Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT01168232
• Collaborator: NRG Oncology (Other)
• Enrollment: 42
• Locations: 78
• Arm: 1
• Actual Duration (Months): 38.6
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This phase II trial is studying the side effects and how well ixabepilone works in treating patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Uterine Corpus Sarcoma; Uterine Carcinosarcoma	Drug: Ixabepilone; Other: Laboratory Biomarker Analysis	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To determine the response rate of ixabepilone in patients with persistent or recurrent carcinosarcoma of the uterus.

2. To determine the nature and degree of toxicity of ixabepilone in this cohort of patients.

SECONDARY OBJECTIVES:

1. To determine the duration of progression-free survival and overall survival.

TERTIARY OBJECTIVES:

1. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus.

2. To explore the association between class III beta-tubulin expression in carcinosarcoma of the uterus and response, progression-free and overall survival.

OUTLINE:

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
• Actual Study Start Date: Sep 7, 2010
• Actual Primary Completion Date: Nov 26, 2013
• Actual Study Completion Date: Nov 26, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (ixabepilone) Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: Ixabepilone; Given IV; Other Names: (1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione Azaepothilone B BMS 247550 BMS-247550 BMS247550 Epothilone Epothilone-B BMS 247550 Ixempra ; Other: Laboratory Biomarker Analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. Objective Tumor Response [Every other cycle for first 6 months; then every 3 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.1 cycle is 21 days]

   Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.

2. Adverse Events (Grade 3 or Higher) During Treatment Period. [During treatment and up to 30 days after stopping the study treatment]

   Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0

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-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1

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

Inclusion Criteria:

• Patients must have histologically confirmed uterine carcinosarcoma which is persistent or recurrent with documented disease progression after appropriate local therapy; acceptable histologic type is defined as carcinosarcoma (malignant mixed muellerian tumor), homologous or heterologous type

• All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria In Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI

• Patients must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy

• Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III or Rare Tumor protocol for the same patient population

• Patients must have a GOG Performance Status of 0, 1, or 2

• Recovery from effects of recent surgery, radiotherapy, or chemotherapy

• Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])

• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration

• Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration

• Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen

• Patients who have NOT received prior therapy with a taxane (such as paclitaxel or docetaxel) MUST receive a second regimen that includes a taxane

• Patients must have NOT received any additional cytotoxic chemotherapy except as noted above

• Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:

• Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction

• Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

• Platelets greater than or equal to 100,000/mcl

• Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)

• Bilirubin less than or equal to 1.5 x ULN

• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) less than or equal to 3 x ULN

• Alkaline phosphatase less than or equal to 2.5 x ULN

• Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

• Neuropathy (sensory and motor) less than or equal to grade 1

• Patients who have met the pre-entry requirements

• Patients of childbearing potential must have a negative serum pregnancy test 72 hours prior to the study entry and be practicing an effective form of contraception

• Patients who have received prior therapy with Ixabepilone

• Patients with a known history of severe (Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) grade 3 or 4 hypersensitivity reaction to agents containing Cremophor? EL or its derivatives (eg, polyoxyethylated castor oil)

• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease

• Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease

• Patients who are pregnant or nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	John Muir Medical Center-Concord Campus	Concord	California	United States	94520
3	John Muir Medical Center-Walnut Creek	Walnut Creek	California	United States	94598
4	University of Colorado Hospital	Aurora	Colorado	United States	80045
5	Hartford Hospital	Hartford	Connecticut	United States	06102
6	Smilow Cancer Hospital Care Center at Saint Francis	Hartford	Connecticut	United States	06105
7	The Hospital of Central Connecticut	New Britain	Connecticut	United States	06050
8	Florida Hospital Orlando	Orlando	Florida	United States	32803
9	Memorial University Medical Center	Savannah	Georgia	United States	31404
10	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	United States	83706
11	Rush University Medical Center	Chicago	Illinois	United States	60612
12	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
13	Sudarshan K Sharma MD Limted-Gynecologic Oncology	Hinsdale	Illinois	United States	60521
14	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
15	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois	United States	60555
16	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
17	Saint Vincent Hospital and Health Care Center	Indianapolis	Indiana	United States	46260
18	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa	United States	50325
19	Mercy Cancer Center-West Lakes	Clive	Iowa	United States	50325
20	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
21	Iowa-Wide Oncology Research Coalition NCORP	Des Moines	Iowa	United States	50309
22	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
23	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
24	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
25	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
26	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242
27	Methodist West Hospital	West Des Moines	Iowa	United States	50266-7700
28	Mercy Medical Center-West Lakes	West Des Moines	Iowa	United States	50266
29	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21215
30	Michigan Cancer Research Consortium NCORP	Ann Arbor	Michigan	United States	48106
31	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
32	Beaumont Hospital-Dearborn	Dearborn	Michigan	United States	48124
33	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
34	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
35	Hurley Medical Center	Flint	Michigan	United States	48503
36	Genesys Regional Medical Center-West Flint Campus	Flint	Michigan	United States	48532
37	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439
38	Allegiance Health	Jackson	Michigan	United States	49201
39	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
40	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
41	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
42	Sparrow Hospital	Lansing	Michigan	United States	48912
43	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
44	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
45	Lake Huron Medical Center	Port Huron	Michigan	United States	48060
46	Saint Mary's of Michigan	Saginaw	Michigan	United States	48601
47	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
48	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
49	Mercy Hospital Joplin	Joplin	Missouri	United States	64804
50	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
51	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri	United States	63109
52	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
53	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
54	Cancer Research for the Ozarks NCORP	Springfield	Missouri	United States	65804
55	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
56	CoxHealth South Hospital	Springfield	Missouri	United States	65807
57	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
58	Women's Cancer Center of Nevada	Las Vegas	Nevada	United States	89169
59	Cooper Hospital University Medical Center	Camden	New Jersey	United States	08103
60	State University of New York Downstate Medical Center	Brooklyn	New York	United States	11203
61	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
62	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	United States	28203
63	Duke University Medical Center	Durham	North Carolina	United States	27710
64	Summa Akron City Hospital/Cooper Cancer Center	Akron	Ohio	United States	44304
65	Case Western Reserve University	Cleveland	Ohio	United States	44106
66	Cleveland Clinic Cancer Center/Fairview Hospital	Cleveland	Ohio	United States	44111
67	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
68	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
69	Hillcrest Hospital Cancer Center	Mayfield Heights	Ohio	United States	44124
70	Lake University Ireland Cancer Center	Mentor	Ohio	United States	44060
71	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
72	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma	United States	74146
73	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
74	Women and Infants Hospital	Providence	Rhode Island	United States	02905
75	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
76	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
77	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
78	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• National Cancer Institute (NCI)
• NRG Oncology

Investigators

• Principal Investigator: Carolyn McCourt, NRG Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT01168232
• Other Study ID Numbers: NCI-2011-02056; NCI-2011-02056; GOG-0130F; CDR0000681684; GOG-0130F; GOG-0130F; U10CA180868; U10CA027469
• First Posted: Jul 23, 2010
• Last Update Posted: Aug 8, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Carcinosarcoma; Mixed Tumor, Mullerian; Recurrence; Epothilones; Epothilone B

Study Results

Participant Flow

Recruitment Details	The study was activated on 9/7/2010 and closed to accrual on 8/26/2013 (suspended from 3/5/2012 to 9/30/2012).

Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Period Title: Overall Study
STARTED	42
COMPLETED	34
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Overall Participants	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.9 (7.7)
Age, Customized (Count of Participants)
20-29 years	0 0%
30-39 years	0 0%
40-49 years	0 0%
50-59 years	7 20.6%
60-69 years	13 38.2%
70-79 years	12 35.3%
80-89 years	2 5.9%
Sex: Female, Male (Count of Participants)
Female	34 100%
Male	0 0%
International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent (participants) [Number]
Number [participants]	34 100%
Histologic Type (participants) [Number]
Carcinosarcoma-heterologus	17 50%
Carcinosarcoma-homologous	11 32.4%
Carcinosarcoma, MMT	6 17.6%

Outcome Measures

1. Primary Outcome

Title	Objective Tumor Response
Description	Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.
Time Frame	Every other cycle for first 6 months; then every 3 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.1 cycle is 21 days

Outcome Measure Data

Analysis Population Description

Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval

Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Measure Participants	34
Number (95% Confidence Interval) [percentage]	11.8

2. Primary Outcome

Title	Adverse Events (Grade 3 or Higher) During Treatment Period.
Description	Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0
Time Frame	During treatment and up to 30 days after stopping the study treatment

