Trial Outcomes & Findings for Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Sarcomatoid Renal Cell Carcinoma (NCT NCT00496587)

Last Updated: 2017-07-19

Results Overview

Event or disease-free survival given as progression free survival (PFS) which was defined as the length of time after primary treatment that the participant survives without disease progression. Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

12 months or until progression of disease

Results posted on

2017-07-19

Participant Flow

Recruitment Period: July 2, 2007 to February 24, 2012. All recruitment done at The University of Texas Cancer Center.

Participant milestones

Participant milestones
Measure	Capecitabine + Gemcitabine + Bevacizumab Capecitabine 800 mg/m\^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m\^2 intravenous (IV) Days 1 \&15 and Bevacizumab 10 mg/kg IV Days 1 \& 15.
Overall Study STARTED	34
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Capecitabine + Gemcitabine + Bevacizumab Capecitabine 800 mg/m\^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m\^2 intravenous (IV) Days 1 \&15 and Bevacizumab 10 mg/kg IV Days 1 \& 15.
Overall Study Adverse Event	2
Overall Study Progressive Disease	24
Overall Study Withdrawal by Subject	2
Overall Study Death	1
Overall Study Complications unrelated	2

Baseline Characteristics

Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Sarcomatoid Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine + Gemcitabine + Bevacizumab n=34 Participants Capecitabine 800 mg/m\^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m\^2 intravenous (IV) Days 1 \&15 and Bevacizumab 10 mg/kg IV Days 1 \& 15.
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months or until progression of disease

Population: One participant was excluded from survival analysis due to missing data.

Outcome measures

Outcome measures
Measure	Capecitabine + Gemcitabine + Bevacizumab n=33 Participants Capecitabine 800 mg/m\^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m\^2 intravenous (IV) Days 1 \&15 and Bevacizumab 10 mg/kg IV Days 1 \& 15.
Progression Free Survival (PFS)	5.5 Months Interval 3.4 to 7.7

PRIMARY outcome

Timeframe: 12 months or until progression of disease

Population: Four participants were excluded from response analysis due to missing data.

Time to treatment failure, TTF, with failure defined as death or disease progression where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.

Outcome measures

Outcome measures
Measure	Capecitabine + Gemcitabine + Bevacizumab n=30 Participants Capecitabine 800 mg/m\^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m\^2 intravenous (IV) Days 1 \&15 and Bevacizumab 10 mg/kg IV Days 1 \& 15.
Time to Treatment Failure (TTF)	4.2 Months Interval 2.4 to 6.0

SECONDARY outcome

Timeframe: 12 months or until progression of disease

Population: Four participants were excluded from response analysis due to missing data.

Objective response defined as Complete Response + Partial Response, with response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response: The disappearance of all target lesions. Partial Response: \>30% decrease in the sum of the longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since the treatment started.

Outcome measures

Outcome measures
Measure	Capecitabine + Gemcitabine + Bevacizumab n=30 Participants Capecitabine 800 mg/m\^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m\^2 intravenous (IV) Days 1 \&15 and Bevacizumab 10 mg/kg IV Days 1 \& 15.
Objective Response Rate (ORR)	20 percentage of participants

Adverse Events

Capecitabine + Gemcitabine + Bevacizumab

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Capecitabine + Gemcitabine + Bevacizumab n=34 participants at risk Capecitabine 800 mg/m\^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m\^2 intravenous (IV) Days 1 \&15 and Bevacizumab 10 mg/kg IV Days 1 \& 15.
Investigations Bilirubin (hyperbilirubinemia)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Vascular disorders Thrombosis/embolism (vascular access-related)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Vascular disorders Thrombosis/thrombus/embolism	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Vascular disorders Hypotension	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
General disorders Abdominal Pain	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.

