Trial Outcomes & Findings for Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer (NCT NCT00609791)

Last Updated: 2025-06-19

Results Overview

Mean of area under the curve over 24 hours (AUC24) reported as well as linear regression of AUC24 by age and chemotherapy toxicity risk score. Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19: patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

Results posted on

2025-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Nab-paclitaxel paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nab-paclitaxel paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Overall Study Subject was deemed ineligible after starting study procedures	1

Baseline Characteristics

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-paclitaxel n=39 Participants paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Age, Continuous	60 years n=93 Participants
Age, Customized <50	10 Participants n=93 Participants
Age, Customized 50-59	5 Participants n=93 Participants
Age, Customized 60-69	15 Participants n=93 Participants
Age, Customized >=70	9 Participants n=93 Participants
Sex: Female, Male Female	39 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	7 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	30 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	39 participants n=93 Participants

PRIMARY outcome

Timeframe: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

Population: Three participants did not have AUC data through 24 hours post treatment due to incomplete blood samples

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=36 Participants paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Mean Area Under the Curve Over 24 Hours (AUC24)	4711 µg/mL*hour Standard Deviation 2777

PRIMARY outcome

Timeframe: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

Population: Nine participants did not have CL data due to incomplete blood samples

Mean CL reported as well as regression results of CL by age and chemotherapy toxicity risk score. Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19: patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=30 Participants paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Mean Clearance (CL)	37.16 L/h Standard Deviation 14.81

SECONDARY outcome

Timeframe: Up to 2.5 years

Comparison of presence of grade 3 toxicity rate by risk score distribution. Chemotherapy toxicity risk score is based on the following variables. Higher scores indicate more risk, range of 2-19: patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type Chemotherapy toxicity risk score category: Low risk score - toxicity risk score: 0-5 Medium risk score - toxicity risk score: 6-9 High risk score - toxicity risk score: 10-19

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=39 Participants paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score Low risk score : Grade 3 toxicity	5 Participants
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score Low risk score : No grade 3 toxicity	25 Participants
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score Medium risk score : Grade 3 toxicity	3 Participants
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score Medium risk score : No grade 3 toxicity	3 Participants
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score High risk score : Grade 3 toxicity	2 Participants
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score High risk score : No grade 3 toxicity	1 Participants

SECONDARY outcome

Timeframe: Assessed after every 2 cycles of therapy until progression, up to 2.5 years

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=39 Participants paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Best Response Partial Remission	12 Participants
Best Response Stable Disease	15 Participants
Best Response Progressive Disease	10 Participants
Best Response Not evaluable	2 Participants

SECONDARY outcome

Timeframe: From the date treatment begins until the first date on which recurrence, progression or death due to any cause, assessed up to 3.5 years

Median and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for EFS. EFS will be estimated using the product limit method of Kaplan and Meier. EFS is defined by time to disease recurrence, disease progression or death to due to any cause

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=39 Participants paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Median Event-free Survival (EFS) in Months	5.7 months Interval 3.2 to 9.2

SECONDARY outcome

Timeframe: At the completion of treatment, up to 2.5 years

Number of participants requiring a dose reduction is reported and analysis was performed using a student's 2 sample t test to determine the need of dose reductions based on age, AUC, and CL.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=39 Participants paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Number of Participants Requiring Dose Reductions	11 Participants

SECONDARY outcome

Timeframe: At the completion of treatment, up to 2.5 years

Number of participants with a dose omission is reported and analysis was performed using a student's 2 sample t test to determine the need of dose omission based on age, AUC, and CL.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=39 Participants paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Number of Participants With a Dose Omission	15 Participants

SECONDARY outcome

Timeframe: At the completion of treatment, up to 2.5 years

Percent of participants experiencing a grade 3 toxicity is reported and analysis was performed using a student's 2 sample t test to determine the presence of grade 3 toxicity based on age, AUC, and CL.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=39 Participants paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Percent of Participants With a Grade 3 Toxicity	26 percentage of participants Interval 13.0 to 42.0

Adverse Events

Nab-paclitaxel

Serious events: 2 serious events

Other events: 39 other events

Deaths: 26 deaths

Serious adverse events

Serious adverse events
Measure	Nab-paclitaxel n=39 participants at risk paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Infections and infestations Urinary tract infection	2.6% 1/39 • Up to 3.5 years
Infections and infestations Skin infection	2.6% 1/39 • Up to 3.5 years

