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Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung 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: NCT01533181
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Recurrent Small Cell Lung Carcinoma
Interventions Other: Laboratory Biomarker Analysis
Drug: Linsitinib
Other: Pharmacological Study
Drug: Topotecan Hydrochloride
Enrollment 44
Recruitment Details Participants were enrolled at Moffitt Cancer Center and nine other institutions in the United States from July 3, 2012 through November 1, 2013.
Pre-assignment Details  
Arm/Group Title Arm A: Topotecan Arm B: OS-906
Hide Arm/Group Description Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease. OS-906 (linsitinib) daily, continuously, every 3 weeks.
Period Title: Overall Study
Started 15 29
Completed 14 28
Not Completed 1 1
Reason Not Completed
Disease progression pre-active treatment             0             1
Patient withdrawal pre-active treatment             1             0
Arm/Group Title Arm A: Topotecan Arm B: OS-906 Total
Hide Arm/Group Description Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease. OS-906 (linsitinib) daily, continuously, every 3 weeks. Total of all reporting groups
Overall Number of Baseline Participants 15 29 44
Hide Baseline Analysis Population Description
All participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 29 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  60.0%
17
  58.6%
26
  59.1%
>=65 years
6
  40.0%
12
  41.4%
18
  40.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 29 participants 44 participants
64
(34 to 86)
62
(37 to 79)
64
(34 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 29 participants 44 participants
Female
8
  53.3%
17
  58.6%
25
  56.8%
Male
7
  46.7%
12
  41.4%
19
  43.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 29 participants 44 participants
15 29 44
1.Primary Outcome
Title Median Progression Free Survival (PFS)
Hide Description PFS: Time from randomization to time of disease progression or death. PFS summarized with the Kaplan-Meier (K-M) method by two arms (experimental versus control). Confidence intervals for the median PFS and PFS rates at different time points to be constructed when appropriate.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title Arm A: Topotecan Arm B: OS-906
Hide Arm/Group Description:
Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
OS-906 (linsitinib) daily, continuously, every 3 weeks.
Overall Number of Participants Analyzed 14 28
Median (95% Confidence Interval)
Unit of Measure: months
3
(1.5 to 3.6)
1.2
(1.1 to 1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Topotecan, Arm B: OS-906
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Kaplan-Meier
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
1.9 to 8.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) + Progressive Disease (PD). DCR summarized using both point estimates and exact confidence intervals based on the binomial distribution by arm.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants at time of analysis
Arm/Group Title Arm A: Topotecan Arm B: OS-906
Hide Arm/Group Description:
Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
OS-906 (linsitinib) daily, continuously, every 3 weeks.
Overall Number of Participants Analyzed 12 25
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0
Partial Response 2 0
Stable Disease 4 1
Progressive Disease 6 24
Disease Control Rate 6 1
3.Secondary Outcome
Title Incidence of Serious Adverse Events (SAEs) Possibly/Probably Definitely Related to Study Drugs
Hide Description Participants with Grade 3 and 4 toxicities, possibly/probably/definitely related to study drugs. Number of Participants is per Event Category. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Time Frame 1 year, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title Arm A: Topotecan Arm B: OS-906
Hide Arm/Group Description:
Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
OS-906 (linsitinib) daily, continuously, every 3 weeks.
Overall Number of Participants Analyzed 14 28
Measure Type: Number
Unit of Measure: participants
Anemia 1 1
Blood and lymphatic system disorders - Other 2 0
Thrombotic thrombocytopenic purpura 1 0
Diarrhea 1 0
Esophagitis 1 0
Pancreatitis 1 0
Fatigue 1 3
Alanine aminotransferase increased 0 2
Investigations - Other 1 0
Lymphocyte count decreased 2 3
Neutrophil count decreased 4 0
Platelet count decreased 4 2
White blood cell decreased 4 0
Anorexia 0 1
Dehydration 2 0
Hyperglycemia 0 1
Hypokalemia 1 0
Hyponatremia 0 1
Headache 0 1
Hypoxia 0 1
Thromboembolic event 1 0
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS: Time from study enrollment to death from any cause. OS summarized similarly to PFS utilizing the K-M method.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title Arm A: Topotecan Arm B: OS-906
Hide Arm/Group Description:
Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
OS-906 (linsitinib) daily, continuously, every 3 weeks.
Overall Number of Participants Analyzed 14 28
Median (95% Confidence Interval)
Unit of Measure: months
5.3
(2.2 to 7.6)
3.4
(1.8 to 5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Topotecan, Arm B: OS-906
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Kaplan-Meier
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.6 to 2.2
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Changes in Biomarker Expression
Hide Description To be assessed by the Wilcoxon rank sum test.