Other adverse events

Other adverse events
Measure	Capecitabine + Gemcitabine + Bevacizumab n=34 participants at risk Capecitabine 800 mg/m\^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m\^2 intravenous (IV) Days 1 \&15 and Bevacizumab 10 mg/kg IV Days 1 \& 15.
Gastrointestinal disorders Abdominal pain	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Investigations Activated partial thromboplastin time prolonged	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	23.5% 8/34 • Number of events 12 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Investigations Alkaline phosphatase	29.4% 10/34 • Number of events 13 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	8.8% 3/34 • Number of events 6 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Immune system disorders Allergy/Immunology	14.7% 5/34 • Number of events 7 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	20.6% 7/34 • Number of events 9 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Anemia	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Anorexia	55.9% 19/34 • Number of events 23 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Respiratory, thoracic and mediastinal disorders Aspiration	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	20.6% 7/34 • Number of events 11 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Back pain	2.9% 1/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Bicarbonate, serum-low	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	14.7% 5/34 • Number of events 7 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Injury, poisoning and procedural complications Bruising (in absence of Grade 3 or 4 thrombocytopenia)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	11.8% 4/34 • Number of events 4 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	8.8% 3/34 • Number of events 4 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Cardiac disorders Cardiac General-Other	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Cervical spine-range of motion	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Investigations Cholesterol high	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Constipation	35.3% 12/34 • Number of events 22 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
General disorders Constitutional Symptoms	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
General disorders Cough	23.5% 8/34 • Number of events 17 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Investigations Creatinine	35.3% 12/34 • Number of events 21 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Investigations Creatinine increased	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Dehydration	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other	8.8% 3/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Diarrhea	29.4% 10/34 • Number of events 26 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Nervous system disorders Dizziness	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	11.8% 4/34 • Number of events 5 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Dry skin	38.2% 13/34 • Number of events 24 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	2.9% 1/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Cardiac disorders Dyspnea	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Cardiac disorders Dyspnea (shortness of breath)	41.2% 14/34 • Number of events 23 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Edema: head and neck	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Edema: limb	14.7% 5/34 • Number of events 5 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Endocrine disorders Endocrine	14.7% 5/34 • Number of events 7 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Esophagitis	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
General disorders Fatigue	2.9% 1/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
General disorders Fatigue (asthenia, lethargy, malaise)	70.6% 24/34 • Number of events 69 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Fever	8.8% 3/34 • Number of events 4 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Gastrointestinal	14.7% 5/34 • Number of events 8 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	50.0% 17/34 • Number of events 45 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	8.8% 3/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Heartburn/dyspepsia	5.9% 2/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Hemoglobin	82.4% 28/34 • Number of events 54 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Hemoglobinuria	11.8% 4/34 • Number of events 4 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Hemorrhage, GU--Select	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory	5.9% 2/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Hemorrhage/Bleeding	11.8% 4/34 • Number of events 7 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	8.8% 3/34 • Number of events 4 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Respiratory, thoracic and mediastinal disorders Hiccups	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Reproductive system and breast disorders Hot flashes/flushes	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Hyperglycemia	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Hyperkalemia	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Hyperpigmentation	8.8% 3/34 • Number of events 6 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Endocrine disorders Hypertension (Adult)	5.9% 2/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Endocrine disorders Hypertension (Pediatric)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Hypertriglyceridemia	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Hyperuricemia	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Endocrine disorders Hypotension	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Infections and infestations Infection	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Psychiatric disorders Insomnia	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Joint	2.9% 1/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Joint-function	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Leukocytes (Total WBC)	8.8% 3/34 • Number of events 8 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Lymphatics	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Lymphopenia	23.5% 8/34 • Number of events 22 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Psychiatric disorders Mood alteration	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Psychiatric disorders Mood alteration (Anxiety)	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Psychiatric disorders Mood alteration (Depression)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Mucositis oral	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam)	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) (Oral Cavity)	14.7% 5/34 • Number of events 9 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) (Oral Cavity)	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) (Stomach)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity - lower)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue-Other	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Nail changes	8.8% 3/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Nausea	52.9% 18/34 • Number of events 40 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Nervous system disorders Neurology	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Nervous system disorders Neuropathy: motor	8.8% 3/34 • Number of events 7 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Nervous system disorders Neuropathy: sensory	35.3% 12/34 • Number of events 29 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	8.8% 3/34 • Number of events 5 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Obstruction, GI--Select (Small bowel NOS)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
General disorders Pain	73.5% 25/34 • Number of events 95 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Pain--Select (Abdomen NOS)	11.8% 4/34 • Number of events 6 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Pain--Select (Back)	17.6% 6/34 • Number of events 10 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Pain--Select (Extremity-limb)	2.9% 1/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Nervous system disorders Pain--Select (Head/headache)	8.8% 3/34 • Number of events 4 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Musculoskeletal and connective tissue disorders Pain--Select (Neck)	2.9% 1/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Pain--Select (Oral Cavity)	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Pain--Select (Oral-gums)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Reproductive system and breast disorders Pain--Select (Pelvis)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Blood and lymphatic system disorders Platelets	14.7% 5/34 • Number of events 9 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Potassium serum-high (hyperkalemia)	14.7% 5/34 • Number of events 7 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	5.9% 2/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Renal and urinary disorders Proteinuria	47.1% 16/34 • Number of events 29 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Pruritus/itching	5.9% 2/34 • Number of events 4 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Investigations PTT (Partial Thromboplastin Time)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-Other	11.8% 4/34 • Number of events 7 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Rash/desquamation	17.6% 6/34 • Number of events 18 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	55.9% 19/34 • Number of events 78 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Renal and urinary disorders Renal/Genitourinary	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
General disorders Rigors/chills	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Small/Large intestine	5.9% 2/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Sodium serum-low (hyponatremia)	26.5% 9/34 • Number of events 14 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Cardiac disorders Supraventricular and nodal arrhythmia	5.9% 2/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Cardiac disorders Supraventricular and nodal arrhythmia--Select (Sinus tachycardia)	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
General disorders Sweating (diaphoresis)	14.7% 5/34 • Number of events 5 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Nervous system disorders Taste alteration (dysgeusia)	20.6% 7/34 • Number of events 7 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Vascular disorders Thrombosis/embolism (vascular access-related)	5.9% 2/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Vascular disorders Thrombosis/thrombus/embolism	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Triglyceride, serum-high (hypertriglyceridemia)	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	11.8% 4/34 • Number of events 5 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Renal and urinary disorders Urinary frequency/urgency	8.8% 3/34 • Number of events 3 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Renal and urinary disorders Urine color change	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Reproductive system and breast disorders Vaginal dryness	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Nervous system disorders Voice changes/dysarthria	8.8% 3/34 • Number of events 4 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Vomiting	29.4% 10/34 • Number of events 16 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Eye disorders Watering eyes	2.9% 1/34 • Number of events 1 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
Gastrointestinal disorders Weight loss	5.9% 2/34 • Number of events 2 • Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.

Additional Information

Dr. Nazir Tannir/

The University of Texas MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place