Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00407758
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 28
• Locations: 16
• Patients Per Site: 1.8

Study Details

Study Description

Brief Summary

RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer; Primary Peritoneal Cavity Cancer	Drug: enzastaurin hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free survival or objective tumor response, in patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.

• Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

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

• Determine the effects of prognostic variables, including platinum sensitivity, initial performance status, and age, in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days 2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride once daily on days 1-28. Courses repeat 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.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Aug 1, 2016

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 [CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.]

   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.

2. Progression-free Survival > 6 Months Using RECIST 1.0 [CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.]

   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.

3. Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 [Assessed every cycle while on treatment, 30 days after the last cycle of treatment]

   Number of participants with a maximum grade of 3 or higher during the treatment period.

Secondary Outcome Measures

1. Duration Overall Survival [Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.]

   Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

2. Duration of Progression-free Survival (PFS) [CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.]

   Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. 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.

3. Prognostic Factor - Number of Patients With Platinum Sensitivity [Baseline]

   Platinum sensitive = a platinum-free interval between 6 and 12 months.

4. Prognostic Factor - Initial Performance Status [Baseline]

   Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work

5. Prognostic Factor - Age at Study Entry [Baseline]

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 or primary peritoneal carcinoma

• Recurrent or persistent disease

• 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 to assess response

• 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

• 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 high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment

• Must meet any 1 of the following criteria for platinum-based therapy:

• Disease progression during therapy

• Treatment-free interval after completion of treatment < 12 months

• Disease persistence after completion of therapy

• Ineligible for a higher priority GOG clinical trial

PATIENT CHARACTERISTICS:

• GOG performance status 0-1 (for patients who received 2 prior treatment regimens) OR 0-2 (for patients who received 1 prior treatment regimen)

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9 g/dL (transfusions allowed)

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

• Bilirubin ≤ 2 times ULN

• Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)

• AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• Able to swallow tablets

• No sensory or motor neuropathy > grade 1

• No active infection requiring antibiotics

• No other invasive malignancies or evidence of cancer within the past 5 years except nonmelanoma skin cancer

• No serious systemic disorders that would preclude study compliance, including an abnormal ECG indicative of cardiac disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior surgery, radiotherapy, or chemotherapy

• At least 1 week since prior anticancer hormonal therapy

• No more than 1 additional cytotoxic regimen for management of recurrent or persistent disease

• At least 4 weeks since other prior anticancer therapy, including immunotherapy

• At least 30 days since prior investigational drugs

• No prior enzastaurin hydrochloride

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

• No prior noncytotoxic therapy, including bevacizumab, for recurrent or persistent disease

• No prior treatment that would preclude treatment on this protocol

• No concurrent chemotherapy, immunotherapy, or other experimental medications

• No concurrent enzyme-inducing antiepileptic drugs, including carbamazepine, phenobarbital, or phenytoin

• No other concurrent systemic anticancer therapy

• No concurrent radiotherapy, including palliative radiotherapy

• No concurrent agents that stimulate thrombopoiesis

• No concurrent amifostine or other protective reagents

• Concurrent hormone replacement therapy allowed

• Concurrent bisphosphonates allowed provided bony metastases are present

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781
2	Rush University Medical Center	Chicago	Illinois	United States	60612
3	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
4	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois	United States	60201-1781
5	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
6	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
7	St. Vincent Indianapolis Hospital	Indianapolis	Indiana	United States	46260
8	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
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	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
12	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
13	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
14	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
15	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania	United States	19612-6052
16	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Lydia Usha, MD, Rush University Medical Center
• Study Chair: Jean A. Hurteau, MD, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00407758
• Other Study ID Numbers: GOG-0170J; CDR0000517318; LILLY-H6Q-MC-S025
• First Posted: Dec 5, 2006
• Last Update Posted: Mar 20, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Gynecologic Oncology Group: recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

Study Results

Participant Flow

Recruitment Details	This trial was opened to patient entry on November 6, 2006 and was closed to accrual on May 7, 2007.

