Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00499252
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 51
• Locations: 20
• Arm: 1
• Patients Per Site: 2.6

Study Details

Study Description

Brief Summary

This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma	Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), in terms of frequency and duration of objective response, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.

2. Determine the toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

1. Determine the duration of progression-free survival and overall survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (paclitaxel albumin-stabilized nanoparticle) Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Other Names: ABI 007 ABI-007 Abraxane

Outcome Measures

Primary Outcome Measures

1. Tumor Response [every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels]

   Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

2. Frequency and Severity of Observed Adverse Effects [Every cycle during treatment and up to 5 years after completion of treatment]

Secondary Outcome Measures

1. Progression-free Survival [from study entry until disease progression, death or date of last contact.]

   Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

2. Overall Survival [from entry into the study to death or the date of last contact.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed diagnosis of 1 of the following:

• Ovarian epithelial cancer

• Fallopian tube cancer

• Primary peritoneal carcinoma

• Recurrent or persistent disease

• Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease

• Initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, or extended therapy administered after a surgical or nonsurgical assessment

• Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel

• Platinum-resistant or refractory disease, defined by 1 of the following:

• Treatment-free interval of < 6 months after completion of platinum-based therapy

• Persistent disease at completion of primary platinum-based therapy

• Progressive disease during platinum-based therapy

• Paclitaxel-resistant disease, defined as having had a treatment-free interval < 6 months or shown disease progression during paclitaxel-based therapy

• Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

• Must have ≥ 1 target lesion that can be used to assess response

• Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or biopsy confirms persistence ≥ 90 days after completion of radiotherapy

• Not a candidate for a higher priority GOG protocol

• GOG performance status 0-2

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9.0 g/dL

• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Bilirubin normal

• SGOT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• No active infection requiring antibiotics

• No sensory or motor neuropathy > grade 1

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• PT INR ≤ 1.5 or in-range INR 2-3 (if patient is on a stable dose of therapeutic warfarin)

• PTT < 1.2 times control

• No concurrent serious medical or psychiatric illness, including serious active infection

• No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)

• No uncompensated congestive heart failure or symptomatic coronary artery disease

• No myocardial infarction within the past 6 months

• No active bleeding

• No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer

• No history of allergic reactions attributed to chemical or biological composition to paclitaxel or other study agents

• No concurrent amifostine or other protective reagents

• Recovered from prior surgery, radiotherapy, or chemotherapy

• No prior paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®)

• No prior cancer treatment that would preclude study therapy

• No additional prior cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens

• One additional prior noncytotoxic regimen (i.e., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for management of recurrent or persistent disease allowed

• At least 1 week since prior hormonal therapy directed at the malignant tumor

• Concurrent hormone replacement therapy allowed

• At least 3 weeks since other prior therapy directed at the malignant tumor, including biologic therapy, immunologic agents, or radiotherapy

• More than 5 years since prior chemotherapy for any other portion of the abdominal cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian tube cancer

• Prior adjuvant chemotherapy for localized breast cancer allowed provided it was completed > 3 years ago and patient remains free of recurrent or metastatic disease

• More than 5 years since prior radiotherapy to any other portion of the abdominal cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian tube cancer

• Prior radiotherapy for localized breast cancer, cancer of the head and neck, or skin cancer allowed provided it was completed > 3 years ago and patient remains free of recurrent or metastatic disease

