Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01012362
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 31
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a Phase I study; dose escalating the combination of pazopanib when taken daily and ixabepilone when administered on day 1 of a 3 week treatment course.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Lung Cancer; Colon Cancer; Pancreatic Cancer; Head and Neck Cancer; Kidney Cancer; Sarcoma; Hepatocellular Cancer	Drug: Pazopanib; Drug: Ixabepilone	Phase 1

Detailed Description

Treatment with ixabepilone will be given at an assigned dose as a 3 hour intravenous infusion on day 1 of a 21 day cycle. Treatment with pazopanib will be given at an assigned dose by mouth once a day, beginning on day 1 and continuing daily. Disease assessment will be done every 2 cycles (6 weeks) with treatment continuing until disease progression, unacceptable toxicity or patient refusal.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of Pazopanib and Ixabepilone in Patients With Solid Tumors
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Optimum Tolerated Dose Determination Patient receives assigned dose level: Dose Level 1 = 400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 2 = 400 milligrams (mg) of pazopanib and ixabepilone 40 mg/m2. Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 4 = 800 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.	Drug: Pazopanib; Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.; Other Names: Pazopanib hydrochloride GW786034B ; Drug: Ixabepilone; Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle; Other Names: IXEMPRA(TM)
Experimental: Optimum Tolerated Dose Confirmation Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.	Drug: Pazopanib; Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.; Other Names: Pazopanib hydrochloride GW786034B ; Drug: Ixabepilone; Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle; Other Names: IXEMPRA(TM)

Outcome Measures

Primary Outcome Measures

1. The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination [Week 3 of each dose level]

   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.

2. Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) [Week 3 of each dose]

   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).

Secondary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events [Up to 30 days post treatment]

   Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of advanced non-hematologic solid tumor malignancy, including, but not limited to breast, lung, colon, pancreatic, head and neck, kidney or sarcoma that has failed or become intolerant to standard therapy and is no longer likely to respond to such therapy Effective with the August 2011 version of the protocol, enrollment is limited to squamous cell carcinoma of the head and neck (refer to section 1.4 for rationale). Note: Patients with a primary diagnosis of hepatocellular carcinoma will be eligible for enrollment into dose level 1 or 2 only, provided they met all other inclusion/exclusion criteria - the maximum tolerated dose (MTD) for pazopanib monotherapy in patients with hepatocellular cancer was found to be 600 mg daily.

• Measureable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST).

• Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed; however prior use of either pazopanib or ixabepilone alone or in combination is not allowed.

• At least 14 days must have elapsed since 1) previous systemic therapy (28 days for bevacizumab) before the 1st dose of study drug, 2) last dose of radiation therapy or surgery (28 days for major surgery).

• Patient must have recovered from the acute toxic effects of previous anti-cancer treatment prior to study enrollment.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

• Adequate organ function within 14 days of enrollment defined as:

• Absolute neutrophil count (ANC) >1.5 x 10^9/L

• Hemoglobin > or = 9 g/dL

• Platelets > or = 100 x 10^9/L

• Prothrombin time or international normalized ratio, and partial thromboplastin time (PTT) < or = 1.2 x upper limit of normal (ULN)

• Total bilirubin < or = ULN

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = 2.5 x ULN

• Serum creatinine < or = 1.5 mg/dL

• Urine protein to Creatinine Ratio < 1

• Total serum calcium < 12.0 mg/dL

• Men and women with child-bearing potential must adhere to protocol criteria to prevent conception during study

Exclusion Criteria:

• Women who are pregnant or nursing.

• Prior radiation to > =or = 30% of major bone marrow containing areas (pelvis, lumbar spine)

• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis

• Clinically significant gastrointestinal abnormalities that may increase the risk of GI bleeding or may affect absorption of investigational product

• History of another malignancy - must be at least 3 years disease-free

• Presence of uncontrolled infection

• Prolongation of corrected QT interval (QTc) > 480 msecs

• History of any one or more of the following cardiovascular conditions within the past 6 months:

• Cardiac angioplasty or stenting

• Myocardial infarction

• Unstable angina

• Coronary artery bypass graft surgery

• Symptomatic peripheral vascular disease

• Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)

• Poorly controlled hypertension

• History of cerebrovascular accident,pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months

• Prior major surgery or trauma within 28 days prior to 1st dose of study drug

• Evidence of active bleeding or bleeding diathesis

• Known endobronchial lesions or involvement of large pulmonary vessels by tumor

• Hemoptysis with 6 weeks of 1st dose of study drug

• Neuropathy Grade 1

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota
• GlaxoSmithKline

Investigators

• Principal Investigator: Arkaduisz Z Dudek, MD, Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT01012362
• Other Study ID Numbers: 2009LS001; 0906M68402; NCI-2009-01444
• First Posted: Nov 13, 2009
• Last Update Posted: Dec 28, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Masonic Cancer Center, University of Minnesota: Solid tumor malignancy; breast cancer; lung cancer; colon cancer; pancreatic cancer; head and neck cancer; kidney cancer; sarcoma; hepatocellular cancer
• Additional relevant MeSH terms: Pancreatic Neoplasms; Sarcoma; Head and Neck Neoplasms; Colonic Neoplasms; Kidney Neoplasms; Carcinoma, Renal Cell; Liver Neoplasms; Carcinoma, Hepatocellular

