Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01646762
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 35.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with multiple myeloma that has returned or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Condition or Disease	Intervention/Treatment	Phase
Refractory Plasma Cell Myeloma	Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Other: Laboratory Biomarker Analysis	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To evaluate the efficacy (overall response rate) of single agent nab-paclitaxel (Abraxane) (paclitaxel albumin-stabilized nanoparticle formulation) in patients with relapsed or refractory multiple myeloma.

SECONDARY OBJECTIVES:

1. To evaluate the adverse events associated with use of single agent nab-paclitaxel (Abraxane) in patients with relapsed or refractory multiple myeloma.

2. To evaluate overall survival, time to progression, and duration of response among patients with relapsed or refractory multiple myeloma undergoing treatment with single agent nab-paclitaxel (Abraxane).

OUTLINE:

Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for up to 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma
• Study Start Date: Nov 5, 2012
• Actual Primary Completion Date: Jan 15, 2015
• Actual Study Completion Date: Oct 27, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (chemotherapy) Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Given IV; Other Names: ABI 007 ABI-007 Abraxane ; Other: Laboratory Biomarker Analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Who Have a Confirmed Partial Response or Better [Up to 3 years]

   A confirmed partial response or better will be considered synonymous with "success" and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status on two consecutive evaluations. The percentage of successes (confirmed PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. Confirmed PR or better will be evaluated using all cycles of treatment.

Secondary Outcome Measures

1. Survival Time [Time from registration to death due to any cause, assessed up to 3 years]

   Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

2. Progression Free Survival at 3 Months [Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years]

   The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 3 month progression-free rate (percentage) will be provided. Progression is defined as: Any one or more of the following: Increase of 25% from lowest value in: Serum M-component (absolute increase must be ≥ 0.5 g/dl Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl Urine M-component (absolute increase must be ≥ 200 mg/24 h) If at on study, the only measurable non-bone marrow parameter was free light chain (FLC), the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder Development of new soft tissue plasmacytomas or bone lesions Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl Serum creatinine level ≥2 mg/dl

3. Duration of Response of All Evaluable Patients Who Have Achieved a Partial Response or Better [Date at which the patient's earliest best objective status is first noted to be at least a partial response or better to the earliest date progression is documented, assessed up to 3 years]

   Duration of response is defined for all evaluable patients who have achieved a partial response or better (stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) ) as the date at which the patients earliest best objective status is first noted to be at least a partial response or better to the earliest date of progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

4. Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [Up to 3 years]

   Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.

5. Overall Response Rate [Up to 3 years]

   Overall response rate (percentage) is defined as the percentage of patients with a partial response (PR) or better. A PR or better will be considered synonymous with "success" and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = PR + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status. The percentage of successes (PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. PR or better will be evaluated using all cycles of treatment.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Absolute neutrophil count >= 500/mm^3

• Platelet count >= 25000/mm^3

• Hemoglobin >= 6 g/dL

• Total bilirubin =< 2.5 X institutional upper limit of normal (ULN)

• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 5 X ULN

• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 X ULN

• Creatinine =< 3 mg/dL

• Patients with relapsed or refractory myeloma who have had >= 3 lines of prior therapy

• Measurable disease of multiple myeloma as defined by at least ONE of the following:

• Serum monoclonal protein >= 1.0 g/dL

• 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

• Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio

• Ability to understand and the willingness to sign a written informed consent document

• Negative (serum) pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; NOTE: Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

• Willing to return to enrolling institution (Mayo Clinic in Arizona) for follow-up and all study treatments

Exclusion Criteria:

• Myelosuppressive therapy for myeloma =< 14 days prior to registration or those who have not recovered from acute reversible adverse events due to agents administered > 21 days earlier

• Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are allowed while on protocol treatment; patients may be receiving stable doses of corticosteroids with a maximum dose of 10 mg of prednisone per day if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica or adrenal insufficiency, or asthma

• Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment (i.e. other investigational therapy, anti-neoplastic therapy, etc.) for their cancer

• Any of the following:

• Pregnant women or women of reproductive ability who are unwilling to use effective contraception

• Nursing women - NOTE: breastfeeding should be discontinued if the mother is treated with nab-paclitaxel (Abraxane®)

• Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment

• Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease

• Patients with a >= grade 2 peripheral neuropathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

• Mayo Clinic
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Rafael Fonseca, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01646762
• Other Study ID Numbers: MC1182; NCI-2012-00879; 11-007291; MC1182; P30CA015083
• First Posted: Jul 20, 2012
• Last Update Posted: Oct 16, 2017
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Paclitaxel; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Arm/Group Title	Treatment (Chemotherapy)
Arm/Group Description	Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Period Title: Overall Study
STARTED	13
COMPLETED	13
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment (Chemotherapy)
Arm/Group Description	Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Overall Participants	13
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	70.0
Sex: Female, Male (Count of Participants)
Female	3 23.1%
Male	10 76.9%
Region of Enrollment (Count of Participants)
United States	13 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Who Have a Confirmed Partial Response or Better
Description	A confirmed partial response or better will be considered synonymous with "success" and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status on two consecutive evaluations. The percentage of successes (confirmed PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. Confirmed PR or better will be evaluated using all cycles of treatment.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Chemotherapy)
Arm/Group Description	Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Measure Participants	13
Number (95% Confidence Interval) [percentage of patients]	7.7

2. Secondary Outcome

Title	Survival Time
Description	Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame	Time from registration to death due to any cause, assessed up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Chemotherapy)
Arm/Group Description	Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Measure Participants	13
Median (95% Confidence Interval) [months]	3.7

3. Secondary Outcome

Title	Progression Free Survival at 3 Months
Description	The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 3 month progression-free rate (percentage) will be provided. Progression is defined as: Any one or more of the following: Increase of 25% from lowest value in: Serum M-component (absolute increase must be ≥ 0.5 g/dl Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl Urine M-component (absolute increase must be ≥ 200 mg/24 h) If at on study, the only measurable non-bone marrow parameter was free light chain (FLC), the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder Development of new soft tissue plasmacytomas or bone lesions Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl Serum creatinine level ≥2 mg/dl
Time Frame	Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Chemotherapy)
Arm/Group Description	Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Measure Participants	13
Number [percentage of patients]	25.4

4. Secondary Outcome

Title	Duration of Response of All Evaluable Patients Who Have Achieved a Partial Response or Better
Description	Duration of response is defined for all evaluable patients who have achieved a partial response or better (stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) ) as the date at which the patients earliest best objective status is first noted to be at least a partial response or better to the earliest date of progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Time Frame	Date at which the patient's earliest best objective status is first noted to be at least a partial response or better to the earliest date progression is documented, assessed up to 3 years

Outcome Measure Data

Analysis Population Description

All evaluable patients who have achieved a (unconfirmed or confirmed) partial response or better at the earliest best objective status are included in this analysis

Arm/Group Title	Treatment (Chemotherapy)
Arm/Group Description	Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Measure Participants	2
Median (Full Range) [months]	2.43

5. Secondary Outcome

Title	Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Description	Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Chemotherapy)
Arm/Group Description	Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Measure Participants	13
White blood cell decreased	30.8
Neutrophil count decreased	38.5
Platelet count decreased	38.5
Fatigue	23.1
Anemia	15.4
Anorexia	7.7
Edema limbs	7.7
Hyponatremia	15.4
Epistaxis	7.7
Febrile neutropenia	7.7
Infections and infestations	7.7
Lung infection	7.7

6. Secondary Outcome

Title	Overall Response Rate
Description	Overall response rate (percentage) is defined as the percentage of patients with a partial response (PR) or better. A PR or better will be considered synonymous with "success" and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = PR + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status. The percentage of successes (PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. PR or better will be evaluated using all cycles of treatment.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Chemotherapy)
Arm/Group Description	Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Measure Participants	13
Number (95% Confidence Interval) [percentage of patients]	15

