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Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT01012362
Recruitment Status : Terminated (PI left institution.)
First Posted : November 13, 2009
Results First Posted : June 26, 2017
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Lung Cancer
Colon Cancer
Pancreatic Cancer
Head and Neck Cancer
Kidney Cancer
Sarcoma
Hepatocellular Cancer
Interventions Drug: Pazopanib
Drug: Ixabepilone
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Dose Level 1 Arm 1: Dose Level 2 Arm 1: Dose Level 3 Arm 1: Dose Level 4 Arm 2
Hide Arm/Group Description Pazopanib 400mg - Ixabepilone 32mg/m2 Pazopanib 400mg - Ixabepilone 40mg/m2 Pazopanib 600mg - Ixabepilone 32 mg/m2 Pazopanib 800mg - Ixabepilone 32 mg//m2 Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
Period Title: Overall Study
Started 9 6 3 4 9
Completed 9 6 3 4 9
Not Completed 0 0 0 0 0
Arm/Group Title Arm 1: Dose Level 1 Arm 1: Dose Level 2 Arm 1: Dose Level 3 Arm 1: Dose Level 4 Arm 2 Total
Hide Arm/Group Description Pazopanib 400mg - Ixabepilone 32mg/m2 Pazopanib 400mg - Ixabepilone 40mg/m2 Pazopanib 600mg - Ixabepilone 32 mg/m2 Pazopanib 800mg - Ixabepilone 32 mg//m2 Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population. Total of all reporting groups
Overall Number of Baseline Participants 9 6 3 4 9 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 3 participants 4 participants 9 participants 31 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
6
  66.7%
5
  83.3%
3
 100.0%
3
  75.0%
7
  77.8%
24
  77.4%
>=65 years
3
  33.3%
1
  16.7%
0
   0.0%
1
  25.0%
2
  22.2%
7
  22.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 3 participants 4 participants 9 participants 31 participants
Female
6
  66.7%
1
  16.7%
1
  33.3%
1
  25.0%
2
  22.2%
11
  35.5%
Male
3
  33.3%
5
  83.3%
2
  66.7%
3
  75.0%
7
  77.8%
20
  64.5%
1.Primary Outcome
Title The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination
Hide Description The optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for > 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC > 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.
Time Frame Week 3 of each dose level
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Arm 1 Participants
Hide Arm/Group Description:
All participants who received at least one cycle of one of the following 4 dose levels: Dose Level 1: Pazopanib 400mg - Ixabepilone 32mg/m2; Dose Level 2: Pazopanib 400mg - Ixabepilone 40mg/m2; Dose Level 3: Pazopanib 600mg - Ixabepilone 32 mg/m2; or Dose Level 4: Pazopanib 800mg - Ixabepilone 32 mg//m2.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: Dose Level
3
2.Primary Outcome
Title Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Hide Description A DLT was defined as one of the following events occurring during cycle 1: (1) grade 4 or greater treatment-related hematologic toxicity for >7 days; (2) grade 3 or greater treatment-related clinical non-hematologic toxicity (excluding >/= grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis); or (3) delay of starting cycle 2 treatment by >2 weeks due to incomplete hematologic recovery (absolute neutrophil count > 1.5 X 10^9/L or platelets >100 X 10^9/L) or unresolved treatment-related grade 3 or greater non-hematologic toxicity. Adverse events were classified according to Common Terminology Criteria for Adverse Events V 3.0 (CTCAE).
Time Frame Week 3 of each dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
6 participants were included at Dose Level 1 to confirm safety after escalation to Dose level 2, but are grouped with the original 3 participants enrolled at Dose Level 1.
Arm/Group Title Arm 1: Dose Level 1 Arm 1: Dose Level 2 Arm 1: Dose Level 3 Arm 1: Dose Level 4 Arm 2: Dose Level 3
Hide Arm/Group Description:
400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.
400 milligrams (mg) of Pazopanib and Ixabepilone 40 mg/m2
600 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
800 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
6400 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
Overall Number of Participants Analyzed 9 6 3 4 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
  50.0%
0
   0.0%
1
  25.0%
2
  22.2%
3.Secondary Outcome
Title Number of Participants With Treatment-Related Adverse Events
Hide Description Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.
