Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00495625
• Collaborator: Pfizer (Industry)
• Enrollment: 33
• Location: 1
• Arm: 1
• Duration (Months): 50
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

An open label multi-site phase II clinical trial of dose escalated sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer	Drug: Sunitinib Malate	Phase 2

Detailed Description

An open label multi-site phase II clinical trial of sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Sunitinib malate will be dispensed as capsules at the beginning of each treatment cycle. The dose may be escalated at the investigator's discretion. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.

A follow up visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel (including liver function tests) and alpha-feto protein (when indicated) will be obtained at every scheduled follow up visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Open-Label Study of Sunitinib Malate (SUO11248) in Adult Subjects With Metastatic and/or Surgically Unresectable Hepatocellular Cancers (HCC)
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sunitinib Malate (SUO11248) Treatment	Drug: Sunitinib Malate; Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles will be 37.5 mg daily for 28 days, every 42 days. Dose may be escalated to 50 mg daily for 28 days at the treating investigator's discretion.; Other Names: SU011248 Sutent

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Partial Response (PR) at Interim Analysis [On Treatment to Off Study - average of 7 months per participant]

   Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].

2. Number of Participants With Stable Disease (SD) at Interim Analysis [On Treatment to Off Study - average of 7 months per participant]

   Stable Disease (SD) Rate at Interim Analysis. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].

3. Number of Participants With Progressive Disease (PD) at Interim Analysis [On Treatment to Off Study - average of 7 months per participant]

   Progressive Disease Rate. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].

Secondary Outcome Measures

1. Participant Time to Tumor Progression (TTP) [On Treatment to Off Study - average of 7 months per participant]

   Investigators planned to determine the time to tumor progression (TTP) of sunitinib malate in the treatment in unresectable Hepatocellular Cancers (HCC). TTP is defined as the duration of time from start of treatment to time of progression.

2. Number of Participants With Overall Survival (OS) [On Treatment to Off Study - average of 7 months per participant]

   Overall survival (OS) of sunitinib malate in the treatment in unresectable HCC

3. Number of Participants With Serious Adverse Events (SAEs) [On Treatment to Off Study - average of 7 months per participant]

   The toxicity of sunitinib malate in the treatment in unresectable HCC

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.

• Adequate organ function as defined by the following criteria:

• Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy

• Total serum bilirubin less than or equal to 1.5 x ULN

• Absolute neutrophil count (ANC) more than or equal to 1500/mcL

• Platelets more than or equal to 100,000/mcL

• Hemoglobin more than or equal to 9.0 g/dL

• Serum calcium less than or equal to 12.0 mg/dL

• Serum creatinine less than or equal to 1.5 x ULN

• Biopsy-proven disease

• Measurable disease radiographically

• Disease that is deemed surgically unresectable (awaiting orthotopic hepatic transplantation allowable) and/or metastatic

• Age greater or equal to 18 years

• Life expectancy greater than 16 weeks

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Karnofsky score > 60%)

Exclusion Criteria:

• Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment

• NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment

• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening computed tomography (CT) or magnetic resonance imaging (MRI) scan

• Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.

• Known brain metastases

• Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2

• Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 450msec for males or > 470 msec for females

• Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy)

• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication

• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection

• Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. Quality of Life (QOL), are allowed

• Concomitant use of ketoconazole or other agents known to induce CYP3A4

• Concomitant use of theophylline and phenobarbital and/or other agents metabolized by the cytochrome P450 system

• Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg po daily for thrombo prophylaxis is allowed)

• Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.

• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612

Sponsors and Collaborators

• H. Lee Moffitt Cancer Center and Research Institute
• Pfizer

Investigators

• Principal Investigator: Jonathan Strosberg, MD, H. Lee Moffitt Cancer Center and Research Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• H Lee Moffitt Cancer Center & Research Institute website

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT00495625
• Other Study ID Numbers: MCC-14733; Pfizer #2005-0880
• First Posted: Jul 3, 2007
• Last Update Posted: Mar 27, 2012
• Last Verified: Dec 1, 2011

• Keywords provided by H. Lee Moffitt Cancer Center and Research Institute: Hepatocellular cancer (HCC); Sunitinib malate; Vascular endothelial growth factor (VEGF); Platelet-derived growth factor (PDGF); Tyrosine kinases; Liver
• Additional relevant MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular; Sunitinib

Study Results

Participant Flow

Recruitment Details	All patients with unresectable or metastatic hepatocellular cancer (HCC) seen at the Moffitt Cancer Center Gastrointestinal (GI) Clinic were screened for eligibility to be enrolled in the study.

Arm/Group Title	Sunitinib Malate (SUO11248) Treatment
Arm/Group Description	Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
Period Title: Overall Study
STARTED	33
COMPLETED	23
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Sunitinib Malate (SUO11248) Treatment
Arm/Group Description	Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
Overall Participants	33
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	21 63.6%
>=65 years	12 36.4%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	60.65
Sex: Female, Male (Count of Participants)
Female	7 21.2%
Male	26 78.8%
Region of Enrollment (participants) [Number]
United States	33 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Partial Response (PR) at Interim Analysis
Description	Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].
Time Frame	On Treatment to Off Study - average of 7 months per participant

Outcome Measure Data

Analysis Population Description

17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.