Time Frame Baseline to up to day 1 of course 3
Outcome Measure Data Not Reported
Time Frame 1 year, 6 months
Adverse Event Reporting Description

Adverse Events are reported for all participants who received treatment, regardless of causality.

Grades 3, 4 and 5 are noted on the appropriate reported SAEs.

Note: Causality for SAEs is addressed in the Secondary Outcome Measure area.

 
Arm/Group Title Arm A: Topotocan Arm B: OS-906
Hide Arm/Group Description Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease. OS-906 (linsitinib) daily, continuously, every 3 weeks.
All-Cause Mortality
Arm A: Topotocan Arm B: OS-906
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: Topotocan Arm B: OS-906
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/14 (50.00%)      18/28 (64.29%)    
Blood and lymphatic system disorders     
Anemia  1 [1]  2/14 (14.29%)  2 0/28 (0.00%)  0
Blood and lymphatic system disorders - Other, Pancytopenia  1 [2]  1/14 (7.14%)  1 0/28 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Diarrhea  1 [3]  1/14 (7.14%)  1 0/28 (0.00%)  0
Esophagitis  1 [3]  1/14 (7.14%)  1 0/28 (0.00%)  0
Nausea  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Pancreatitis  1 [3]  1/14 (7.14%)  1 0/28 (0.00%)  0
Vomiting  1  1/14 (7.14%)  1 0/28 (0.00%)  0
General disorders     
Death NOS  1 [4]  7/14 (50.00%)  7 12/28 (42.86%)  12
Fever  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Non-cardiac chest pain  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Pain  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Infections and infestations     
Enterocolitis infectious  1 [3]  1/14 (7.14%)  1 0/28 (0.00%)  0
Infections and infestations - Other, Possible pneumonia per x-ray  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Lung infection  1 [5]  0/14 (0.00%)  0 3/28 (10.71%)  4
Urinary tract infection  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Injury, poisoning and procedural complications     
Fracture  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Investigations     
Alanine aminotransferase increased  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Aspartate aminotransferase increased  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Blood bilirubin increase  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Lymphocyte count decreased  1 [2]  0/14 (0.00%)  0 1/28 (3.57%)  1
Neutrophil count decreased  1 [2]  1/14 (7.14%)  1 0/28 (0.00%)  0
Platelet count decreased  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
White blood cell decreased  1 [2]  2/14 (14.29%)  2 0/28 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1 [6]  2/14 (14.29%)  2 2/28 (7.14%)  2
Hyperglycemia  1  0/14 (0.00%)  0 2/28 (7.14%)  2
Hypokalemia  1 [3]  1/14 (7.14%)  1 0/28 (0.00%)  0
Hyponatremia  1 [2]  1/14 (7.14%)  1 0/28 (0.00%)  0
Hyponatremia  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Musculoskeletal and connective tissue disorders     
Bone pain  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Muscle weakness left-sided  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other, Progressive disease  1 [2]  0/14 (0.00%)  0 3/28 (10.71%)  3
Neoplasms benign, malignant and unspecified - Other, Death  1 [4]  0/14 (0.00%)  0 6/28 (21.43%)  6
Tumor pain  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Nervous system disorders     
Headache  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Intracranial hemorrhage  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Lethargy  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Psychiatric disorders     
Confusion  1 [3]  1/14 (7.14%)  1 1/28 (3.57%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Dyspnea  1 [7]  0/14 (0.00%)  0 3/28 (10.71%)  6
Hypoxia  1 [3]  0/14 (0.00%)  0 2/28 (7.14%)  2
Respiratory failure  1 [8]  0/14 (0.00%)  0 1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders - Other, COPD  1 [3]  0/14 (0.00%)  0 1/28 (3.57%)  1
Vascular disorders     
Hypotension  1 [3]  1/14 (7.14%)  1 0/28 (0.00%)  0
Superior vena cava syndrome - Death  1 [4]  0/14 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
[1]
Arm A: 1 Grade 3 event
[2]
Grade 4
[3]
Grade 3
[4]
No Death SAE was due to treatment. All due to disease progression. Grade 5
[5]
3 Grade 3, 1 Grade 5
[6]
Arm A: Grade 3
[7]
5 events were Grade 3
[8]
Grade 5
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: Topotocan Arm B: OS-906
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/14 (85.71%)      28/28 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  11/14 (78.57%)  25 7/28 (25.00%)  12
Blood and lymphatic system disorders - Other  1  2/14 (14.29%)  2 2/28 (7.14%)  2