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Period Title: Overall Study
STARTED	28
COMPLETED	27
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Participants	27
Age, Customized (Count of Participants)
40-49 years	4 14.8%
50-59 years	10 37%
60-69 years	6 22.2%
70-79 years	7 25.9%
Sex: Female, Male (Count of Participants)
Female	27 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 3.7%
White	26 96.3%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
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.
Time Frame	CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Measure Participants	27
Partial response	2 7.4%
Complete response	0 0%

2. Primary Outcome

Title	Progression-free Survival > 6 Months Using RECIST 1.0
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	CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Measure Participants	27
PFS> 6 months - Yes	3 11.1%
PFS>6months - No	24 88.9%

3. Primary Outcome

Title	Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Description	Number of participants with a maximum grade of 3 or higher during the treatment period.
Time Frame	Assessed every cycle while on treatment, 30 days after the last cycle of treatment

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Measure Participants	27
Anemia	1 3.7%
Constitutional	5 18.5%
Gastrointestinal	11 40.7%
Infection	2 7.4%
Metabolic	4 14.8%
Other Neurological	1 3.7%
Pain	5 18.5%
Pulmonary	5 18.5%
Vascular	1 3.7%
Death, not CTC coded	3 11.1%

4. Secondary Outcome

Title	Duration 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	Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Measure Participants	27
Median (90% Confidence Interval) [months]	15.1

5. Secondary Outcome

Title	Duration of Progression-free Survival (PFS)
Description	Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. 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	CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Measure Participants	27
Median (90% Confidence Interval) [months]	1.8

6. Secondary Outcome

Title	Prognostic Factor - Number of Patients With Platinum Sensitivity
Description	Platinum sensitive = a platinum-free interval between 6 and 12 months.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Measure Participants	27
Platinum Sensitive	11 40.7%
Not Platinum Sensitive	16 59.3%

7. Secondary Outcome

Title	Prognostic Factor - Initial Performance Status
Description	Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Measure Participants	27
Performance Status = 0	16 59.3%
Performance Status = 1	11 40.7%

8. Secondary Outcome

Title	Prognostic Factor - Age at Study Entry
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Measure Participants	27
Median (Inter-Quartile Range) [years]	59

