Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00095979
• Collaborator: Gynecologic Oncology Group (Other)
• Enrollment: 52
• Location: 1
• Arm: 1
• Duration (Months): 50
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Adenocarcinoma; Recurrent Endometrial Carcinoma; Stage IV Endometrial Carcinoma	Drug: ixabepilone	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone.

2. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 2.5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (ixabepilone) Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: ixabepilone; Given IV; Other Names: BMS-247550 epothilone B lactam Ixempra

Outcome Measures

Primary Outcome Measures

1. Tumor Response [Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease]

   RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

2. Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) [Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)]

Secondary Outcome Measures

1. Progression-free Survival [From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.]

   Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

2. Overall Survival [From study entry to death or last contact, up to 5 years of follow-up.]

   Overall survival is defined as the duration of time from study entry to time of 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 endometrial adenocarcinoma

• Recurrent or persistent disease

• Histologic confirmation of the original primary tumor is required

• Not amenable to management with any of the following:

• Surgery

• Radiotherapy

• Higher priority or standard chemotherapy

• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan

• At least 1 target lesion

• Tumors within a previously irradiated field are designated as non-target lesions

• Disease in an irradiated field as the only site of measurable disease is acceptable as a target lesion only if there has been clear progression of the lesion at least 90 days after completion of radiotherapy

• Received 1, and only 1, prior chemotherapy regimen (e.g., high-dose therapy, consolidation, or extended therapy administered after surgery or non-surgical assessment) for management of endometrial adenocarcinoma

• Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (e.g., any active GOG phase III study for the same patient population)

• Performance status - GOG 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

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

• AST (aspartate aminotransferase) ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• Creatinine ≤ 1.5 times ULN

• Sensory or motor neuropathy ≤ grade 1

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection requiring antibiotics

• No other invasive malignancies within the past 5 years except non-melanoma skin cancer

• At least 3 weeks since prior biologic or immunologic agents directed at the malignant tumor

• One prior non-cytotoxic* (biologic or cytostatic) regimen for management of recurrent or persistent disease allowed

• See Disease Characteristics

• Prior paclitaxel or docetaxel allowed

• Recovered from prior chemotherapy

• No more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug therapy)

• No prior ixabepilone

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

• Continuation of hormone replacement therapy allowed

• See Disease Characteristics

• Recovered from prior radiotherapy

• Recovered from prior surgery

• At least 3 weeks since other prior therapy directed at the malignant tumor

• No prior cancer treatment that contraindicates study therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecologic Oncology Group	Philadelphia	Pennsylvania	United States	19103

Sponsors and Collaborators

• National Cancer Institute (NCI)
• Gynecologic Oncology Group

Investigators

• Principal Investigator: Don Dizon, Gynecologic Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00095979
• Other Study ID Numbers: NCI-2012-02628; NCI-2012-02628; CDR0000391849; GOG-0129P; GOG-0129P; U10CA027469
• First Posted: Nov 9, 2004
• Last Update Posted: Jul 24, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Carcinoma; Endometrial Neoplasms; Recurrence; Epothilones; Epothilone B

Study Results

Participant Flow

Recruitment Details	The study was activated on 5/2/2005 and closed to accrual on 1/3/2008 (suspended from 4/3/2006 to 4/1/2007).

Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Period Title: Overall Study
STARTED	52
COMPLETED	50
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.8 (9.4)
Age, Customized (participants) [Number]
20-29 years	0 0%
30-39 years	0 0%
40-49 years	2 4%
50-59 years	11 22%
60-69 years	19 38%
70-79 years	16 32%
80-89 years	2 4%
Sex: Female, Male (Count of Participants)
Female	50 100%
Male	0 0%
International Federation of Gynecology and Obstetrics (FIGO) Stage Recurrent/Persistent (participants) [Number]
Number [participants]	50 100%
Histologic Type (participants) [Number]
Adenocarcinoma, Unspecified	1 2%
Clear Cell Carcinoma	1 2%
Endometrioid Adenocarcinoma	22 44%
Mixed Epithelial Carcinoma	4 8%
Serous Adenocarcinoma	21 42%
Carcinosarcoma-homologous	1 2%