Thrombotic thrombocytopenic purpura  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Cardiac disorders     
Sinus tachycardia  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Atrial fibrillation  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Ear and labyrinth disorders     
Ear pain  1  0/14 (0.00%)  0 1/28 (3.57%)  2
Tinnitus  1  1/14 (7.14%)  2 0/28 (0.00%)  0
Eye disorders     
Eyelid function disorder  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Watering eyes  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Gastrointestinal disorders     
Nausea  1  6/14 (42.86%)  7 13/28 (46.43%)  15
Vomiting  1  6/14 (42.86%)  8 8/28 (28.57%)  10
Constipation  1  5/14 (35.71%)  5 8/28 (28.57%)  9
Diarrhea  1  3/14 (21.43%)  4 6/28 (21.43%)  8
Dyspepsia  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Gastrointestinal disorders - Other  1  0/14 (0.00%)  0 4/28 (14.29%)  4
Abdominal pain  1  0/14 (0.00%)  0 3/28 (10.71%)  3
Mucositis oral  1  2/14 (14.29%)  2 1/28 (3.57%)  1
Dysphagia  1  0/14 (0.00%)  0 2/28 (7.14%)  2
Gastroesophageal reflux disease  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Bloating  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Fecal incontinence  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Gastritis  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Oral hemorrhage  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Oral pain  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Pancreatitis  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Stomach pain  1  1/14 (7.14%)  2 0/28 (0.00%)  0
General disorders     
Fatigue  1  8/14 (57.14%)  11 16/28 (57.14%)  18
Pain  1  3/14 (21.43%)  3 6/28 (21.43%)  8
Chills  1  1/14 (7.14%)  1 2/28 (7.14%)  2
Fever  1  2/14 (14.29%)  2 0/28 (0.00%)  0
General Disorders - Other  1  1/14 (7.14%)  1 2/28 (7.14%)  2
Flu like symptoms  1  0/14 (0.00%)  0 2/28 (7.14%)  2
Malaise  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Non-cardiac chest pain  1  0/14 (0.00%)  0 2/28 (7.14%)  2
Edema face  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Edema limbs  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Edema trunk  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Facial pain  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Gait disturbance  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Immune system disorders     
Allergic reaction  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Infections and infestations     
Infections and infestations - Other  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Lung infection  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Upper respiratory infection  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Urinary tract infection  1  0/14 (0.00%)  0 1/28 (3.57%)  2
Vaginal infection  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Injury, poisoning and procedural complications     
Bruising  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Fracture  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Investigations     
Aspartate aminotransferase increased  1  1/14 (7.14%)  1 8/28 (28.57%)  10
White blood cell decreased  1  7/14 (50.00%)  14 2/28 (7.14%)  5
Alanine aminotransferase increased  1  1/14 (7.14%)  1 7/28 (25.00%)  9
Lymphocyte count decreased  1  5/14 (35.71%)  15 5/28 (17.86%)  15
Platelet count decreased  1  4/14 (28.57%)  9 4/28 (14.29%)  7
Blood bilirubin increased  1  1/14 (7.14%)  1 6/28 (21.43%)  6
Weight loss  1  0/14 (0.00%)  0 6/28 (21.43%)  6
Alkaline phosphatase increased  1  0/14 (0.00%)  0 5/28 (17.86%)  6
Neutrophil count decreased  1  5/14 (35.71%)  8 0/28 (0.00%)  0
Creatinine increased  1  0/14 (0.00%)  0 4/28 (14.29%)  7
Electrocardiogram QT corrected interval prolonged  1  1/14 (7.14%)  1 1/28 (3.57%)  1
INR increased  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Investigations - Other  1  2/14 (14.29%)  3 1/28 (3.57%)  1
Cardiac troponin I increased  1  1/14 (7.14%)  1 0/28 (0.00%)  0
CD4 lymphocytes decreased  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Metabolism and nutrition disorders     
Anorexia  1  7/14 (50.00%)  7 12/28 (42.86%)  13
Hyponatremia  1  2/14 (14.29%)  2 11/28 (39.29%)  19
Hyperglycemia  1  3/14 (21.43%)  3 8/28 (28.57%)  10
Hypoalbuminemia  1  4/14 (28.57%)  4 8/28 (28.57%)  14
Dehydration  1  4/14 (28.57%)  6 4/28 (14.29%)  4
Hypokalemia  1  2/14 (14.29%)  2 6/28 (21.43%)  9
Hypocalcemia  1  2/14 (14.29%)  2 5/28 (17.86%)  5
Hyperkalemia  1  1/14 (7.14%)  1 2/28 (7.14%)  2
Hypomagnesemia  1  1/14 (7.14%)  1 2/28 (7.14%)  4
Hypophosphatemia  1  0/14 (0.00%)  0 2/28 (7.14%)  2