Outcome Measure Data

Analysis Population Description

Eligible and Treated Participants

Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Measure Participants	34
Leukopenia	15 44.1%
Thrombocytopenia	0 0%
Neutropenia	16 47.1%
Anemia	5 14.7%
Other Investigations	4 11.8%
Other Blood/lymphatics	2 5.9%
Cardiac Disorders	1 2.9%
Gastrointestinal disorders	6 17.6%
General disorders and administration site conditio	9 26.5%
Infections and infestations	3 8.8%
Metabolism and nutrition disorders	12 35.3%
Musculoskelatal and connective tissue disorders	1 2.9%
Neoplasms benign, malignant and unspecified	2 5.9%
Peripheral sensory neuropathy	1 2.9%
Other nervous system disorders	2 5.9%
Respitory, thoracic and mediastinal disorders	5 14.7%
Vascular disorders	8 23.5%

3. Secondary Outcome

Title	Progression-free Survival
Description	Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1
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 administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Measure Participants	34
Median (95% Confidence Interval) [months]	1.7

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 administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Measure Participants	34
Median (95% Confidence Interval) [months]	7.7

Adverse Events

Time Frame	All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
Arm/Group Title	Ixabepilone
Arm/Group Description	Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours 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	17/34 (50%)
Blood and lymphatic system disorders
Febrile Neutropenia	2/34 (5.9%)
Gastrointestinal disorders
Constipation	1/34 (2.9%)
Diarrhea	1/34 (2.9%)
General disorders
Death Nos	1/34 (2.9%)
Infections and infestations
Soft Tissue Infection	1/34 (2.9%)
Sepsis	1/34 (2.9%)
Investigations
Lymphocyte Count Decreased	2/34 (5.9%)
Neutrophil Count Decreased	2/34 (5.9%)
Metabolism and nutrition disorders
Dehydration	1/34 (2.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified	1/34 (2.9%)
Nervous system disorders
Headache	1/34 (2.9%)
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	1/34 (2.9%)
Pneumothorax	1/34 (2.9%)
Dyspnea	1/34 (2.9%)
Adult Respiratory Distress Syndrome	1/34 (2.9%)
Vascular disorders
Thromboembolic Event	1/34 (2.9%)
Hypotension	1/34 (2.9%)
Hypertension	1/34 (2.9%)
Other (Not Including Serious) Adverse Events
	Ixabepilone
	Affected / at Risk (%)	# Events
Total	34/34 (100%)
Blood and lymphatic system disorders
Anemia	33/34 (97.1%)
Cardiac disorders
Sinus Bradycardia	1/34 (2.9%)
Sinus Tachycardia	2/34 (5.9%)
Chest Pain - Cardiac	1/34 (2.9%)
Ear and labyrinth disorders
Tinnitus	3/34 (8.8%)
Hearing Impaired	4/34 (11.8%)
Eye disorders
Blurred Vision	3/34 (8.8%)
Gastrointestinal disorders
Dysphagia	2/34 (5.9%)
Dyspepsia	3/34 (8.8%)
Dry Mouth	1/34 (2.9%)
Constipation	15/34 (44.1%)
Diarrhea	12/34 (35.3%)
Vomiting	12/34 (35.3%)
Bloating	3/34 (8.8%)
Rectal Mucositis	1/34 (2.9%)
Abdominal Pain	9/34 (26.5%)
Rectal Hemorrhage	1/34 (2.9%)
Mucositis Oral	6/34 (17.6%)
Oral Pain	2/34 (5.9%)
Abdominal Distension	3/34 (8.8%)
Nausea	20/34 (58.8%)
Gastroesophageal Reflux Disease	1/34 (2.9%)
Ascites	2/34 (5.9%)