Other adverse events

Other adverse events
Measure	Nab-paclitaxel n=39 participants at risk paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Immune system disorders Allergic rhinitis	10.3% 4/39 • Up to 3.5 years
Immune system disorders Hypersensitivity	2.6% 1/39 • Up to 3.5 years
Immune system disorders Immune system disorder	2.6% 1/39 • Up to 3.5 years
Ear and labyrinth disorders Tinnitus	2.6% 1/39 • Up to 3.5 years
Investigations Hemoglobin decreased	92.3% 36/39 • Up to 3.5 years
Investigations Leukocyte count decreased	69.2% 27/39 • Up to 3.5 years
Investigations Lymphocyte count decreased	38.5% 15/39 • Up to 3.5 years
Investigations Neutrophil count decreased	48.7% 19/39 • Up to 3.5 years
Investigations Platelet count decreased	17.9% 7/39 • Up to 3.5 years
Cardiac disorders Atrial fibrillation	2.6% 1/39 • Up to 3.5 years
Cardiac disorders Palpitations	2.6% 1/39 • Up to 3.5 years
Cardiac disorders Sinus bradycardia	2.6% 1/39 • Up to 3.5 years
Cardiac disorders Sinus tachycardia	2.6% 1/39 • Up to 3.5 years
Cardiac disorders Hypertension	20.5% 8/39 • Up to 3.5 years
General disorders Edema	2.6% 1/39 • Up to 3.5 years
Investigations Activated partial thromboplastin time prolonged	2.6% 1/39 • Up to 3.5 years
General disorders Chills	2.6% 1/39 • Up to 3.5 years
General disorders Fatigue	69.2% 27/39 • Up to 3.5 years
General disorders Fever	7.7% 3/39 • Up to 3.5 years
Psychiatric disorders Insomnia	5.1% 2/39 • Up to 3.5 years
Metabolism and nutrition disorders Obesity	2.6% 1/39 • Up to 3.5 years
Skin and subcutaneous tissue disorders Sweating	2.6% 1/39 • Up to 3.5 years
Investigations Weight gain	2.6% 1/39 • Up to 3.5 years
Investigations Weight loss	7.7% 3/39 • Up to 3.5 years
Skin and subcutaneous tissue disorders Alopecia	5.1% 2/39 • Up to 3.5 years
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	5.1% 2/39 • Up to 3.5 years
General disorders Injection site reaction	2.6% 1/39 • Up to 3.5 years
Skin and subcutaneous tissue disorders Nail disorder	5.1% 2/39 • Up to 3.5 years
Skin and subcutaneous tissue disorders Pruritus	7.7% 3/39 • Up to 3.5 years
Skin and subcutaneous tissue disorders Rash desquamating	23.1% 9/39 • Up to 3.5 years
Skin and subcutaneous tissue disorders Skin disorder	12.8% 5/39 • Up to 3.5 years
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.6% 1/39 • Up to 3.5 years
Metabolism and nutrition disorders Glucose intolerance	7.7% 3/39 • Up to 3.5 years
Vascular disorders Hot flashes	20.5% 8/39 • Up to 3.5 years
Endocrine disorders Hypothyroidism	2.6% 1/39 • Up to 3.5 years
Metabolism and nutrition disorders Anorexia	7.7% 3/39 • Up to 3.5 years
Gastrointestinal disorders Ascites	2.6% 1/39 • Up to 3.5 years
Gastrointestinal disorders Constipation	20.5% 8/39 • Up to 3.5 years
Metabolism and nutrition disorders Dehydration	5.1% 2/39 • Up to 3.5 years
Gastrointestinal disorders Diarrhea	28.2% 11/39 • Up to 3.5 years
Gastrointestinal disorders Dry mouth	2.6% 1/39 • Up to 3.5 years
Gastrointestinal disorders Dyspepsia	7.7% 3/39 • Up to 3.5 years
Gastrointestinal disorders Enteritis	2.6% 1/39 • Up to 3.5 years
Gastrointestinal disorders Flatulence	2.6% 1/39 • Up to 3.5 years
Gastrointestinal disorders Gastric ulcer	2.6% 1/39 • Up to 3.5 years
Gastrointestinal disorders Hemorrhoids	2.6% 1/39 • Up to 3.5 years
Gastrointestinal disorders Nausea	38.5% 15/39 • Up to 3.5 years
Gastrointestinal disorders Mucositis	5.1% 2/39 • Up to 3.5 years
Nervous system disorders Dysgeusia	5.1% 2/39 • Up to 3.5 years
Gastrointestinal disorders Typhlitis	2.6% 1/39 • Up to 3.5 years