Arm/Group Title	Sunitinib Malate (SUO11248) Treatment
Arm/Group Description	Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
Measure Participants	17
Number [participants]	1 3%

2. Secondary Outcome

Title	Participant Time to Tumor Progression (TTP)
Description	Investigators planned to determine the time to tumor progression (TTP) of sunitinib malate in the treatment in unresectable Hepatocellular Cancers (HCC). TTP is defined as the duration of time from start of treatment to time of progression.
Time Frame	On Treatment to Off Study - average of 7 months per participant

Outcome Measure Data

Analysis Population Description

Not analyzed. The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.

Arm/Group Title	Sunitinib Malate (SUO11248) Treatment
Arm/Group Description	Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
Measure Participants	0

3. Secondary Outcome

Title	Number of Participants With Overall Survival (OS)
Description	Overall survival (OS) of sunitinib malate in the treatment in unresectable HCC
Time Frame	On Treatment to Off Study - average of 7 months per participant

Outcome Measure Data

Analysis Population Description

Participants who had not expired on their off study date.

Arm/Group Title	Sunitinib Malate (SUO11248) Treatment
Arm/Group Description	Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
Measure Participants	33
Number [participants]	20 60.6%

4. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs)
Description	The toxicity of sunitinib malate in the treatment in unresectable HCC
Time Frame	On Treatment to Off Study - average of 7 months per participant

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	Sunitinib Malate (SUO11248) Treatment
Arm/Group Description	Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
Measure Participants	33
Number [participants]	11 33.3%

5. Primary Outcome

Title	Number of Participants With Stable Disease (SD) at Interim Analysis
Description	Stable Disease (SD) Rate at Interim Analysis. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].
Time Frame	On Treatment to Off Study - average of 7 months per participant

Outcome Measure Data

Analysis Population Description

17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.

Arm/Group Title	Sunitinib Malate (SUO11248) Treatment
Arm/Group Description	Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
Measure Participants	17
Number [participants]	6 18.2%

6. Primary Outcome

Title	Number of Participants With Progressive Disease (PD) at Interim Analysis
Description	Progressive Disease Rate. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].
Time Frame	On Treatment to Off Study - average of 7 months per participant

Outcome Measure Data

Analysis Population Description

17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.

Arm/Group Title	Sunitinib Malate (SUO11248) Treatment
Arm/Group Description	Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
Measure Participants	17
Number [participants]	8 24.2%