Outcome Measures

1. Primary Outcome

Title	Tumor Response
Description	RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time Frame	Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease

Outcome Measure Data

Analysis Population Description

Eligible and Treated Patients

Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Measure Participants	50
Number (90% Confidence Interval) [percentage of participants]	12 24%

2. Primary Outcome

Title	Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Time Frame	Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
Arm/Group Description	Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).	Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).	Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).	Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).	Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
Measure Participants	50	50	50	50	50
Leukopenia	9 18%	14 NaN	17 NaN	7 NaN	0 NaN
Neutropenia	5 10%	7 NaN	14 NaN	12 NaN	0 NaN
Anemia	12 24%	29 NaN	6 NaN	1 NaN	0 NaN
Thrombocytopenia	13 26%	4 NaN	1 NaN	1 NaN	0 NaN
Allergy/Immunology	4 8%	0 NaN	0 NaN	0 NaN	0 NaN
Auditory/ear	0 0%	2 NaN	0 NaN	0 NaN	0 NaN
Cardiac	1 2%	0 NaN	2 NaN	0 NaN	0 NaN
Coagulation	0 0%	0 NaN	1 NaN	0 NaN	0 NaN
Constitutional	15 30%	14 NaN	9 NaN	1 NaN	0 NaN
Dermatologic	7 14%	21 NaN	2 NaN	0 NaN	0 NaN
Gastrointestinal	11 22%	15 NaN	12 NaN	0 NaN	0 NaN
Genitourinary	1 2%	1 NaN	0 NaN	0 NaN	0 NaN
Hemorrhage	1 2%	1 NaN	2 NaN	0 NaN	0 NaN
Infection	0 0%	2 NaN	8 NaN	0 NaN	0 NaN
Lymphatics	8 16%	2 NaN	0 NaN	0 NaN	0 NaN
Metabolic	9 18%	8 NaN	3 NaN	1 NaN	0 NaN
Musculoskeletal	3 6%	4 NaN	0 NaN	0 NaN	0 NaN
Neurosensory	19 38%	7 NaN	4 NaN	0 NaN	0 NaN
Other neurologic	4 8%	3 NaN	4 NaN	1 NaN	0 NaN
Ocular/visual	3 6%	3 NaN	0 NaN	0 NaN	0 NaN
Pain	9 18%	8 NaN	3 NaN	0 NaN	0 NaN
Pulmonary	10 20%	4 NaN	2 NaN	0 NaN	1 NaN
Alopecia	7 14%	23 NaN	0 NaN	0 NaN	0 NaN
Vascular	0 0%	1 NaN	0 NaN	1 NaN	0 NaN

3. Secondary Outcome

Title	Progression-free Survival
Description	Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time Frame	From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.

Outcome Measure Data

Analysis Population Description

Eligible and Treated Patients

Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Measure Participants	50
Median (95% Confidence Interval) [months]	3.1

4. Secondary Outcome

Title	Overall Survival
Description	Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time Frame	From study entry to death or last contact, up to 5 years of follow-up.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Measure Participants	50
Median (95% Confidence Interval) [months]	8.8