Gastrointestinal disorders Vomiting	17.9% 7/39 • Up to 3.5 years
Gastrointestinal disorders Hemorrhage	7.7% 3/39 • Up to 3.5 years
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.6% 1/39 • Up to 3.5 years
Renal and urinary disorders Ureteric hemorrhage	2.6% 1/39 • Up to 3.5 years
Hepatobiliary disorders Hepatobiliary disease	2.6% 1/39 • Up to 3.5 years
Infections and infestations Bladder infection	5.1% 2/39 • Up to 3.5 years
Infections and infestations Catheter related infection	2.6% 1/39 • Up to 3.5 years
Infections and infestations Gingival infection	2.6% 1/39 • Up to 3.5 years
Infections and infestations Infection	2.6% 1/39 • Up to 3.5 years
Infections and infestations Infectious colitis	2.6% 1/39 • Up to 3.5 years
Infections and infestations Pharyngitis	2.6% 1/39 • Up to 3.5 years
Infections and infestations Scrotal infection	2.6% 1/39 • Up to 3.5 years
Infections and infestations Sinusitis	10.3% 4/39 • Up to 3.5 years
Infections and infestations Skin infection	2.6% 1/39 • Up to 3.5 years
Infections and infestations Small intestine infection	2.6% 1/39 • Up to 3.5 years
Infections and infestations Upper aerodigestive tract infection	2.6% 1/39 • Up to 3.5 years
Infections and infestations Upper respiratory infection	20.5% 8/39 • Up to 3.5 years
Infections and infestations Urinary tract infection	10.3% 4/39 • Up to 3.5 years
Infections and infestations Infection without neutropenia	2.6% 1/39 • Up to 3.5 years
General disorders Edema limbs	28.2% 11/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Fibrosis	5.1% 2/39 • Up to 3.5 years
General disorders Localized edema	7.7% 3/39 • Up to 3.5 years
Vascular disorders Lymphedema	2.6% 1/39 • Up to 3.5 years
Investigations Alanine aminotransferase increased	20.5% 8/39 • Up to 3.5 years
Investigations Alkaline phosphatase increased	56.4% 22/39 • Up to 3.5 years
Investigations Aspartate aminotransferase increased	64.1% 25/39 • Up to 3.5 years
Metabolism and nutrition disorders Hyperglycemia	59.0% 23/39 • Up to 3.5 years
Investigations Creatine phosphokinase increased	2.6% 1/39 • Up to 3.5 years
Investigations Creatinine increased	12.8% 5/39 • Up to 3.5 years
Investigations Protein urine positive	2.6% 1/39 • Up to 3.5 years
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 13/39 • Up to 3.5 years
Metabolism and nutrition disorders Hypocalcemia	15.4% 6/39 • Up to 3.5 years
Metabolism and nutrition disorders Hypercalcemia	7.7% 3/39 • Up to 3.5 years
Metabolism and nutrition disorders Hypercholesteremia	15.4% 6/39 • Up to 3.5 years
Metabolism and nutrition disorders Hypoglycemia	12.8% 5/39 • Up to 3.5 years
Metabolism and nutrition disorders Hypermagnesemia	5.1% 2/39 • Up to 3.5 years
Metabolism and nutrition disorders Hypophosphatemia	7.7% 3/39 • Up to 3.5 years
Metabolism and nutrition disorders Hypokalemia	25.6% 10/39 • Up to 3.5 years
Metabolism and nutrition disorders Hyperkalemia	7.7% 3/39 • Up to 3.5 years
Metabolism and nutrition disorders Hyponatremia	30.8% 12/39 • Up to 3.5 years
Metabolism and nutrition disorders Hypertriglyceridemia	2.6% 1/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Arthritis	2.6% 1/39 • Up to 3.5 years
Injury, poisoning and procedural complications Fracture	2.6% 1/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Osteoporosis	2.6% 1/39 • Up to 3.5 years
Psychiatric disorders Agitation	2.6% 1/39 • Up to 3.5 years
Psychiatric disorders Anxiety	28.2% 11/39 • Up to 3.5 years
Nervous system disorders Ataxia	2.6% 1/39 • Up to 3.5 years