• No prior radiotherapy to > 25% of marrow-bearing areas

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colorado Gynecologic Oncology Group	Aurora	Colorado	United States	80010
2	The Hospital of Central Connecticut	New Britain	Connecticut	United States	06050
3	Beebe Medical Center	Lewes	Delaware	United States	19958
4	Rush University Medical Center	Chicago	Illinois	United States	60612
5	Union Hospital of Cecil County	Elkton	Maryland	United States	21921
6	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
7	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
8	North Shore University Hospital	Manhasset	New York	United States	11030
9	North Shore-LIJ Health System CCOP	Manhasset	New York	United States	11030
10	University of North Carolina	Chapel Hill	North Carolina	United States	27599
11	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
12	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
13	Mount Carmel Health Center West	Columbus	Ohio	United States	43222
14	Cancer Care Associates-Midtown	Tulsa	Oklahoma	United States	74104
15	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
16	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18105
17	Women and Infants Hospital	Providence	Rhode Island	United States	02905
18	University of Texas Medical Branch at Galveston	Galveston	Texas	United States	77555-0565
19	Carilion Clinic Gynecological Oncology	Roanoke	Virginia	United States	24016
20	University of Washington Medical Center	Seattle	Washington	United States	98195

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Robert Coleman, Gynecologic Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00499252
• Other Study ID Numbers: GOG-0126R; NCI-2009-00575; ABRAXIS-ABX-005; CDR0000553208; GOG-0126R; GOG-0126R; U10CA027469
• First Posted: Jul 11, 2007
• Last Update Posted: Jan 11, 2018
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Carcinoma; Recurrence; Paclitaxel; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Recruitment Details	The study was activated on 6/4/2007 and closed to accrual on 1/29/2009.

Arm/Group Title	Abraxane®
Arm/Group Description	Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Period Title: Overall Study
STARTED	51
COMPLETED	39
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Abraxane®
Arm/Group Description	Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Overall Participants	47
Age, Customized (participants) [Number]
20-29 years	0 0%
30-39 years	1 2.1%
40-49 years	8 17%
50-59 years	16 34%
60-69 years	15 31.9%
70-79 years	7 14.9%
Sex: Female, Male (Count of Participants)
Female	47 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Tumor Response
Description	Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Time Frame	every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels

Outcome Measure Data

Analysis Population Description

Eligible and Treated Patients

Arm/Group Title	Abraxane®
Arm/Group Description	Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Measure Participants	47
Number (95% Confidence Interval) [Percentage of participants]	23.4 49.8%

2. Primary Outcome

Title	Frequency and Severity of Observed Adverse Effects
Time Frame	Every cycle during treatment and up to 5 years after completion of treatment

Outcome Measure Data

Analysis Population Description

Treated and Eligible patients

Arm/Group Title	Grade 0	Grade 1 (CTCAE v 3.0)	Grade 2 (CTCAE v 3.0)	Grade 3 (CTCAE v 3.0)
Arm/Group Description	Number of patients who did not experience the specified AE.	Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
Measure Participants	47	47	47	47
Leukopenia	20 42.6%	15 NaN	11 NaN	1 NaN
Thrombocytopenia	43 91.5%	4 NaN	0 NaN	0 NaN
Neutropenia	30 63.8%	5 NaN	6 NaN	6 NaN
Anemia	5 10.6%	19 NaN	20 NaN	3 NaN
Cardiac	45 95.7%	2 NaN	0 NaN	0 NaN
Constitutional	12 25.5%	20 NaN	15 NaN	0 NaN
Dermatologic	28 59.6%	10 NaN	9 NaN	0 NaN
Gastrointestinal	18 38.3%	19 NaN	8 NaN	2 NaN
Hemorrhage	45 95.7%	1 NaN	1 NaN	0 NaN
Lymphatics	41 87.2%	6 NaN	0 NaN	0 NaN
Metabolic	35 74.5%	8 NaN	2 NaN	2 NaN
Musculoskeletal	44 93.6%	2 NaN	1 NaN	0 NaN
Neurosensory	27 57.4%	14 NaN	5 NaN	1 NaN
Other neurological	42 89.4%	4 NaN	1 NaN	0 NaN
Ocular/Visual	45 95.7%	1 NaN	1 NaN	0 NaN
Pain	32 68.1%	10 NaN	3 NaN	2 NaN
Pulmonary	40 85.1%	3 NaN	4 NaN	0 NaN

3. Secondary Outcome

Title	Progression-free Survival
Description	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Time Frame	from study entry until disease progression, death or date of last contact.