Time Frame Up to 30 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4
Hide Arm/Group Description:
Pazopanib 400mg - Ixabepilone 32mg/m2
Pazopanib 400mg - Ixabepilone 40mg/m2
Pazopanib 600mg - Ixabepilone 32 mg/m2
Pazopanib 800mg - Ixabepilone 32 mg//m2
Overall Number of Participants Analyzed 9 6 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
9
 100.0%
6
 100.0%
12
 100.0%
4
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4
Hide Arm/Group Description Pazopanib 400mg - Ixabepilone 32mg/m2 Pazopanib 400mg - Ixabepilone 40mg/m2 Pazopanib 600mg - Ixabepilone 32 mg/m2 Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined. Pazopanib 800mg - Ixabepilone 32 mg//m2
All-Cause Mortality
Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      3/6 (50.00%)      7/12 (58.33%)      3/4 (75.00%)    
Blood and lymphatic system disorders         
Febrile Neutropenia  1/9 (11.11%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Decreased Platelets  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Cardiac disorders         
Atrial fibrillation  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Gastrointestinal disorders         
Diarrhea  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Abdominal Pain  1/9 (11.11%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
General disorders         
Fatigue  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Death due to Disease Progression  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Chest Wall Pain  1/9 (11.11%)  0/6 (0.00%)  0/12 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Infection  0/9 (0.00%)  1/6 (16.67%)  3/12 (25.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle Weakness  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Nervous system disorders         
Syncope  1/9 (11.11%)  0/6 (0.00%)  0/12 (0.00%)  0/4 (0.00%) 
Seizure  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Psychiatric disorders         
Confusion  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Obstruction of Airway  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Respiratory Failure  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/9 (100.00%)      6/6 (100.00%)      12/12 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders         
Anemia  2/9 (22.22%)  3/6 (50.00%)  2/12 (16.67%)  1/4 (25.00%) 
Decrease Platelets  1/9 (11.11%)  2/6 (33.33%)  0/12 (0.00%)  1/4 (25.00%) 
Fever with Neutropenia  1/9 (11.11%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Hemoglobin, NOS  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Leukocytes, NOS  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Leukocytopenia  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Lymphedema  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Neutropenia  6/9 (66.67%)  6/6 (100.00%)  4/12 (33.33%)  1/4 (25.00%) 
Neutrophils, NOS  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%)  0
Platelets, NOS  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Cardiac disorders         
Atrial Fibrillation  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Left Ventricular Systolic Dysfunction  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Endocrine disorders         
Hypothyroidism  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Eye disorders         
Blurred Vision  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Edema, Periorbital  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Eye Pain  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Eye Twitch  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Gastrointestinal disorders         
Abdominal Bloating  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Abdominal Pain  0/9 (0.00%)  0/6 (0.00%)  6/12 (50.00%)  0/4 (0.00%) 
Bleeding Gums  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Constipation  2/9 (22.22%)  2/6 (33.33%)  1/12 (8.33%)  2/4 (50.00%) 
Diarrhea  3/9 (33.33%)  2/6 (33.33%)  6/12 (50.00%)  0/4 (0.00%) 
Dysphagia  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  1/4 (25.00%) 
Hemorrhoids  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Mucositis  1/9 (11.11%)  0/6 (0.00%)  2/12 (16.67%)  1/4 (25.00%) 
Nausea  5/9 (55.56%)  3/6 (50.00%)  9/12 (75.00%)  2/4 (50.00%) 
Reflux  1/9 (11.11%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Stomach Pain  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Taste Alteration  1/9 (11.11%)  1/6 (16.67%)  1/12 (8.33%)  0/4 (0.00%) 
Throat Pain  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Vomiting  3/9 (33.33%)  2/6 (33.33%)  6/12 (50.00%)  2/4 (50.00%) 
General disorders         
Bleeding Neck Wound  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Chest/Rib Pain  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Chills  1/9 (11.11%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Ear/Head  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Fatigue  4/9 (44.44%)  4/6 (66.67%)  10/12 (83.33%)  3/4 (75.00%) 
Fever  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Flu-Like Syndrome  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Increased Sweating  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Jaw/Neck Wound Pain  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Joint Pain  1/9 (11.11%)  1/6 (16.67%)  4/12 (33.33%)  1/4 (25.00%) 
Leg Pain  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Neck Pain  1/9 (11.11%)  0/6 (0.00%)  0/12 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Fungal Infection, Feet  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Infection, Lung  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Infection, NOS  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Infection, Port Incision  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Infection, Urinary  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Osteomyelitis  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Pneumonia  1/9 (11.11%)  0/6 (0.00%)  2/12 (16.67%)  1/4 (25.00%) 