Adverse Events

Time Frame	Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years.
Adverse Event Reporting Description	CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Arm/Group Title	Treatment (Chemotherapy)
Arm/Group Description	Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
All Cause Mortality
	Treatment (Chemotherapy)
	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)
Serious Adverse Events
	Treatment (Chemotherapy)
	Affected / at Risk (%)	# Events
Total	11/13 (84.6%)
Blood and lymphatic system disorders
Anemia	2/13 (15.4%)	3
Febrile neutropenia	1/13 (7.7%)	1
Cardiac disorders
Atrial fibrillation	1/13 (7.7%)	1
Cardiac disorders - Other, specify	1/13 (7.7%)	1
Gastrointestinal disorders
Diarrhea	1/13 (7.7%)	1
Duodenal ulcer	1/13 (7.7%)	1
Dysphagia	1/13 (7.7%)	1
Esophageal necrosis	1/13 (7.7%)	1
Gastric ulcer	1/13 (7.7%)	1
Gastrointestinal disorders - Other, specify	1/13 (7.7%)	1
Nausea	1/13 (7.7%)	1
Vomiting	1/13 (7.7%)	1
General disorders
Edema limbs	1/13 (7.7%)	2
Infections and infestations
Enterocolitis infectious	1/13 (7.7%)	1
Infections and infestations - Other, specify	2/13 (15.4%)	2
Lung infection	3/13 (23.1%)	3
Sepsis	1/13 (7.7%)	2
Investigations
Lymphocyte count decreased	3/13 (23.1%)	6
Neutrophil count decreased	3/13 (23.1%)	3
Platelet count decreased	4/13 (30.8%)	5
White blood cell decreased	1/13 (7.7%)	1
Metabolism and nutrition disorders
Hypercalcemia	3/13 (23.1%)	3
Hyperuricemia	1/13 (7.7%)	1
Hypocalcemia	1/13 (7.7%)	1
Hyponatremia	2/13 (15.4%)	2
Hypophosphatemia	1/13 (7.7%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/13 (7.7%)	2
Generalized muscle weakness	1/13 (7.7%)	1
Nervous system disorders
Encephalopathy	1/13 (7.7%)	1
Somnolence	1/13 (7.7%)	2
Psychiatric disorders
Confusion	1/13 (7.7%)	1
Renal and urinary disorders
Chronic kidney disease	3/13 (23.1%)	3
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/13 (15.4%)	2
Epistaxis	1/13 (7.7%)	1
Respiratory failure	1/13 (7.7%)	2
Skin and subcutaneous tissue disorders
Skin ulceration	1/13 (7.7%)	1
Vascular disorders
Hypotension	1/13 (7.7%)	1
Thromboembolic event	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	Treatment (Chemotherapy)
	Affected / at Risk (%)	# Events
Total	13/13 (100%)
Blood and lymphatic system disorders
Anemia	7/13 (53.8%)	9
Febrile neutropenia	1/13 (7.7%)	1
Gastrointestinal disorders
Diarrhea	8/13 (61.5%)	14
Nausea	7/13 (53.8%)	10
General disorders
Edema limbs	1/13 (7.7%)	3
Fatigue	13/13 (100%)	28
Fever	5/13 (38.5%)	7
Malaise	1/13 (7.7%)	1
Infections and infestations
Bronchial infection	1/13 (7.7%)	2
Sinusitis	1/13 (7.7%)	1
Investigations
Alanine aminotransferase increased	2/13 (15.4%)	2
Aspartate aminotransferase increased	3/13 (23.1%)	4
Blood bilirubin increased	2/13 (15.4%)	2
Creatinine increased	1/13 (7.7%)	1
Lymphocyte count decreased	5/13 (38.5%)	6
Neutrophil count decreased	11/13 (84.6%)	18
Platelet count decreased	7/13 (53.8%)	11
White blood cell decreased	13/13 (100%)	23
Metabolism and nutrition disorders
Anorexia	3/13 (23.1%)	6
Hyperglycemia	2/13 (15.4%)	3
Hyperuricemia	1/13 (7.7%)	1
Nervous system disorders
Peripheral motor neuropathy	1/13 (7.7%)	2
Peripheral sensory neuropathy	12/13 (92.3%)	26
Respiratory, thoracic and mediastinal disorders
Dyspnea	8/13 (61.5%)	16
Skin and subcutaneous tissue disorders
Alopecia	1/13 (7.7%)	2
Pruritus	2/13 (15.4%)	5
Rash maculo-papular	5/13 (38.5%)	11
Vascular disorders
Hypotension	4/13 (30.8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.