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Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00521144
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : July 22, 2014
Last Update Posted : May 5, 2015
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 Recurrent Small Cell Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: obatoclax mesylate
Drug: topotecan hydrochloride
Other: laboratory biomarker analysis
Enrollment 22
Recruitment Details Protocol Open to Accrual 8/7/2007 Primary Completion Date 8/10/2010 Recruitment Location at medical clinic
Pre-assignment Details  
Arm/Group Title Phase I; Level 1: Obatoclax Mesylate + Topetecan Phase I; Level 2: Obatoclax Mesylate + Topetecan Phase I; Level 3: Obatoclax Mesylate + Topetecan Phase I; Level 4: Obatoclax Mesylate + Topotecan Phase II Obatoclax Mesylate + Topotecan in SCLC
Hide Arm/Group Description Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
Period Title: Overall Study
Started 6 5 3 1 7
Completed 2 2 1 0 0
Not Completed 4 3 2 1 7
Reason Not Completed
Not Treated             0             0             0             1             0
Adverse Event             0             1             0             0             1
Progressive Disease             4             2             2             0             6
Arm/Group Title Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 1 Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 2 Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 3 Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 4 Phase II Obatoclax Mesylate + Topotecan in SCLC Total
Hide Arm/Group Description Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2 Total of all reporting groups
Overall Number of Baseline Participants 6 5 3 1 7 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 3 participants 1 participants 7 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
3
  60.0%
2
  66.7%
0
   0.0%
4
  57.1%
14
  63.6%
>=65 years
1
  16.7%
2
  40.0%
1
  33.3%
1
 100.0%
3
  42.9%
8
  36.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 3 participants 1 participants 7 participants 22 participants
Female
5
  83.3%
1
  20.0%
1
  33.3%
1
 100.0%
6
  85.7%
14
  63.6%
Male
1
  16.7%
4
  80.0%
2
  66.7%
0
   0.0%
1
  14.3%
8
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 3 participants 1 participants 7 participants 22 participants
6 5 3 1 7 22
1.Primary Outcome
Title Overall Response Rate (Phase II)
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 Every 6 weeks, assessed up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
Arm/Group Title Phase I; Level 1: Obatoclax Mesylate + Topetecan Phase I; Level 2: Obatoclax Mesylate + Topetecan Phase I; Level 3: Obatoclax Mesylate + Topetecan Phase 1; Level 4: Obatoclax Mesylate + Topotecan Phase II Obatoclax Mesylate + Topotecan in SCLC
Hide Arm/Group Description:
Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
Overall Number of Participants Analyzed 6 5 3 0 7
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I; Level 1: Obatoclax Mesylate + Topotecan Phase I; Level 2: Obatoclax Mesylate + Topotecan Phase I; Level 3: Obatoclax Mesylate + Topotecan Phase I; Level 4: Obatoclax Mesylate + Topotecan Phase II Obatoclax Mesylate + Topotecan in SCLC
Hide Arm/Group Description Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
All-Cause Mortality
Phase I; Level 1: Obatoclax Mesylate + Topotecan Phase I; Level 2: Obatoclax Mesylate + Topotecan Phase I; Level 3: Obatoclax Mesylate + Topotecan Phase I; Level 4: Obatoclax Mesylate + Topotecan Phase II Obatoclax Mesylate + Topotecan in SCLC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I; Level 1: Obatoclax Mesylate + Topotecan Phase I; Level 2: Obatoclax Mesylate + Topotecan Phase I; Level 3: Obatoclax Mesylate + Topotecan Phase I; Level 4: Obatoclax Mesylate + Topotecan Phase II Obatoclax Mesylate + Topotecan in SCLC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/6 (66.67%)      4/5 (80.00%)      2/3 (66.67%)      0/1 (0.00%)      4/7 (57.14%)    
Blood and lymphatic system disorders           
Anemia-Hemoglobin decrease  1  0/6 (0.00%)  0 2/5 (40.00%)  2 1/3 (33.33%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0
Cardiac disorders           
Atrial Fibrillation  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Atrial flutter  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Gastrointestinal disorders           
Abdominal pain  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  2
General disorders           
Fatigue  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Fever  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
Immune system disorders           
Allergic Reaction-Hypersensitivity  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Infections and infestations           
Urinary Tract Infection  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Infection, other  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Investigations           
ALT, SGPT  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 1/7 (14.29%)  1
Alkaline phosphatase  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 1/7 (14.29%)  2
AST, SGOT  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 2/7 (28.57%)  3
Blood bilirubin increase  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders           
Hyponatremia  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Hypomagnesemia (low magnesium)  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0 0/7 (0.00%)  0
Hypokalemia  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0 0/7 (0.00%)  0
Dehydration  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders           
Back pain  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders           