Adverse Events

Time Frame	Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Arm/Group Title	Enzastaurin
Arm/Group Description	Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
All Cause Mortality
	Enzastaurin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Enzastaurin
	Affected / at Risk (%)	# Events
Total	12/27 (44.4%)
Gastrointestinal disorders
Obstruction, Gi - Rectum	1/27 (3.7%)
Obstruction, Gi - Colon	1/27 (3.7%)
Ascites	1/27 (3.7%)
Dehydration	1/27 (3.7%)
Constipation	1/27 (3.7%)
General disorders
Death No Ctcae Term - Disease Progression Nos	3/27 (11.1%)
Pain: Abdominal Pain Nos	2/27 (7.4%)
Metabolism and nutrition disorders
Hyperkalemia	1/27 (3.7%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/27 (3.7%)
Aspiration	1/27 (3.7%)
Dyspnea	1/27 (3.7%)
Vascular disorders
Thrombosis/Thrombus/Embolism	1/27 (3.7%)
Other (Not Including Serious) Adverse Events
	Enzastaurin
	Affected / at Risk (%)	# Events
Total	27/27 (100%)
Blood and lymphatic system disorders
Neutrophils	1/27 (3.7%)
Platelets	3/27 (11.1%)
Leukocytes	3/27 (11.1%)
Lymphopenia	1/27 (3.7%)
Hemoglobin	19/27 (70.4%)
Edema: Limb	8/27 (29.6%)
Edema: Head And Neck	1/27 (3.7%)
Cardiac disorders
Palpitations	1/27 (3.7%)
Hypertension	2/27 (7.4%)
Endocrine disorders
Hot Flashes	2/27 (7.4%)
Diabetes	1/27 (3.7%)
Gastrointestinal disorders
Obstruction, Gi - Colon	1/27 (3.7%)
Heartburn	2/27 (7.4%)
Ascites	4/27 (14.8%)
Ileus	1/27 (3.7%)
Dysphagia	1/27 (3.7%)
Distention	3/27 (11.1%)
Taste Alteration	2/27 (7.4%)
Incontinence, Anal	1/27 (3.7%)
Dry Mouth	3/27 (11.1%)
Obstruction, Gi - Small Bowel Nos	2/27 (7.4%)
Vomiting	9/27 (33.3%)
Anorexia	12/27 (44.4%)
Dehydration	1/27 (3.7%)
Constipation	12/27 (44.4%)
Nausea	11/27 (40.7%)
Gastrointestinal - Other	1/27 (3.7%)
Diarrhea	13/27 (48.1%)
General disorders
Sweating	2/27 (7.4%)
Weight Gain	1/27 (3.7%)
Fever	1/27 (3.7%)
Weight Loss	1/27 (3.7%)
Fatigue	20/27 (74.1%)
Insomnia	4/27 (14.8%)
Pain: Pelvis	1/27 (3.7%)
Pain: Breast	1/27 (3.7%)
Pain: Chest /Thorax Nos	1/27 (3.7%)
Pain: Head/Headache	3/27 (11.1%)
Pain: Extremity-Limb	1/27 (3.7%)
Pain: Joint	3/27 (11.1%)
Pain: Bone	1/27 (3.7%)
Pain: Rectum	1/27 (3.7%)
Pain: Abdominal Pain Nos	11/27 (40.7%)
Pain: Tumor	1/27 (3.7%)
Pain: Muscle	3/27 (11.1%)
Flu-Like Syndrome	1/27 (3.7%)
Immune system disorders
Rhinitis	4/27 (14.8%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	1/27 (3.7%)
Inf W/Nml Or Gr 1 Or 2 Anc: Pleura	1/27 (3.7%)
Inf W/Nml Or Gr 1 Or 2 Anc: Blood	1/27 (3.7%)
Inf W/Nml Or Gr 1 Or 2 Anc: Wound	1/27 (3.7%)
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	1/27 (3.7%)
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related	1/27 (3.7%)
Inf W/Nml Or Gr 1 Or 2 Anc: Colon	1/27 (3.7%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	5/27 (18.5%)
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina	1/27 (3.7%)
Inf W/Gr 3 Or 4 Anc: Vulva	1/27 (3.7%)
Metabolism and nutrition disorders
Ast	2/27 (7.4%)
Gfr	3/27 (11.1%)
Creatinine	4/27 (14.8%)
Hypoalbuminemia	5/27 (18.5%)
Alt	1/27 (3.7%)
Alkaline Phosphatase	3/27 (11.1%)
Hypophosphatemia	2/27 (7.4%)
Hyponatremia	6/27 (22.2%)
Hypertriglyceridemia	1/27 (3.7%)
Hypernatremia	1/27 (3.7%)
Hypocalcemia	3/27 (11.1%)
Hyperkalemia	3/27 (11.1%)
Hyperglycemia	4/27 (14.8%)
Hypokalemia	3/27 (11.1%)
Hypoglycemia	1/27 (3.7%)
Hypomagnesemia	4/27 (14.8%)
Nervous system disorders
Mood Alteration - Depression	2/27 (7.4%)
Mood Alteration - Anxiety	2/27 (7.4%)
Tremor	1/27 (3.7%)
Somnolence	1/27 (3.7%)
Dizziness	2/27 (7.4%)
Neuropathy-Sensory	1/27 (3.7%)
Neuropathy-Motor	1/27 (3.7%)
Renal and urinary disorders
Renal/Genitourinary - Other	1/27 (3.7%)
Urinary Color Change	3/27 (11.1%)
Reproductive system and breast disorders
Vaginal Dryness	1/27 (3.7%)
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other	1/27 (3.7%)
Cough	2/27 (7.4%)
Dyspnea	12/27 (44.4%)
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)	2/27 (7.4%)
Acne	1/27 (3.7%)
Rash	3/27 (11.1%)
Dry Skin	2/27 (7.4%)
Decubitus	1/27 (3.7%)
Ulceration	1/27 (3.7%)
Vascular disorders
Hemorrhage, Gu - Vagina	1/27 (3.7%)
Hemorrhage, Gi - Rectum	1/27 (3.7%)
Hemorrhage, Gi - Upper Gi Nos	1/27 (3.7%)
Hemorrhage/Pulmonary - Nose	1/27 (3.7%)
Petechiae	1/27 (3.7%)

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.