ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 16 for:    11784875 [PUBMED-IDS]

A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)

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: NCT01100931
Recruitment Status : Completed
First Posted : April 9, 2010
Results First Posted : April 4, 2013
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions NSCLC
Solid Tumors
Interventions Drug: YM155
Drug: Carboplatin
Drug: Paclitaxel
Enrollment 42

Recruitment Details  
Pre-assignment Details One patient withdrew consent before starting treatment.
Arm/Group Title Phase I Phase II
Hide Arm/Group Description Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days). Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
Period Title: Phase I
Started 22 0
Completed 22 0
Not Completed 0 0
Period Title: Phase II
Started 0 19
Completed 0 19
Not Completed 0 0
Arm/Group Title Phase I Phase II Total
Hide Arm/Group Description Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days). Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days. Total of all reporting groups
Overall Number of Baseline Participants 22 19 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  63.6%
13
  68.4%
27
  65.9%
>=65 years
8
  36.4%
6
  31.6%
14
  34.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 19 participants 41 participants
62.3  (10.72) 59.8  (9.51) 61.6  (10.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
Female
12
  54.5%
8
  42.1%
20
  48.8%
Male
10
  45.5%
11
  57.9%
21
  51.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
Hispanic or Latino
3
  13.6%
2
  10.5%
5
  12.2%
Not Hispanic or Latino
19
  86.4%
17
  89.5%
36
  87.8%
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 22 participants 19 participants 41 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
  27.3%
0
   0.0%
6
  14.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   5.3%
1
   2.4%
Black or African American
3
  13.6%
3
  15.8%
6
  14.6%
White
13
  59.1%
14
  73.7%
27
  65.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   5.3%
1
   2.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 19 participants 41 participants
22 19 41
1.Primary Outcome
Title Phase 1 Safe and Tolerable Phase 2 Dose.
Hide Description

Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).

Phase 2 dose is based upon dose limiting toxicities experienced during cycle 1.

Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Phase I dose was variable dosing schedule to determine maximum tolerated dose (MTD) with 22 patients analyzed. Dose was variable with MTD at 10mg/m^2.
Arm/Group Title Phase I
Hide Arm/Group Description:
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: mg/m^2
10
2.Primary Outcome
Title Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).
Hide Description Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame up to 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Phase I is not included here because this outcome measure is for phase II only.
Arm/Group Title Phase II
Hide Arm/Group Description:
Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
Complete Response 0
Partial Response 2
3.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Time Frame 31.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I Phase II
Hide Arm/Group Description:
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
Overall Number of Participants Analyzed 22 19
Measure Type: Number
Unit of Measure: Participants
22 19
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I Phase II
Hide Arm/Group Description Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days). Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
All-Cause Mortality
Phase I Phase II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I Phase II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/22 (45.45%)      1/19 (5.26%)    
Blood and lymphatic system disorders     
Febrile Neutropenia  1  2/22 (9.09%)  2 0/19 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Enterocolitis infectious  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Pancreatitis  1  1/22 (4.55%)  1 0/19 (0.00%)  0
General disorders     
Death NOS  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Fever  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Flu like symptoms  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations     
Sepsis  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Sinusitis  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Mucosal infection  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Investigations     
Neutrophil count decreased  1  4/22 (18.18%)  4 0/19 (0.00%)  0
Platelet count decreased  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Metabolism and nutrition disorders     
Hyponatremia  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Nervous system disorders     
Seizure  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Stroke  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Syncope  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Respiratory failure  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Upper respiratory infection  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Pleural effusion  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Vascular disorders     
Hypotension  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Thromboembolic event  1  1/22 (4.55%)  1 0/19 (0.00%)  0
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%
Phase I Phase II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/22 (100.00%)      19/19 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  16/22 (72.73%)  61 7/19 (36.84%)  14
Cardiac disorders     
Atrial fibrillation  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Chest pain - cardiac  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Sinus tachycardia  1  3/22 (13.64%)  3 2/19 (10.53%)  3
Ventricular arrhythmia  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Ear and labyrinth disorders     
Hearing impaired  1  2/22 (9.09%)  2 0/19 (0.00%)  0
Otitis media  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Vertigo  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Eye disorders     
Blurred vision  1  1/22 (4.55%)  1 4/19 (21.05%)  4
Conjunctivitis  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Eye infection  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders     
Abdominal pain  1  4/22 (18.18%)  5 0/19 (0.00%)  0
Bloating  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Constipation  1  9/22 (40.91%)  9 9/19 (47.37%)  9
Diarrhea  1  2/22 (9.09%)  2 2/19 (10.53%)  2
Dry mouth  1  1/22 (4.55%)  1 1/19 (5.26%)  1
Dyspepsia  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Dysphagia  1  4/22 (18.18%)  5 0/19 (0.00%)  0
Esophageal pain  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Esophagitis  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Flatulence  1  3/22 (13.64%)  3 0/19 (0.00%)  0
Gastroesophageal reflux disease  1  1/22 (4.55%)  1 1/19 (5.26%)  1
Mucositis Oral  1  1/22 (4.55%)  2 6/19 (31.58%)  7
Nausea  1  8/22 (36.36%)  8 9/19 (47.37%)  10
Oral hemorrhage  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Oral pain  1  2/22 (9.09%)  2 0/19 (0.00%)  0
Rectal pain  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Stomach pain  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Vomiting  1  4/22 (18.18%)  4 7/19 (36.84%)  8
General disorders     
Chills  1  1/22 (4.55%)  2 0/19 (0.00%)  0
Edema face  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Edema limbs  1  3/22 (13.64%)  5 2/19 (10.53%)  2
Fatigue  1  10/22 (45.45%)  13 11/19 (57.89%)  12
Fever  1  3/22 (13.64%)  3 0/19 (0.00%)  0
Flu like symptoms  1  2/22 (9.09%)  4 4/19 (21.05%)  4
Malaise  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Non-cardiac chest pain  1  1/22 (4.55%)  1 2/19 (10.53%)  2
Pain  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Immune system disorders     
Allergic reaction  1  0/22 (0.00%)  0 3/19 (15.79%)  3
Infections and infestations     
Bronchial infection  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Lung infection  1  4/22 (18.18%)  5 0/19 (0.00%)  0
Mucosal infection  1  3/22 (13.64%)  3 0/19 (0.00%)  0
Skin infection  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Urethral infection  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Urinary tract infection  1  1/22 (4.55%)  2 2/19 (10.53%)  2
Injury, poisoning and procedural complications     
Fall  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Vascular access complication  1  1/22 (4.55%)  1 1/19 (5.26%)  2
Investigations     