Ataxia (incoordination)  1  2/6 (33.33%)  2 2/5 (40.00%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Depressed level of consciousness  1  1/6 (16.67%)  2 3/5 (60.00%)  3 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Dysgeusia  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Dizziness  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Psychiatric disorders           
Euphoria  1  3/6 (50.00%)  4 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Depression  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Renal and urinary disorders           
Cystitis  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders           
Hypoxia  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Voice Alteration  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Death-NOS  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE V 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I; Level 1: Obatoclax Mesylate + Topotecan Phase I; Level 2: Obatoclax Mesylate + Topotecan Phase I; Level 3: Obatoclax Mesylate + Topotecan Phase I; Level 4: Obatoclax Mesylate + Topotecan Phase II Obatoclax Mesylate + Topotecan in SCLC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      3/5 (60.00%)      2/3 (66.67%)      0/1 (0.00%)      7/7 (100.00%)    
Gastrointestinal disorders           
Constipation  1  2/6 (33.33%)  3 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  3
Diarrhea  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
Mucositis-oral  1  1/6 (16.67%)  2 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
Nausea  1  4/6 (66.67%)  6 2/5 (40.00%)  4 1/3 (33.33%)  1 0/1 (0.00%)  0 3/7 (42.86%)  6
Vomiting  1  2/6 (33.33%)  2 2/5 (40.00%)  3 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  3
Heartburn/dyspepsia  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
General disorders           
Fatigue  1  4/6 (66.67%)  6 2/5 (40.00%)  4 2/3 (66.67%)  3 0/1 (0.00%)  0 5/7 (71.43%)  7
Infections and infestations           
Mucosal Infection  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Investigations           
White blood cell count decrease  1  3/6 (50.00%)  3 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 6/7 (85.71%)  14
Neutrophil count decrease  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  7
Platelet count decrease  1  1/6 (16.67%)  1 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 6/7 (85.71%)  16
ALT, SGPT  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
AST, SGOT  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
Alkaline phosphatase  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 4/7 (57.14%)  8
Lymphocyte count decrease  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Metabolism and nutrition disorders           
Anorexia  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
Hyperglycemia  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  4
Anemia-Hemoglobin decrease  1  3/6 (50.00%)  6 2/5 (40.00%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0 4/7 (57.14%)  22
Albumin, low (hypoalbuminemia)  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  4
Musculoskeletal and connective tissue disorders           
Back Pain  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Bone pain  1  1/6 (16.67%)  1 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Chest wall pain  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Pain in extremity  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
Nervous system disorders           
Ataxia (incoordination)  1  5/6 (83.33%)  11 2/5 (40.00%)  6 2/3 (66.67%)  4 0/1 (0.00%)  0 7/7 (100.00%)  21
Depressed level of consciousness  1  4/6 (66.67%)  7 3/5 (60.00%)  6 1/3 (33.33%)  1 0/1 (0.00%)  0 7/7 (100.00%)  31
Dysgeusia (taste alteration)  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Dizziness  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Speech impairment  1  1/6 (16.67%)  1 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Neuropathy-sensory  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 3/7 (42.86%)  3
Pain-Head/Headache  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Extrapyramidal disorder  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Psychiatric disorders           
Depression  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
Euphoria  1  3/6 (50.00%)  3 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Psychosis  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Mood alteration-Agitation  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/7 (14.29%)  1
Renal and urinary disorders           
Glomerular filtration rate decrease  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
Respiratory, thoracic and mediastinal disorders           
Cough  1  0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 3/7 (42.86%)  3
Dyspnea  1  3/6 (50.00%)  3 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 4/7 (57.14%)  6
Hemorrhage, Nose  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0 3/7 (42.86%)  3
Sinusitis  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Hypoxia  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders           
Alopecia  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 2/7 (28.57%)  2
Erythema multiforme  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Rash/desquamation  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Name/Title: Dr. Lee Krug
Organization: Memorial Sloan-Kettering Cancer Center
Phone: 646 888 4201
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00521144     History of Changes
Obsolete Identifiers: NCT01645657
Other Study ID Numbers: NCI-2009-00252
07-082 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000561779 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: August 24, 2007
First Posted: August 27, 2007
Results First Submitted: October 11, 2013
Results First Posted: July 22, 2014
Last Update Posted: May 5, 2015