Adverse Events

Time Frame	All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
All Cause Mortality
	Ixabepilone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ixabepilone
	Affected / at Risk (%)	# Events
Total	25/50 (50%)
Blood and lymphatic system disorders
Neutrophils	4/50 (8%)
Hemoglobin	1/50 (2%)
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation	1/50 (2%)
Gastrointestinal disorders
Vomiting	1/50 (2%)
Anorexia	1/50 (2%)
Nausea	3/50 (6%)
General disorders
Fatigue	1/50 (2%)
Death No Ctcae Term - Disease Progression Nos	1/50 (2%)
Pain: Abdominal Pain Nos	2/50 (4%)
Pain: Tumor	1/50 (2%)
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood	1/50 (2%)
Febrile Neutropenia	2/50 (4%)
Metabolism and nutrition disorders
Creatinine	1/50 (2%)
Hypoalbuminemia	1/50 (2%)
Hyponatremia	1/50 (2%)
Nervous system disorders
Syncope	2/50 (4%)
Mood Alteration - Depression	1/50 (2%)
Memory Impairment	1/50 (2%)
Dizziness	1/50 (2%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/50 (2%)
Vascular disorders
Thrombosis/Thrombus/Embolism	2/50 (4%)
Other (Not Including Serious) Adverse Events
	Ixabepilone
	Affected / at Risk (%)	# Events
Total	50/50 (100%)
Blood and lymphatic system disorders
Neutrophils	36/50 (72%)
Platelets	20/50 (40%)
Leukocytes	47/50 (94%)
Lymphopenia	1/50 (2%)
Hemoglobin	48/50 (96%)
Edema: Limb	12/50 (24%)
Cardiac disorders
Supraventricular Tachycardia	1/50 (2%)
Ventricular Arrhythmia - Pvcs	1/50 (2%)
Hypertension	2/50 (4%)
Hypotension	3/50 (6%)
Ear and labyrinth disorders
Hearing (Without Monitoring Program)	1/50 (2%)
Tinnitus	2/50 (4%)
Endocrine disorders
Hot Flashes	1/50 (2%)
Diabetes	1/50 (2%)
Hypoparathyroidism	1/50 (2%)
Hyperthyroidism	1/50 (2%)
Hypothyroidism	1/50 (2%)
Eye disorders
Ocular/Visual - Other	2/50 (4%)
Uveitis	1/50 (2%)
Watery Eye	2/50 (4%)
Dry Eye	1/50 (2%)
Flashing Lights/Floaters	1/50 (2%)
Blurred Vision	5/50 (10%)
Eyelid Dysfunction	1/50 (2%)
Gastrointestinal disorders
Esophagitis	1/50 (2%)
Heartburn	1/50 (2%)
Ascites	1/50 (2%)
Leak, Gi - Rectum	1/50 (2%)
Ileus	1/50 (2%)
Dysphagia	2/50 (4%)
Taste Alteration	6/50 (12%)
Dry Mouth	1/50 (2%)
Mucositis (Functional/Sympt) - Oral Cavity	4/50 (8%)
Obstruction, Gi - Small Bowel Nos	1/50 (2%)
Mucositis (Clinical Exam) - Oral Cavity	6/50 (12%)
Mucositis (Clinical Exam) - Esophagus	1/50 (2%)
Vomiting	19/50 (38%)
Anorexia	25/50 (50%)
Dehydration	4/50 (8%)
Constipation	24/50 (48%)
Nausea	22/50 (44%)
Diarrhea	22/50 (44%)
General disorders
Sweating	3/50 (6%)
Patient Odor	1/50 (2%)
Fever	5/50 (10%)
Weight Loss	4/50 (8%)
Rigors/Chills	4/50 (8%)
Fatigue	40/50 (80%)
Insomnia	7/50 (14%)
Pain: Pelvis	2/50 (4%)
Pain: Breast	1/50 (2%)
Pain: Vagina	1/50 (2%)
Pain: Chest /Thorax Nos	3/50 (6%)
Pain: Chest Wall	1/50 (2%)
Pain: Eye	1/50 (2%)
Pain: Head/Headache	7/50 (14%)
Pain: Extremity-Limb	11/50 (22%)
Pain: Back	8/50 (16%)
Pain: Joint	6/50 (12%)
Pain: Bone	3/50 (6%)
Pain: Kidney	1/50 (2%)
Pain: Bladder	2/50 (4%)
Pain: Pain Nos	2/50 (4%)
Pain: Stomach	2/50 (4%)
Pain: Oral Cavity	1/50 (2%)
Pain: Abdominal Pain Nos	14/50 (28%)