Activated partial thromboplastin time prolonged  1  7/22 (31.82%)  11 0/19 (0.00%)  0
Alanine aminotransferase increased  1  6/22 (27.27%)  20 0/19 (0.00%)  0
Alkaline phosphatase increased  1  5/22 (22.73%)  12 1/19 (5.26%)  1
Aspartate aminotransferase increased  1  6/22 (27.27%)  15 0/19 (0.00%)  0
Blood bilirubin increased  1  3/22 (13.64%)  4 0/19 (0.00%)  0
Creatinine increased  1  7/22 (31.82%)  11 0/19 (0.00%)  0
Electrocardiogram QT corrected interval prolong  1  3/22 (13.64%)  3 0/19 (0.00%)  0
Lipase increased  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Lymphocyte count decreased  1  20/22 (90.91%)  108 14/19 (73.68%)  47
lymphocyte count increased  1  2/22 (9.09%)  2 0/19 (0.00%)  0
Neutrophil count decreased  1  20/22 (90.91%)  49 13/19 (68.42%)  29
Platelet count decreased  1  12/22 (54.55%)  37 3/19 (15.79%)  4
Weight gain  1  2/22 (9.09%)  3 1/19 (5.26%)  1
Weight loss  1  3/22 (13.64%)  3 0/19 (0.00%)  0
White blood cell decreased  1  20/22 (90.91%)  74 12/19 (63.16%)  29
Metabolism and nutrition disorders     
Anorexia  1  9/22 (40.91%)  9 3/19 (15.79%)  3
Dehydration  1  2/22 (9.09%)  3 1/19 (5.26%)  1
Glucose intolerance  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Hypercalcemia  1  3/22 (13.64%)  3 0/19 (0.00%)  0
Hyperglycemia  1  1/22 (4.55%)  1 1/19 (5.26%)  3
Hyperkalemia  1  4/22 (18.18%)  8 2/19 (10.53%)  2
Hypermagnesemia  1  6/22 (27.27%)  8 0/19 (0.00%)  0
Hypernatremia  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Hyperuricemia  1  0/22 (0.00%)  0 1/19 (5.26%)  2
Hypoalbuminemia  1  7/22 (31.82%)  17 4/19 (21.05%)  5
Hypocalcemia  1  1/22 (4.55%)  2 1/19 (5.26%)  4
Hypokalemia  1  6/22 (27.27%)  18 2/19 (10.53%)  5
Hypomagnesemia  1  16/22 (72.73%)  56 11/19 (57.89%)  14
Hyponatremia  1  12/22 (54.55%)  31 2/19 (10.53%)  2
Hypophosphatemia  1  14/22 (63.64%)  33 3/19 (15.79%)  7
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/22 (13.64%)  3 6/19 (31.58%)  6
Back pain  1  1/22 (4.55%)  1 2/19 (10.53%)  2
Bone pain  1  3/22 (13.64%)  3 2/19 (10.53%)  2
Buttock pain  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Chest wall pain  1  1/22 (4.55%)  1 1/19 (5.26%)  1
Generalized muscle weakness  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Muscle weakness lower limb  1  2/22 (9.09%)  3 1/19 (5.26%)  1
Muscle weakness upper limb  1  1/22 (4.55%)  2 0/19 (0.00%)  0
Myalgia  1  5/22 (22.73%)  5 4/19 (21.05%)  4
Neck pain  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Pain in extremity  1  0/22 (0.00%)  0 2/19 (10.53%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Nervous system disorders     
Cognitive disturbance  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Dizziness  1  2/22 (9.09%)  4 4/19 (21.05%)  4
Dysgeusia  1  2/22 (9.09%)  3 2/19 (10.53%)  2
Headache  1  3/22 (13.64%)  3 7/19 (36.84%)  7
Memory impairment  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Paresthesia  1  4/22 (18.18%)  4 0/19 (0.00%)  0
Peripheral motor neuropathy  1  0/22 (0.00%)  0 3/19 (15.79%)  3
Peripheral sensory neuropathy  1  12/22 (54.55%)  16 17/19 (89.47%)  23
Presyncope  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Tremor  1  1/22 (4.55%)  1 1/19 (5.26%)  1
Psychiatric disorders     
Agitation  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Anxiety  1  2/22 (9.09%)  3 2/19 (10.53%)  2
Delirium  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Depression  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Insomnia  1  6/22 (27.27%)  6 5/19 (26.32%)  5
Restlessness  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Urinary frequency  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Reproductive system and breast disorders     
Irregular menstruation  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Testicular pain  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary hemorrhage  1  2/22 (9.09%)  3 0/19 (0.00%)  0
Cough  1  5/22 (22.73%)  5 2/19 (10.53%)  2
Dyspnea  1  3/22 (13.64%)  4 6/19 (31.58%)  6
Epistaxis  1  1/22 (4.55%)  1 1/19 (5.26%)  1
Hiccups  1  1/22 (4.55%)  1 2/19 (10.53%)  2
Hoarseness  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Hypoxia  1  1/22 (4.55%)  1 1/19 (5.26%)  1
Laryngeal inflammation  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Nasal congestion  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Pleural effusion  1  1/22 (4.55%)  1 1/19 (5.26%)  1
Pneumonitis  1  1/22 (4.55%)  3 0/19 (0.00%)  0
Sore throat  1  2/22 (9.09%)  3 1/19 (5.26%)  1
Upper respiratory infection  1  1/22 (4.55%)  1 3/19 (15.79%)  3
Voice alteration  1  1/22 (4.55%)  1 1/19 (5.26%)  1
Wheezing  1  0/22 (0.00%)  0 2/19 (10.53%)  3
Skin and subcutaneous tissue disorders     
Alopecia  1  14/22 (63.64%)  14 16/19 (84.21%)  16
Dry skin  1  1/22 (4.55%)  1 2/19 (10.53%)  2
hyperhidrosis  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Nail discoloration  1  2/22 (9.09%)  2 0/19 (0.00%)  0
Papulopustular rash  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Photosensitivity  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Pruritus  1  4/22 (18.18%)  4 1/19 (5.26%)  1
Rash acneiform  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Rash maculo-papular  1  4/22 (18.18%)  7 0/19 (0.00%)  0
Scalp pain  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Skin ulceration  1  2/22 (9.09%)  2 0/19 (0.00%)  0
Vascular disorders     
Flushing  1  2/22 (9.09%)  2 3/19 (15.79%)  3
Hot flashes  1  0/22 (0.00%)  0 1/19 (5.26%)  1
Hypertension  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Hypotension  1  4/22 (18.18%)  4 1/19 (5.26%)  2
Phlebitis  1  2/22 (9.09%)  2 0/19 (0.00%)  0
Superior vena cava syndrome  1  1/22 (4.55%)  1 0/19 (0.00%)  0
Thromboembolic event  1  1/22 (4.55%)  1 3/19 (15.79%)  3
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 NOT 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. Giuseppe Giaccone
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-4916
Responsible Party: Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01100931     History of Changes
Other Study ID Numbers: 100051
10-C-0051
First Submitted: April 8, 2010
First Posted: April 9, 2010
Results First Submitted: February 21, 2013
Results First Posted: April 4, 2013
Last Update Posted: October 19, 2015