Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00459290
• Collaborator: (none)
• Enrollment: 24
• Locations: 22
• Arm: 1
• Duration (Months): 38
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Progesterone can cause the growth of ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer. Hormone therapy using mifepristone may fight ovarian epithelial cancer and primary peritoneal cancer by lowering the amount of progesterone the body makes.

PURPOSE: This phase II trial is studying the side effects and how well mifepristone works in treating patients with recurrent or persistent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer	Drug: mifepristone	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the antitumor activity of mifepristone in patients with recurrent or persistent ovarian epithelial, primary peritoneal, or fallopian tube carcinoma.

• Determine the toxicity of this drug in these patients.

Secondary

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

• Determine the potential impact of platinum sensitivity, initial performance status, and age on prognosis in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral mifepristone once daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mifepristone 200 mg PO daily Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks is considered one cycle) until disease progression or adverse effects prohibit further therapy.	Drug: mifepristone

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival at 6 Months [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.]

   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 is 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. Proportion of Patients With Objective 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 is 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.

3. Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [Every cycle, during treatment (average of 3 months).]

Secondary Outcome Measures

1. Progression-free Survival [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.]

   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 is 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 [Five years]

3. Progression-free Survival by Platinum Sensitivity [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.]

   Platinum Senstive defined as treatment free interval >6 months on most recent platinum

4. Progression-free Survival by Performance Status [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.]

5. Progression-free Survival by Age (y) [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.]

   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 is 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma*

• Recurrent or refractory disease NOTE: *Histological confirmation of original primary tumor required

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, and MRI OR ≥ 10 mm by spiral CT scan

• Must have ≥ 1 target lesion

• Tumors within a previously irradiated field are designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy

• Prior treatment with 1 platinum-based chemotherapeutic regimen (comprising carboplatin, cisplatin, or another organoplatinum compound) for management of primary disease required

• Initial treatment may have included any of the following:

• High-dose therapy

• Consolidation therapy

• Extended therapy administered after surgical or nonsurgical assessment

• Patients must meet ≥ 1 of the following criteria:

• Treatment-free interval after platinum therapy of < 12 months

• Progressed during platinum-based therapy

• Persistent disease after a platinum-based regimen

• Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists

PATIENT CHARACTERISTICS:

• GOG performance status 0-2

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

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

• Bilirubin ≤ 1.5 times ULN

• AST ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• No active infection requiring antibiotics

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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior surgery, radiotherapy, or chemotherapy

• No prior cancer treatment that would preclude protocol therapy

• No prior radiotherapy to any portion of the abdominal cavity or pelvis unless for treatment of ovarian cancer

• Prior radiotherapy for localized cancer of the breast, head and neck, or skin is permitted, provided it was completed > 3 years prior to study entry and no recurrent or metastatic disease exists

• No prior chemotherapy to any portion of the abdominal cavity or pelvis unless for treatment of ovarian cancer

• Prior chemotherapy for localized cancer of the breast is permitted, provided it was completed > 3 years prior to study entry and no recurrent or metastatic disease exists

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

• At least 2 weeks since other prior hormonal therapy (e.g., testosterone, estrogen, progestin, or gonadotropin-releasing hormone antagonists)

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

• One prior cytotoxic regimen (defined as any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa) for management of recurrent or persistent disease allowed

• No prior non-cytotoxic therapy for management of recurrent or persistent ovarian epithelial or primary peritoneal carcinoma

• No prior mifepristone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California	United States	90027
2	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
3	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut	United States	06050
4	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
5	Woman's Hospital	Baton Rouge	Louisiana	United States	70815
6	Maine Medical Center - Bramhall Campus	Portland	Maine	United States	04102
7	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi	United States	39581
8	Freeman Cancer Institute at Freeman Health System	Joplin	Missouri	United States	64804
9	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
10	Methodist Estabrook Cancer Center	Omaha	Nebraska	United States	68114
11	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
12	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
13	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
14	Lake/University Ireland Cancer Center	Mentor	Ohio	United States	44060
15	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
16	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
17	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
18	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
19	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
20	Women and Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
21	University of Texas Medical Branch	Galveston	Texas	United States	77555-0361
22	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449