Metabolism and nutrition disorders - Other  1  0/14 (0.00%)  0 2/28 (7.14%)  2
Alkalosis  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Hypercalcemia  1  0/14 (0.00%)  0 1/28 (3.57%)  3
Hypernatremia  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Hypoglycemia  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  2/14 (14.29%)  2 3/28 (10.71%)  7
Back pain  1  1/14 (7.14%)  1 3/28 (10.71%)  4
Generalized muscle weakness  1  1/14 (7.14%)  1 3/28 (10.71%)  4
Bone pain  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Muscle weakness lower limb  1  0/14 (0.00%)  0 2/28 (7.14%)  2
Neck pain  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Flank pain  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Muscle weakness left-sided  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Musculoskeletal and connective tissue disorder - Other  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other  1  1/14 (7.14%)  1 8/28 (28.57%)  8
Nervous system disorders     
Dizziness  1  2/14 (14.29%)  4 3/28 (10.71%)  3
Headache  1  3/14 (21.43%)  5 2/28 (7.14%)  5
Peripheral sensory neuropathy  1  0/14 (0.00%)  0 3/28 (10.71%)  3
Lethargy  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Amnesia  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Dysarthria  1  0/14 (0.00%)  0 1/28 (3.57%)  3
Nervous system disorders - Other  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Paresthesia  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Phantom pain  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Syncope  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Psychiatric disorders     
Confusion  1  2/14 (14.29%)  2 1/28 (3.57%)  1
Insomnia  1  0/14 (0.00%)  0 2/28 (7.14%)  2
Anxiety  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Renal and urinary disorders     
Urinary incontinence  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  3/14 (21.43%)  3 8/28 (28.57%)  8
Cough  1  4/14 (28.57%)  4 6/28 (21.43%)  6
Epistaxis  1  2/14 (14.29%)  3 2/28 (7.14%)  2
Hypoxia  1  1/14 (7.14%)  1 3/28 (10.71%)  4
Pneumonitis  1  2/14 (14.29%)  2 2/28 (7.14%)  2
Pleural effusion  1  1/14 (7.14%)  1 2/28 (7.14%)  2
Productive cough  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Sore throat  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Bronchial obstruction  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Bronchopulmonary hemorrhage  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Hoarseness  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Nasal congestion  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Pleuritic pain  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Postnasal drip  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Pulmonary hypertension  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Wheezing  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  2/14 (14.29%)  2 1/28 (3.57%)  1
Hyperhidrosis  1  0/14 (0.00%)  0 2/28 (7.14%)  2
Skin and subcutaneous tissue disorders - Other  1  1/14 (7.14%)  1 1/28 (3.57%)  1
Hypohidrosis  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Pruritus  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Rash maculo-papular  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Skin hyperpigmentation  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Skin ulceration  1  1/14 (7.14%)  1 0/28 (0.00%)  0
Vascular disorders     
Hypotension  1  1/14 (7.14%)  1 4/28 (14.29%)  4
Hypertension  1  2/14 (14.29%)  3 1/28 (3.57%)  1
Thromboembolic event  1  1/14 (7.14%)  4 1/28 (3.57%)  1
Vascular disorders - Other  1  2/14 (14.29%)  2 0/28 (0.00%)  0
Flushing  1  1/14 (7.14%)  1 2/28 (7.14%)  2
Hot flashes  1  0/14 (0.00%)  0 1/28 (3.57%)  1
Superior vena cava syndrome  1  0/14 (0.00%)  0 1/28 (3.57%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
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. Alberto Chiappori
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-2158
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01533181     History of Changes
Obsolete Identifiers: NCT01387386
Other Study ID Numbers: NCI-2012-00245
NCI-2012-00245 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000724806
MCC-16628
MCC 16628 ( Other Identifier: Moffitt Cancer Center )
8873 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM00099 ( U.S. NIH Grant/Contract )
N01CM00100 ( U.S. NIH Grant/Contract )
P30CA076292 ( U.S. NIH Grant/Contract )
First Submitted: February 11, 2012
First Posted: February 15, 2012
Results First Submitted: December 10, 2015
Results First Posted: January 14, 2016
Last Update Posted: January 14, 2016