Study Results

Participant Flow

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
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

Baseline Characteristics

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
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 Participants	9	6	3	4	9	31
Age (Count of Participants)
<=18 years	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%	3 75%	7 77.8%	24 77.4%
>=65 years	3 33.3%	1 16.7%	0 0%	1 25%	2 22.2%	7 22.6%
Sex: Female, Male (Count of Participants)
Female	6 66.7%	1 16.7%	1 33.3%	1 25%	2 22.2%	11 35.5%
Male	3 33.3%	5 83.3%	2 66.7%	3 75%	7 77.8%	20 64.5%

Outcome Measures

1. Primary Outcome

Title	The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Arm 1 Participants
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.
Measure Participants	22
Number [Dose Level]	3

2. Primary Outcome

Title	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
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

Outcome Measure Data

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
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
Measure Participants	9	6	3	4	9
Count of Participants [Participants]	0 0%	3 50%	0 0%	1 25%	2 22.2%

3. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events
Description	Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.
Time Frame	Up to 30 days post treatment

Outcome Measure Data

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
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
Measure Participants	9	6	12	4
Count of Participants [Participants]	9 100%	6 100%	12 400%	4 100%

Adverse Events

Arm/Group Title	Dose Level 1		Dose Level 2		Dose Level 3		Dose Level 4
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
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 (44.4%)		3/6 (50%)		7/12 (58.3%)		3/4 (75%)
Blood and lymphatic system disorders
Febrile Neutropenia	1/9 (11.1%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Decreased Platelets	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Cardiac disorders
Atrial fibrillation	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Gastrointestinal disorders
Diarrhea	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Abdominal Pain	1/9 (11.1%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
General disorders
Fatigue	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Death due to Disease Progression	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Chest Wall Pain	1/9 (11.1%)		0/6 (0%)		0/12 (0%)		0/4 (0%)
Infections and infestations
Infection	0/9 (0%)		1/6 (16.7%)		3/12 (25%)		0/4 (0%)
Musculoskeletal and connective tissue disorders
Muscle Weakness	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Nervous system disorders
Syncope	1/9 (11.1%)		0/6 (0%)		0/12 (0%)		0/4 (0%)
Seizure	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Psychiatric disorders
Confusion	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Respiratory, thoracic and mediastinal disorders
Obstruction of Airway	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Respiratory Failure	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Other (Not Including 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	9/9 (100%)		6/6 (100%)		12/12 (100%)		4/4 (100%)
Blood and lymphatic system disorders
Anemia	2/9 (22.2%)		3/6 (50%)		2/12 (16.7%)		1/4 (25%)
Decrease Platelets	1/9 (11.1%)		2/6 (33.3%)		0/12 (0%)		1/4 (25%)
Fever with Neutropenia	1/9 (11.1%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Hemoglobin, NOS	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Leukocytes, NOS	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Leukocytopenia	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Lymphedema	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Neutropenia	6/9 (66.7%)		6/6 (100%)		4/12 (33.3%)		1/4 (25%)
Neutrophils, NOS	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)	0
Platelets, NOS	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Cardiac disorders
Atrial Fibrillation	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Left Ventricular Systolic Dysfunction	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Endocrine disorders
Hypothyroidism	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Eye disorders
Blurred Vision	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Edema, Periorbital	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Eye Pain	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Eye Twitch	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Gastrointestinal disorders
Abdominal Bloating	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Abdominal Pain	0/9 (0%)		0/6 (0%)		6/12 (50%)		0/4 (0%)
Bleeding Gums	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Constipation	2/9 (22.2%)		2/6 (33.3%)		1/12 (8.3%)		2/4 (50%)
Diarrhea	3/9 (33.3%)		2/6 (33.3%)		6/12 (50%)		0/4 (0%)
Dysphagia	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		1/4 (25%)
Hemorrhoids	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Mucositis	1/9 (11.1%)		0/6 (0%)		2/12 (16.7%)		1/4 (25%)
Nausea	5/9 (55.6%)		3/6 (50%)		9/12 (75%)		2/4 (50%)
Reflux	1/9 (11.1%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Stomach Pain	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Taste Alteration	1/9 (11.1%)		1/6 (16.7%)		1/12 (8.3%)		0/4 (0%)
Throat Pain	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Vomiting	3/9 (33.3%)		2/6 (33.3%)		6/12 (50%)		2/4 (50%)
General disorders
Bleeding Neck Wound	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Chest/Rib Pain	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Chills	1/9 (11.1%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Ear/Head	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Fatigue	4/9 (44.4%)		4/6 (66.7%)		10/12 (83.3%)		3/4 (75%)
Fever	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Flu-Like Syndrome	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Increased Sweating	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Jaw/Neck Wound Pain	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Joint Pain	1/9 (11.1%)		1/6 (16.7%)		4/12 (33.3%)		1/4 (25%)