Sponsors and Collaborators

• Gynecologic Oncology Group

Investigators

• Study Chair: Thomas F. Rocereto, MD, Cancer Institute of New Jersey at Cooper - Voorhees

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00459290
• Other Study ID Numbers: GOG-0170K
• First Posted: Apr 11, 2007
• Last Update Posted: Jul 18, 2018
• Last Verified: Jun 1, 2014

• Keywords provided by Gynecologic Oncology Group: recurrent ovarian epithelial cancer; primary peritoneal cavity cancer; fallopian tube cancer
• Additional relevant MeSH terms: Fallopian Tube Neoplasms; Mifepristone

Study Results

Participant Flow

Recruitment Details	The study was activated on 5/7/2007 and closed to accrual on 10/29/2007.

Arm/Group Title	Mifepristone
Arm/Group Description	Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Period Title: Overall Study
STARTED	24
COMPLETED	19
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Mifepristone
Arm/Group Description	Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Overall Participants	22
Age, Customized (participants) [Number]
40-49 years	1 4.5%
50-59 years	6 27.3%
60-69 years	8 36.4%
70-79 years	6 27.3%
80-89 years	1 4.5%
Sex: Female, Male (Count of Participants)
Female	22 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival at 6 Months
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 is 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 participants

Arm/Group Title	Mifepristone
Arm/Group Description	Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Measure Participants	22
Number (95% Confidence Interval) [percentage of participants]	13.6 61.8%

2. Primary Outcome

Title	Proportion of Patients With Objective 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 is 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 participants

Arm/Group Title	Mifepristone
Arm/Group Description	Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Measure Participants	22
Number (95% Confidence Interval) [percentage of participants]	4.5 20.5%

3. Primary Outcome

Title	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time Frame	Every cycle, during treatment (average of 3 months).

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Mifepristone
Arm/Group Description	Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Measure Participants	22
Anemia	1 4.5%
Coagulation	2 9.1%
Dermatologic	1 4.5%
Gastrointestinal	1 4.5%
Hemorrhage	1 4.5%

4. 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 is 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 participants

Arm/Group Title	Mifepristone
Arm/Group Description	Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Measure Participants	22
Median (95% Confidence Interval) [months]	1.8

5. Secondary Outcome

Title	Overall Survival
Time Frame	Five years

Outcome Measure Data

Analysis Population Description

Eligible and treated participants

Arm/Group Title	Mifepristone
Arm/Group Description	Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
Measure Participants	22
Median (95% Confidence Interval) [months]	NA

6. Secondary Outcome

Title	Progression-free Survival by Platinum Sensitivity
Description	Platinum Senstive defined as treatment free interval >6 months on most recent platinum
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 participants with treatment free interval available

Arm/Group Title	Not Platinum Sensitive	Platinum Sensitive
Arm/Group Description
Measure Participants	13	8
Median (95% Confidence Interval) [months]	1.7	1.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mifepristone, Platinum Sensitive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7912
	Comments
	Method	Log Rank
	Comments

7. Secondary Outcome

Title	Progression-free Survival by Performance Status
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 participants

Arm/Group Title	GOG Performance Status 0	GOG Performance Status 1
Arm/Group Description	Fully active, able to carry on all pre-disease performance without restriction.	Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
Measure Participants	13	9
Median (95% Confidence Interval) [months]	1.8	1.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mifepristone, Platinum Sensitive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1545
	Comments
	Method	Log Rank
	Comments

8. Secondary Outcome

Title	Progression-free Survival by Age (y)
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 is 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 participants

Arm/Group Title	< 60	60 <70	>=70
Arm/Group Description
Measure Participants	7	8	7
Median (95% Confidence Interval) [months]	1.7	4.0	1.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mifepristone, Platinum Sensitive, >=70
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0648
	Comments
	Method	Log Rank
	Comments