Outcome Measure Data

Analysis Population Description

Eligible and Treated Patients

Arm/Group Title	Abraxane®
Arm/Group Description	Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Measure Participants	47
Median (95% Confidence Interval) [months]	4.5

4. Secondary Outcome

Title	Overall Survival
Time Frame	from entry into the study to death or the date of last contact.

Outcome Measure Data

Analysis Population Description

Eligible and Treated Patients

Arm/Group Title	Abraxane®
Arm/Group Description	Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Measure Participants	47
Median (95% Confidence Interval) [months]	17.4

Adverse Events

Time Frame	every cycle
Adverse Event Reporting Description	"Number of participants at risk" total includes eligible and treated patients.
Arm/Group Title	Abraxane®
Arm/Group Description	Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
All Cause Mortality
	Abraxane®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Abraxane®
	Affected / at Risk (%)	# Events
Total	11/47 (23.4%)
Gastrointestinal disorders
Ileus	2/47 (4.3%)
Obstruction, Gi - Small Bowel Nos	4/47 (8.5%)
Vomiting	1/47 (2.1%)
Dehydration	1/47 (2.1%)
General disorders
Pain: Extremity-Limb	1/47 (2.1%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	1/47 (2.1%)
Metabolism and nutrition disorders
Hypercalcemia	1/47 (2.1%)
Renal and urinary disorders
Obstruction, Gu - Ureter	1/47 (2.1%)
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	1/47 (2.1%)
Other (Not Including Serious) Adverse Events
	Abraxane®
	Affected / at Risk (%)	# Events
Total	47/47 (100%)
Blood and lymphatic system disorders
Neutrophils	17/47 (36.2%)
Platelets	4/47 (8.5%)
Leukocytes	28/47 (59.6%)
Hemoglobin	42/47 (89.4%)
Lymphedema-Related Fibrosis	1/47 (2.1%)
Edema: Trunk/Genital	2/47 (4.3%)
Edema: Limb	8/47 (17%)
Cardiac disorders
Palpitations	1/47 (2.1%)
Ventricular Arrhythmia - Tachycardia	1/47 (2.1%)
Hypertension	1/47 (2.1%)
Cardiac General - Other	1/47 (2.1%)
Hypotension	1/47 (2.1%)
Ear and labyrinth disorders
Tinnitus	1/47 (2.1%)
Endocrine disorders
Hot Flashes	3/47 (6.4%)
Eye disorders
Blurred Vision	3/47 (6.4%)
Gastrointestinal disorders
Fistula, Gi - Small Bowel Nos	1/47 (2.1%)
Esophagitis	1/47 (2.1%)
Heartburn	3/47 (6.4%)
Dental: Teeth	1/47 (2.1%)
Ascites	1/47 (2.1%)
Ileus	1/47 (2.1%)
Dysphagia	1/47 (2.1%)
Distention	3/47 (6.4%)
Taste Alteration	2/47 (4.3%)
Mucositis (Functional/Sympt) - Oral Cavity	2/47 (4.3%)
Obstruction, Gi - Small Bowel Nos	3/47 (6.4%)
Mucositis (Clinical Exam) - Oral Cavity	1/47 (2.1%)
Vomiting	14/47 (29.8%)
Anorexia	7/47 (14.9%)
Dehydration	2/47 (4.3%)
Constipation	12/47 (25.5%)
Nausea	21/47 (44.7%)
Diarrhea	12/47 (25.5%)
General disorders
Sweating	1/47 (2.1%)
Weight Gain	5/47 (10.6%)
Fever	2/47 (4.3%)
Weight Loss	2/47 (4.3%)