Pain: Middle Ear	1/50 (2%)
Pain: Tumor	1/50 (2%)
Pain: Muscle	8/50 (16%)
Pain: Neuralgia	2/50 (4%)
Immune system disorders
Allergic Reaction/Hypersensitivity	2/50 (4%)
Rhinitis	4/50 (8%)
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood	1/50 (2%)
Inf W/Gr 3 Or 4 Anc: Middle Ear	1/50 (2%)
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	1/50 (2%)
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums	1/50 (2%)
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related	1/50 (2%)
Febrile Neutropenia	3/50 (6%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	1/50 (2%)
Infection - Other	1/50 (2%)
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva	1/50 (2%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus	1/50 (2%)
Inf Unknown Anc: Urinary Tract Nos	7/50 (14%)
Inf Unknown Anc: Bladder (Urinary)	1/50 (2%)
Inf Unknown Anc: Lip/Perioral	1/50 (2%)
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos	1/50 (2%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	2/50 (4%)
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos	4/50 (8%)
Metabolism and nutrition disorders
Ast	4/50 (8%)
Gfr	1/50 (2%)
Proteinuria	3/50 (6%)
Hemoglobinuria	1/50 (2%)
Creatinine	10/50 (20%)
Hypoalbuminemia	10/50 (20%)
Alt	1/50 (2%)
Alkaline Phosphatase	4/50 (8%)
Bilirubin	3/50 (6%)
Hyponatremia	13/50 (26%)
Hypernatremia	1/50 (2%)
Hypocalcemia	9/50 (18%)
Hyperkalemia	2/50 (4%)
Hyperglycemia	14/50 (28%)
Hypokalemia	12/50 (24%)
Hypoglycemia	2/50 (4%)
Hypomagnesemia	15/50 (30%)
Musculoskeletal and connective tissue disorders
Joint-Function	1/50 (2%)
Arthritis	1/50 (2%)
Muscle Weakness - Whole Body/Generalized	3/50 (6%)
Muscle Weakness - Left-Sided	1/50 (2%)
Muscle Weakness - Extremity-Lower	2/50 (4%)
Nervous system disorders
Mood Alteration - Depression	5/50 (10%)
Mood Alteration - Anxiety	1/50 (2%)
Ataxia	1/50 (2%)
Confusion	1/50 (2%)
Memory Impairment	2/50 (4%)
Dizziness	6/50 (12%)
Neuropathy-Sensory	32/50 (64%)
Neuropathy-Motor	5/50 (10%)
Renal and urinary disorders
Leak, Gu - Vagina	1/50 (2%)
Cystitis	1/50 (2%)
Urinary Retention	1/50 (2%)
Obstruction, Gu - Ureter	1/50 (2%)
Incontinence, Urinary	4/50 (8%)
Bladder Spasm	1/50 (2%)
Urinary Frequency	2/50 (4%)
Reproductive system and breast disorders
Vaginal Discharge	1/50 (2%)
Respiratory, thoracic and mediastinal disorders
Voice Changes	1/50 (2%)
Hypoxia	2/50 (4%)
Hiccoughs	2/50 (4%)
Cough	11/50 (22%)
Pneumonitis	2/50 (4%)
Pleural Effusion	2/50 (4%)
Dyspnea	17/50 (34%)
Skin and subcutaneous tissue disorders
Nail Changes	6/50 (12%)
Hair Loss/Alopecia (Scalp Or Body)	30/50 (60%)
Bruising	1/50 (2%)
Rash	8/50 (16%)
Dry Skin	3/50 (6%)
Pruritus	3/50 (6%)
Flushing	1/50 (2%)
Hyperpigmentation	1/50 (2%)
Ulceration	1/50 (2%)
Vascular disorders
Inr	1/50 (2%)
Hemorrhage, Gu - Urinary Nos	2/50 (4%)
Hemorrhage, Gu - Vagina	4/50 (8%)
Hemorrhage, Gi - Rectum	2/50 (4%)
Hemorrhage, Gi - Upper Gi Nos	1/50 (2%)
Hemorrhage/Pulmonary - Nose	2/50 (4%)
Hemorrhage, Gu - Bladder	1/50 (2%)
Thrombosis/Thrombus/Embolism	5/50 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.