Flatulence	1/34 (2.9%)
General disorders
Pain	6/34 (17.6%)
Neck Edema	2/34 (5.9%)
Malaise	1/34 (2.9%)
Localized Edema	1/34 (2.9%)
Non-Cardiac Chest Pain	1/34 (2.9%)
Edema Limbs	4/34 (11.8%)
Edema Face	1/34 (2.9%)
Fatigue	24/34 (70.6%)
Fever	2/34 (5.9%)
Chills	1/34 (2.9%)
Infusion Related Reaction	1/34 (2.9%)
Immune system disorders
Allergic Reaction	1/34 (2.9%)
Infections and infestations
Skin Infection	1/34 (2.9%)
Sinusitis	1/34 (2.9%)
Nail Infection	1/34 (2.9%)
Urinary Tract Infection	3/34 (8.8%)
Injury, poisoning and procedural complications
Fall	1/34 (2.9%)
Bruising	1/34 (2.9%)
Investigations
Weight Loss	6/34 (17.6%)
Weight Gain	2/34 (5.9%)
Platelet Count Decreased	15/34 (44.1%)
Lymphocyte Count Decreased	4/34 (11.8%)
Inr Increased	1/34 (2.9%)
Fibrinogen Decreased	1/34 (2.9%)
Creatinine Increased	7/34 (20.6%)
Neutrophil Count Decreased	28/34 (82.4%)
White Blood Cell Decreased	29/34 (85.3%)
Aspartate Aminotransferase Increased	7/34 (20.6%)
Alkaline Phosphatase Increased	7/34 (20.6%)
Alanine Aminotransferase Increased	5/34 (14.7%)
Metabolism and nutrition disorders
Hypophosphatemia	2/34 (5.9%)
Hyponatremia	11/34 (32.4%)
Hypomagnesemia	5/34 (14.7%)
Hypokalemia	4/34 (11.8%)
Hypoglycemia	1/34 (2.9%)
Hypocalcemia	5/34 (14.7%)
Hypoalbuminemia	11/34 (32.4%)
Hypernatremia	1/34 (2.9%)
Hypermagnesemia	1/34 (2.9%)
Hyperkalemia	1/34 (2.9%)
Hyperglycemia	10/34 (29.4%)
Hypercalcemia	2/34 (5.9%)
Dehydration	5/34 (14.7%)
Anorexia	12/34 (35.3%)
Acidosis	1/34 (2.9%)
Musculoskeletal and connective tissue disorders
Pain In Extremity	5/34 (14.7%)
Neck Pain	1/34 (2.9%)
Myalgia	10/34 (29.4%)
Muscle Weakness Lower Limb	3/34 (8.8%)
Generalized Muscle Weakness	2/34 (5.9%)
Back Pain	2/34 (5.9%)
Arthralgia	7/34 (20.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl	1/34 (2.9%)
Nervous system disorders
Tremor	1/34 (2.9%)
Peripheral Sensory Neuropathy	19/34 (55.9%)
Peripheral Motor Neuropathy	1/34 (2.9%)
Paresthesia	1/34 (2.9%)
Headache	7/34 (20.6%)
Dysgeusia	2/34 (5.9%)
Syncope	1/34 (2.9%)
Dizziness	7/34 (20.6%)
Depressed Level Of Consciousness	1/34 (2.9%)
Concentration Impairment	1/34 (2.9%)
Cognitive Disturbance	1/34 (2.9%)
Psychiatric disorders
Insomnia	5/34 (14.7%)
Depression	3/34 (8.8%)
Anxiety	1/34 (2.9%)
Renal and urinary disorders
Urinary Retention	1/34 (2.9%)
Urinary Incontinence	1/34 (2.9%)
Urinary Tract Pain	3/34 (8.8%)
Urinary Frequency	4/34 (11.8%)
Hematuria	3/34 (8.8%)
Reproductive system and breast disorders
Vaginal Hemorrhage	4/34 (11.8%)
Pelvic Pain	1/34 (2.9%)
Vaginal Discharge	1/34 (2.9%)
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -	1/34 (2.9%)
Respiratory Failure	1/34 (2.9%)
Pneumothorax	1/34 (2.9%)
Pleural Effusion	2/34 (5.9%)
Productive Cough	1/34 (2.9%)
Hypoxia	1/34 (2.9%)
Dyspnea	14/34 (41.2%)
Cough	4/34 (11.8%)
Allergic Rhinitis	3/34 (8.8%)
Skin and subcutaneous tissue disorders
Pruritus	1/34 (2.9%)
Nail Ridging	1/34 (2.9%)
Nail Loss	2/34 (5.9%)
Nail Discoloration	2/34 (5.9%)
Dry Skin	1/34 (2.9%)
Alopecia	18/34 (52.9%)
Vascular disorders
Thromboembolic Event	2/34 (5.9%)
Hypotension	3/34 (8.8%)
Hypertension	7/34 (20.6%)

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.