Sinus Infection  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  1/4 (25.00%) 
Upper Respiratory Infection  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Viral Infection, NOS  1/9 (11.11%)  0/6 (0.00%)  0/12 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications         
Increased Liver Enzyme, AST  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Investigations         
Increased Liver Enzyme, ALT  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Partial Thromboplastin Time, NOS  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Weight Loss  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders         
Anorexia  3/9 (33.33%)  3/6 (50.00%)  5/12 (41.67%)  2/4 (50.00%) 
Dehydration  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  1/4 (25.00%) 
Hypokalemia  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Hypomagnesemia  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Hyponatremia  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Ankle Pain  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Arthralgia  1/9 (11.11%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Back Pain  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Bilateral Leg Cramping  1/9 (11.11%)  0/6 (0.00%)  0/12 (0.00%)  0/4 (0.00%) 
Bone Pain  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Foot Pain  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Fracture, Arm  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Genreralized Body Aches  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Hand Pain  1/9 (11.11%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Joint Swelling  1/9 (11.11%)  0/6 (0.00%)  0/12 (0.00%)  0/4 (0.00%) 
Muscle Aches  1/9 (11.11%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Muscle Spasms  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Weakness, NOS  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  1/4 (25.00%) 
Nervous system disorders         
Burning Sensation, Hand  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Dizziness  2/9 (22.22%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Headache  1/9 (11.11%)  1/6 (16.67%)  4/12 (33.33%)  1/4 (25.00%) 
Neuropathy, NOS  1/9 (11.11%)  2/6 (33.33%)  0/12 (0.00%)  0/4 (0.00%) 
Peripheral Neuropathy  0/9 (0.00%)  0/6 (0.00%)  4/12 (33.33%)  1/4 (25.00%) 
Seizure  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Syncope  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Tremor  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Psychiatric disorders         
Anxiety  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Confusion  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Insomnia  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Renal and urinary disorders         
Hematuria  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Proteinuria  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Urinary Leakage  1/9 (11.11%)  0/6 (0.00%)  0/12 (0.00%)  0/4 (0.00%) 
Reproductive system and breast disorders         
Erectile Dysfunction  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Bronchitis  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Cough  1/9 (11.11%)  2/6 (33.33%)  1/12 (8.33%)  1/4 (25.00%) 
Dyspnea  0/9 (0.00%)  2/6 (33.33%)  1/12 (8.33%)  0/4 (0.00%) 
Epistaxis  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  1/4 (25.00%) 
Hemoptysis  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Hiccups  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Hoarseness  1/9 (11.11%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Hypoxia  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
Increased Trachea Secretions  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Nasal Congestion  0/9 (0.00%)  1/6 (16.67%)  1/12 (8.33%)  1/4 (25.00%) 
Respiratory Arrest  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Rhinnorhea  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  1/4 (25.00%) 
Wheezing  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia  1/9 (11.11%)  3/6 (50.00%)  4/12 (33.33%)  0/4 (0.00%) 
Delayed Wound Healing  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Dry Skin  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Erythema, Arm  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Flushing  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Folliculitis, Leg  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Hypopigmentation, Eyelashes and Eyebrows  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Hypopigmentation, Hair  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/4 (0.00%) 
Rash  2/9 (22.22%)  0/6 (0.00%)  3/12 (25.00%)  0/4 (0.00%) 
Scrotal Cysts  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Skin Breakdown near Gastrostomy Tube  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Weepy Scalp  0/9 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/4 (0.00%) 
Vascular disorders         
Deep Vein Thrombosis  1/9 (11.11%)  0/6 (0.00%)  0/12 (0.00%)  0/4 (0.00%) 
Edema, Glans Penis  0/9 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/4 (25.00%) 
Edema, Limbs  0/9 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  1/4 (25.00%) 
Hypertension  0/9 (0.00%)  0/6 (0.00%)  3/12 (25.00%)  1/4 (25.00%) 
Hypotension  0/9 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/4 (0.00%) 
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. Arkadiusz Dudek
Organization: Masonic Cancer Center, University of Minnesota
Phone: 651-254-3321
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01012362     History of Changes
Other Study ID Numbers: 2009LS001
0906M68402 ( Other Identifier: Institutional Review Board, University of Minnesota )
NCI-2009-01444 ( Registry Identifier: National Cancer Institute website )
First Submitted: November 12, 2009
First Posted: November 13, 2009
Results First Submitted: April 11, 2017
Results First Posted: June 26, 2017
Last Update Posted: December 28, 2017