Rigors/Chills	1/47 (2.1%)
Fatigue	33/47 (70.2%)
Insomnia	2/47 (4.3%)
Pain - Other	1/47 (2.1%)
Pain: Pelvis	1/47 (2.1%)
Pain: Chest /Thorax Nos	2/47 (4.3%)
Pain: Head/Headache	6/47 (12.8%)
Pain: Extremity-Limb	4/47 (8.5%)
Pain: Buttock	1/47 (2.1%)
Pain: Back	5/47 (10.6%)
Pain: Joint	7/47 (14.9%)
Pain: Bone	1/47 (2.1%)
Pain: Pain Nos	1/47 (2.1%)
Pain: Stomach	1/47 (2.1%)
Pain: Rectum	1/47 (2.1%)
Pain: Abdominal Pain Nos	14/47 (29.8%)
Pain: Tumor	1/47 (2.1%)
Pain: Muscle	1/47 (2.1%)
Pain: Neuralgia	1/47 (2.1%)
Immune system disorders
Rhinitis	1/47 (2.1%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	1/47 (2.1%)
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums	1/47 (2.1%)
Inf Unknown Anc: Sinus	1/47 (2.1%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	4/47 (8.5%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus	1/47 (2.1%)
Inf Unknown Anc: Upper Airway Nos	1/47 (2.1%)
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	2/47 (4.3%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	2/47 (4.3%)
Metabolism and nutrition disorders
Ast	2/47 (4.3%)
Creatinine	2/47 (4.3%)
Hypoalbuminemia	2/47 (4.3%)
Alt	2/47 (4.3%)
Alkaline Phosphatase	2/47 (4.3%)
Bilirubin	2/47 (4.3%)
Hypophosphatemia	2/47 (4.3%)
Hyponatremia	4/47 (8.5%)
Hypertriglyceridemia	1/47 (2.1%)
Hypocalcemia	4/47 (8.5%)
Hyperkalemia	3/47 (6.4%)
Hyperglycemia	6/47 (12.8%)
Hypokalemia	4/47 (8.5%)
Hypercalcemia	2/47 (4.3%)
Hypomagnesemia	7/47 (14.9%)
Musculoskeletal and connective tissue disorders
Joint-Function	1/47 (2.1%)
Joint Effusion	1/47 (2.1%)
Arthritis	2/47 (4.3%)
Muscle Weakness - Whole Body/Generalized	1/47 (2.1%)
Muscle Weakness - Extremity-Lower	1/47 (2.1%)
Nervous system disorders
Syncope	1/47 (2.1%)
Mood Alteration - Depression	5/47 (10.6%)
Mood Alteration - Anxiety	5/47 (10.6%)
Ataxia	1/47 (2.1%)
Memory Impairment	1/47 (2.1%)
Dizziness	3/47 (6.4%)
Neuropathy-Sensory	24/47 (51.1%)
Neuropathy-Motor	3/47 (6.4%)
Renal and urinary disorders
Cystitis	1/47 (2.1%)
Incontinence, Urinary	1/47 (2.1%)
Urinary Frequency	1/47 (2.1%)
Reproductive system and breast disorders
Vaginitis	1/47 (2.1%)
Vaginal Discharge	1/47 (2.1%)
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other	3/47 (6.4%)
Nasal/Paranasal Reactions	3/47 (6.4%)
Pneumothorax	1/47 (2.1%)
Cough	8/47 (17%)
Pleural Effusion	2/47 (4.3%)
Dyspnea	11/47 (23.4%)
Skin and subcutaneous tissue disorders
Nail Changes	3/47 (6.4%)
Photosensitivity	1/47 (2.1%)
Hair Loss/Alopecia (Scalp Or Body)	19/47 (40.4%)
Bruising	1/47 (2.1%)
Rash	7/47 (14.9%)
Dry Skin	1/47 (2.1%)
Pruritus	1/47 (2.1%)
Vascular disorders
Hemorrhage, Gi - Rectum	1/47 (2.1%)
Hemorrhage/Pulmonary - Nose	3/47 (6.4%)
Hematoma	1/47 (2.1%)
Petechiae	1/47 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

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.