Adverse Events

Time Frame	3 Years and 4 Months
Adverse Event Reporting Description	First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
Arm/Group Title	Sunitinib Malate (SUO11248) Treatment
Arm/Group Description	Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
All Cause Mortality
	Sunitinib Malate (SUO11248) Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib Malate (SUO11248) Treatment
	Affected / at Risk (%)	# Events
Total	11/33 (33.3%)
Blood and lymphatic system disorders
Hemoglobin	1/33 (3%)	1
Gastrointestinal disorders
Ascites - Non-malignant	1/33 (3%)	1
Dehydration	1/33 (3%)	1
Diarrhea	1/33 (3%)	1
Nausea	1/33 (3%)	1
Vomiting	1/33 (3%)	1
General disorders
Death - Disease Progression	4/33 (12.1%)	4
Sudden Death	1/33 (3%)	1
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Wound	1/33 (3%)	1
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)	1/33 (3%)	1
Sodium, serum -low (hyponatremia)	1/33 (3%)	1
Sodium, serum-low (hyponatremia)	1/33 (3%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)	1/33 (3%)	1
Vascular disorders
Thrombosis/thrombus/embolism	1/33 (3%)	1
Other (Not Including Serious) Adverse Events
	Sunitinib Malate (SUO11248) Treatment
	Affected / at Risk (%)	# Events
Total	31/33 (93.9%)
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)	9/33 (27.3%)	18
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)	8/33 (24.2%)	15
Platelets	7/33 (21.2%)	14
Hemoglobin	4/33 (12.1%)	6
Blood/Bone Marrow - Other	2/33 (6.1%)	2
Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic synd	10/33 (30.3%)	21
Coagulation - Other	1/33 (3%)	1
INR (International Normalized Ratio of prothrombin time)	1/33 (3%)	1
Edema: limb	6/33 (18.2%)	6
Edema: head and neck	1/33 (3%)	1
Edema: trunk/genital	1/33 (3%)	1
Cardiac disorders
Hypertension	3/33 (9.1%)	3
Supraventricular and nodal arrhythmia - Sinus tachycardia	1/33 (3%)	1
Endocrine disorders
Thyroid function, high (hyperthyroidism, thyrotoxicosis)	2/33 (6.1%)	2
Thyroid function, low (hypothyroidism)	1/33 (3%)	1
Eye disorders
Watery eye (epiphora, tearing)	2/33 (6.1%)	2
Gastrointestinal disorders
Diarrhea	15/33 (45.5%)	22
Nausea	15/33 (45.5%)	18
Anorexia	12/33 (36.4%)	13
Mucositis/stomatitis (clinical exam) - Oral cavity	9/33 (27.3%)	11
Taste alteration (dysgeusia)	8/33 (24.2%)	12
Vomiting	7/33 (21.2%)	8
Heartburn/dyspepsia	6/33 (18.2%)	6
Gastrointestinal - Other	5/33 (15.2%)	7
Dehydration	3/33 (9.1%)	3
Gastritis (including bile reflux gastritis)	3/33 (9.1%)	3
Ascites (non-malignant)	1/33 (3%)	1
Constipation	2/33 (6.1%)	2
Distension/bloating, abdominal	2/33 (6.1%)	2
Flatulence	2/33 (6.1%)	3
Dysphagia (difficulty swallowing)	1/33 (3%)	1
General disorders
Fatigue (asthenia, lethargy, malaise)	19/33 (57.6%)	22
Fever	3/33 (9.1%)	3
Insomnia	3/33 (9.1%)	3
Rigors/chills	2/33 (6.1%)	2
Weight loss	2/33 (6.1%)	2
Sweating (diaphoresis)	1/33 (3%)	2
Weight gain	1/33 (3%)	1
Constitutional symptoms - Other	4/33 (12.1%)	5
Pain - Abdomen NOS	7/33 (21.2%)	9
Pain - Head/headache	5/33 (15.2%)	7
Pain - Back	3/33 (9.1%)	3
Pain - Muscle	3/33 (9.1%)	3
Pain - Extremity-limb	2/33 (6.1%)	3
Pain - Bone	1/33 (3%)	1
Pain - Joint	1/33 (3%)	1
Pain - Oral-gums	1/33 (3%)	1
Paiin - Other	1/33 (3%)	1
Pain - Testicle	1/33 (3%)	1
Pain - Tumor	1/33 (3%)	3
Dizziness	1/33 (3%)	2
Extrapyramidal/involuntary movement/restlessness	1/33 (3%)	1
Memory impairment	1/33 (3%)	1
Neuropathy: motor	1/33 (3%)	1
Somnolence/depressed level of consciousness	1/33 (3%)	1
Syncope (fainting)	1/33 (3%)	1
Tremor	1/33 (3%)	1
Flu-like syndrome	1/33 (3%)	1
Hepatobiliary disorders
Cholecystitis	1/33 (3%)	2
Infections and infestations
Febrile neutropenia	1/33 (3%)	1
Infection with noral ANCl or lGrade 1 or 2 neutrophils - Urinary tract NOS	1/33 (3%)	1
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)	8/33 (24.2%)	8
Bilirubin (hyperbilirubinemia)	4/33 (12.1%)	5
ALT, SGPT(serum glutamic pyruvic transaminase)	3/33 (9.1%)	5
Potassium, serum-low (hypokalemia)	2/33 (6.1%)	2
Alkaline phosphatase	2/33 (6.1%)	2
Glucose, serum-low (hypoglycemia)	1/33 (3%)	1
Potassium, serum-high (hyperkalemia)	1/33 (3%)	1
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)	1/33 (3%)	1
Muscle weakness	1/33 (3%)	1
Muscle weakness	1/33 (3%)	1
Musculoskeletal/Soft Tissue - Other	1/33 (3%)	1
Psychiatric disorders
Mental status	2/33 (6.1%)	2
Mood alteration - Depression	2/33 (6.1%)	2
Cognitive disturbance	1/33 (3%)	1
Mood alteration - Anxiety	1/33 (3%)	1
Renal and urinary disorders
Renal/Genitourinary - Other	2/33 (6.1%)	2
Incontinence, urinary	1/33 (3%)	1
Urinary retention (including neurogenic bladder)	1/33 (3%)	1
Urine color change	1/33 (3%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	7/33 (21.2%)	7
Cough	2/33 (6.1%)	2
Hemorrhage, pulmonary/upper respiratory - Nose	1/33 (3%)	2
Skin and subcutaneous tissue disorders
Hyperpigmentation	7/33 (21.2%)	9
Rash: hand-foot skin reaction	6/33 (18.2%)	11
Dermatology/Skin - Other	5/33 (15.2%)	6
Bruising (in absence of Grade 3 or 4 thrombocytopenia)	3/33 (9.1%)	3
Rash/desquamation	2/33 (6.1%)	5
Dry skin	1/33 (3%)	1
Pruritus/itching	1/33 (3%)	1
Rash: acne/acneiform	1/33 (3%)	1
Vascular disorders
Phlebitis (including superficial thrombosis)	1/33 (3%)	1

Limitations/Caveats

The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.

More Information

Certain Agreements

All Principal Investigators ARE 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.