (21.05%)  4/25 (16.00%) 
Pharyngolaryngeal pain *  5/38 (13.16%)  0/25 (0.00%) 
Sinus disorder *  2/38 (5.26%)  0/25 (0.00%) 
Voice alteration *  2/38 (5.26%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia *  3/38 (7.89%)  7/25 (28.00%) 
Dry skin *  5/38 (13.16%)  1/25 (4.00%) 
Hyperhidrosis *  2/38 (5.26%)  1/25 (4.00%) 
Nail loss *  1/38 (2.63%)  2/25 (8.00%) 
Palmar-plantar erythrodysesthesia syndrome *  18/38 (47.37%)  12/25 (48.00%) 
Rash maculo-papular *  8/38 (21.05%)  7/25 (28.00%) 
Skin and subcutaneous tissue disorders - Other *  1/38 (2.63%)  4/25 (16.00%) 
Vascular disorders     
Hot flashes *  3/38 (7.89%)  0/25 (0.00%) 
Hypertension *  18/38 (47.37%)  4/25 (16.00%) 
Hypotension *  2/38 (5.26%)  0/25 (0.00%) 
Vascular disorders - Other *  0/38 (0.00%)  2/25 (8.00%) 
*
Indicates events were collected by non-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
Layout table for Results Point of Contact information
Name/Title: Dr. Tanguy Seiwert
Organization: University of Chicago
Phone: (773) 702-2452
EMail: tseiwert@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00381641     History of Changes
Other Study ID Numbers: NCI-2009-00213
NCI-2009-00213 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UCCRC-14696A
CDR0000502260
NCI-7735
14696A
7735 ( Other Identifier: University of Chicago Comprehensive Cancer Center )
7735 ( Other Identifier: CTEP )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
P30CA014599 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: August 18, 2017
Results First Posted: September 15, 2017
Last Update Posted: October 22, 2019