Leg Pain	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Neck Pain	1/9 (11.1%)		0/6 (0%)		0/12 (0%)		0/4 (0%)
Infections and infestations
Fungal Infection, Feet	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Infection, Lung	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Infection, NOS	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Infection, Port Incision	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Infection, Urinary	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Osteomyelitis	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Pneumonia	1/9 (11.1%)		0/6 (0%)		2/12 (16.7%)		1/4 (25%)
Sinus Infection	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		1/4 (25%)
Upper Respiratory Infection	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Viral Infection, NOS	1/9 (11.1%)		0/6 (0%)		0/12 (0%)		0/4 (0%)
Injury, poisoning and procedural complications
Increased Liver Enzyme, AST	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Investigations
Increased Liver Enzyme, ALT	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Partial Thromboplastin Time, NOS	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Weight Loss	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Metabolism and nutrition disorders
Anorexia	3/9 (33.3%)		3/6 (50%)		5/12 (41.7%)		2/4 (50%)
Dehydration	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		1/4 (25%)
Hypokalemia	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Hypomagnesemia	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Hyponatremia	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Musculoskeletal and connective tissue disorders
Ankle Pain	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Arthralgia	1/9 (11.1%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Back Pain	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Bilateral Leg Cramping	1/9 (11.1%)		0/6 (0%)		0/12 (0%)		0/4 (0%)
Bone Pain	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Foot Pain	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Fracture, Arm	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Genreralized Body Aches	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Hand Pain	1/9 (11.1%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Joint Swelling	1/9 (11.1%)		0/6 (0%)		0/12 (0%)		0/4 (0%)
Muscle Aches	1/9 (11.1%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Muscle Spasms	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Weakness, NOS	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		1/4 (25%)
Nervous system disorders
Burning Sensation, Hand	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Dizziness	2/9 (22.2%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Headache	1/9 (11.1%)		1/6 (16.7%)		4/12 (33.3%)		1/4 (25%)
Neuropathy, NOS	1/9 (11.1%)		2/6 (33.3%)		0/12 (0%)		0/4 (0%)
Peripheral Neuropathy	0/9 (0%)		0/6 (0%)		4/12 (33.3%)		1/4 (25%)
Seizure	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Syncope	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Tremor	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Psychiatric disorders
Anxiety	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Confusion	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Insomnia	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Renal and urinary disorders
Hematuria	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Proteinuria	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Urinary Leakage	1/9 (11.1%)		0/6 (0%)		0/12 (0%)		0/4 (0%)
Reproductive system and breast disorders
Erectile Dysfunction	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Respiratory, thoracic and mediastinal disorders
Bronchitis	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Cough	1/9 (11.1%)		2/6 (33.3%)		1/12 (8.3%)		1/4 (25%)
Dyspnea	0/9 (0%)		2/6 (33.3%)		1/12 (8.3%)		0/4 (0%)
Epistaxis	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		1/4 (25%)
Hemoptysis	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Hiccups	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Hoarseness	1/9 (11.1%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Hypoxia	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)
Increased Trachea Secretions	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Nasal Congestion	0/9 (0%)		1/6 (16.7%)		1/12 (8.3%)		1/4 (25%)
Respiratory Arrest	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Rhinnorhea	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		1/4 (25%)
Wheezing	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Skin and subcutaneous tissue disorders
Alopecia	1/9 (11.1%)		3/6 (50%)		4/12 (33.3%)		0/4 (0%)
Delayed Wound Healing	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Dry Skin	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Erythema, Arm	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Flushing	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Folliculitis, Leg	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Hypopigmentation, Eyelashes and Eyebrows	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Hypopigmentation, Hair	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		0/4 (0%)
Rash	2/9 (22.2%)		0/6 (0%)		3/12 (25%)		0/4 (0%)
Scrotal Cysts	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Skin Breakdown near Gastrostomy Tube	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Weepy Scalp	0/9 (0%)		0/6 (0%)		1/12 (8.3%)		0/4 (0%)
Vascular disorders
Deep Vein Thrombosis	1/9 (11.1%)		0/6 (0%)		0/12 (0%)		0/4 (0%)
Edema, Glans Penis	0/9 (0%)		0/6 (0%)		0/12 (0%)		1/4 (25%)
Edema, Limbs	0/9 (0%)		0/6 (0%)		2/12 (16.7%)		1/4 (25%)
Hypertension	0/9 (0%)		0/6 (0%)		3/12 (25%)		1/4 (25%)
Hypotension	0/9 (0%)		1/6 (16.7%)		0/12 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

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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.