Adverse Events

Time Frame	every cycle during treatment
Arm/Group Title	Mifepristone
Arm/Group Description	Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
All Cause Mortality
	Mifepristone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Mifepristone
	Affected / at Risk (%)	# Events
Total	8/22 (36.4%)
Gastrointestinal disorders
Perforation, Gi - Colon	1/22 (4.5%)
Obstruction, Gi - Small Bowel Nos	2/22 (9.1%)
General disorders
Death No Ctcae Term - Disease Progression Nos	1/22 (4.5%)
Pain: Abdominal Pain Nos	1/22 (4.5%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis	1/22 (4.5%)
Dyspnea	2/22 (9.1%)
Other (Not Including Serious) Adverse Events
	Mifepristone
	Affected / at Risk (%)	# Events
Total	20/22 (90.9%)
Blood and lymphatic system disorders
Neutrophils	1/22 (4.5%)
Platelets	2/22 (9.1%)
Leukocytes	3/22 (13.6%)
Hemoglobin	7/22 (31.8%)
Endocrine disorders
Hot Flashes	4/22 (18.2%)
Eye disorders
Blurred Vision	2/22 (9.1%)
Gastrointestinal disorders
Flatulence	2/22 (9.1%)
Gastritis	1/22 (4.5%)
Heartburn	2/22 (9.1%)
Ascites	2/22 (9.1%)
Distention	1/22 (4.5%)
Obstruction, Gi - Small Bowel Nos	1/22 (4.5%)
Vomiting	6/22 (27.3%)
Anorexia	3/22 (13.6%)
Dehydration	3/22 (13.6%)
Constipation	5/22 (22.7%)
Nausea	12/22 (54.5%)
Diarrhea	3/22 (13.6%)
General disorders
Fatigue	9/22 (40.9%)
Pain: Pelvis	1/22 (4.5%)
Pain: Pleura	1/22 (4.5%)
Pain: Extremity-Limb	1/22 (4.5%)
Pain: Back	1/22 (4.5%)
Pain: Joint	1/22 (4.5%)
Pain: Bladder	1/22 (4.5%)
Pain: Abdominal Pain Nos	7/22 (31.8%)
Pain: Tumor	1/22 (4.5%)
Pain: Muscle	1/22 (4.5%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	3/22 (13.6%)
Inf Unknown Anc: Urinary Tract Nos	1/22 (4.5%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	1/22 (4.5%)
Metabolism and nutrition disorders
Ast	1/22 (4.5%)
Creatinine	2/22 (9.1%)
Hypoalbuminemia	3/22 (13.6%)
Bilirubin	1/22 (4.5%)
Hypophosphatemia	2/22 (9.1%)
Hyponatremia	1/22 (4.5%)
Hypocalcemia	3/22 (13.6%)
Hyperkalemia	1/22 (4.5%)
Hyperglycemia	4/22 (18.2%)
Hypokalemia	5/22 (22.7%)
Hypoglycemia	2/22 (9.1%)
Hypomagnesemia	2/22 (9.1%)
Musculoskeletal and connective tissue disorders
Arthritis	1/22 (4.5%)
Muscle Weakness - Whole Body/Generalized	1/22 (4.5%)
Muscle Weakness - Extremity-Lower	1/22 (4.5%)
Nervous system disorders
Mood Alteration - Depression	1/22 (4.5%)
Mood Alteration - Anxiety	1/22 (4.5%)
Irritability	1/22 (4.5%)
Neuropathy-Sensory	3/22 (13.6%)
Neuropathy-Motor	1/22 (4.5%)
Renal and urinary disorders
Urinary Frequency	2/22 (9.1%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/22 (4.5%)
Dyspnea	3/22 (13.6%)
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)	1/22 (4.5%)
Rash	2/22 (9.1%)
Pruritus	2/22 (9.1%)
Vascular disorders
Inr	2/22 (9.1%)
Hemorrhage, Gu - Urinary Nos	2/22 (9.1%)
Hemorrhage, Gi - Rectum	1/22 (4.5%)
Hemorrhage, Gu - Bladder	1/22 (4.5%)
Thrombosis/Thrombus/Embolism	1/22 (4.5%)

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.