Nervous system disorders Cognitive disturbance	2.6% 1/39 • Up to 3.5 years
Psychiatric disorders Confusion	7.7% 3/39 • Up to 3.5 years
Nervous system disorders Depressed level of consciousness	5.1% 2/39 • Up to 3.5 years
Psychiatric disorders Depression	12.8% 5/39 • Up to 3.5 years
Nervous system disorders Dizziness	10.3% 4/39 • Up to 3.5 years
Nervous system disorders Memory impairment	10.3% 4/39 • Up to 3.5 years
Nervous system disorders Peripheral sensory neuropathy	48.7% 19/39 • Up to 3.5 years
Nervous system disorders Tremor	2.6% 1/39 • Up to 3.5 years
Nervous system disorders Trigeminal nerve disorder	2.6% 1/39 • Up to 3.5 years
Eye disorders Dry eye syndrome	12.8% 5/39 • Up to 3.5 years
Eye disorders Eyelid function disorder	2.6% 1/39 • Up to 3.5 years
Eye disorders Vision blurred	2.6% 1/39 • Up to 3.5 years
Eye disorders Watering eyes	7.7% 3/39 • Up to 3.5 years
Gastrointestinal disorders Abdominal pain	25.6% 10/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Back pain	35.9% 14/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Bone pain	28.2% 11/39 • Up to 3.5 years
Reproductive system and breast disorders Breast pain	5.1% 2/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Buttock pain	2.6% 1/39 • Up to 3.5 years
Cardiac disorders Chest pain	10.3% 4/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Chest wall pain	2.6% 1/39 • Up to 3.5 years
Ear and labyrinth disorders Ear pain	2.6% 1/39 • Up to 3.5 years
Ear and labyrinth disorders External ear pain	2.6% 1/39 • Up to 3.5 years
General disorders Facial pain	2.6% 1/39 • Up to 3.5 years
Nervous system disorders Headache	17.9% 7/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Joint pain	30.8% 12/39 • Up to 3.5 years
Blood and lymphatic system disorders Lymph node pain	2.6% 1/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Myalgia	12.8% 5/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Neck pain	7.7% 3/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Pain	28.2% 11/39 • Up to 3.5 years
Musculoskeletal and connective tissue disorders Pain in extremity	12.8% 5/39 • Up to 3.5 years
Reproductive system and breast disorders Pelvic pain	5.1% 2/39 • Up to 3.5 years
Gastrointestinal disorders Peritoneal pain	2.6% 1/39 • Up to 3.5 years
Gastrointestinal disorders Stomach pain	2.6% 1/39 • Up to 3.5 years
Renal and urinary disorders Urethral pain	2.6% 1/39 • Up to 3.5 years
Respiratory, thoracic and mediastinal disorders Cough	28.2% 11/39 • Up to 3.5 years
Respiratory, thoracic and mediastinal disorders Dyspnea	20.5% 8/39 • Up to 3.5 years
Respiratory, thoracic and mediastinal disorders Laryngeal edema	2.6% 1/39 • Up to 3.5 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.6% 1/39 • Up to 3.5 years
Respiratory, thoracic and mediastinal disorders Voice alteration	7.7% 3/39 • Up to 3.5 years
Renal and urinary disorders Cystitis	2.6% 1/39 • Up to 3.5 years
Renal and urinary disorders Ureteric obstruction	5.1% 2/39 • Up to 3.5 years
Renal and urinary disorders Urinary frequency	2.6% 1/39 • Up to 3.5 years
Renal and urinary disorders Urinary retention	2.6% 1/39 • Up to 3.5 years
Renal and urinary disorders Urine discoloration	2.6% 1/39 • Up to 3.5 years
Renal and urinary disorders Urogenital disorder	2.6% 1/39 • Up to 3.5 years
Reproductive system and breast disorders Irregular menstruation	2.6% 1/39 • Up to 3.5 years
Reproductive system and breast disorders Vaginal dryness	5.1% 2/39 • Up to 3.5 years

Additional Information

Dr. Mina Sedrak

City of Hope

Phone: 6263598111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place