Trial Outcomes & Findings for Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer (NCT NCT01118351)

NCT ID: NCT01118351

Last Updated: 2019-05-01

Results Overview

Number of patients with complete response defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology 12 months after treatment with sunitinib.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: At 12 months after completion of treatment
• Results posted on: 2019-05-01

Participant Flow

Participant milestones

Measure	Arm I Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Study STARTED	19
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Arm I Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

Baseline characteristics by cohort

Measure	Arm I n=19 Participants Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies
Age, Continuous	72 Years n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 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	0 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	0 Participants n=93 Participants
Race (NIH/OMB) White	19 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	19 participants n=93 Participants

PRIMARY outcome

Timeframe: At 12 months after completion of treatment

Population: All patients who received treatment and completed the 12 month follow up.

Number of patients with complete response defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology 12 months after treatment with sunitinib.

Outcome measures

Measure

Arm I n=18 Participants Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies

Complete Response Rate

4 Participants

SECONDARY outcome

Timeframe: at 12 months after completion of treatment

Population: Patients that received treatment and completed follow up.

Time from registration (up to 28 days prior to treatment) to the first documentation of recurrence assessed up to 12 months after completion of treatment (up to 12 weeks). Time period can be up to 16 months from time of registration.

Outcome measures

Measure

Arm I n=18 Participants Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies

Recurrence-free Survival

3 months Interval 3.0 to 16.0

SECONDARY outcome

Timeframe: at 12 months after completion of treatment

Population: All patients who received treatment and completed follow up.

Number of patients last known to be alive and not to have progressed are censored at the last day of contact. Progression is defined as: Biopsy proven muscle invasive disease ≥ Stage T2 or death due to any cause.

Outcome measures

Measure

Arm I n=18 Participants Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies

Progression-free Survival

4 Participants

SECONDARY outcome

Timeframe: at 12 months after completion of treatment

Population: All patients that received treatment and completed follow up.

Number of patients still alive from date of registration to date of death due to any cause.

Outcome measures

Measure

Arm I n=18 Participants Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies

Overall Survival

18 Participants

SECONDARY outcome

Timeframe: at 12 months after completion of treatment

Population: All participants that received treatment

Number of participants that experienced adverse events.

Outcome measures

Measure

Arm I n=19 Participants Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies

Toxicity Assessed, Graded, and Tabulated Using CTCAE Version 3.0

19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at 12 months after completion of treatment

The secondary outcome measure of response for the correlative studies will be the degree of apoptosis and the overexpression or not of known angiogenic markers (i.e. VEGF-R2, PDGF-R) an comparison by IHC analysis within bladder tumor tissue from the TURBT biopsy specimens with the post sunitinib (Sutent®) treatment TURBT specimens.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at 12 months after completion of treatment

The secondary outcome measure of response for the correlative studies will be the degree of apoptosis and the overexpression or not of known angiogenic markers (i.e. VEGF-R2, PDGF-R) an comparison by IHC analysis within bladder tumor tissue from the TURBT biopsy specimens with the post sunitinib (Sutent®) treatment TURBT specimens.

Outcome measures

Outcome data not reported

Adverse Events

Arm I

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=19 participants at risk Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies
Hepatobiliary disorders Cholecystitis	5.3% 1/19 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Hemorrhage, GI - Rectum	5.3% 1/19 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Renal and urinary disorders Hemorrhage, GU - Urinary NOS	5.3% 1/19 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Cardiac disorders Hypertension	5.3% 1/19 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Blood and lymphatic system disorders Infection with normal ANC or Grade 1 or 2 neutrophils	5.3% 1/19 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Pain - Abdomen NOS	5.3% 1/19 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Blood and lymphatic system disorders Platelets	5.3% 1/19 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Renal and urinary disorders Renal failure	5.3% 1/19 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.

Other adverse events

Measure	Arm I n=19 participants at risk Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given orally immunohistochemistry staining method: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies light microscopy: Correlative studies laboratory biomarker analysis: Correlative studies
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	10.5% 2/19 • Number of events 4 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Alkaline phosphatase	5.3% 1/19 • Number of events 3 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	10.5% 2/19 • Number of events 4 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Anorexia	36.8% 7/19 • Number of events 10 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	26.3% 5/19 • Number of events 9 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Bicarbonate, serum-low	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	15.8% 3/19 • Number of events 6 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	10.5% 2/19 • Number of events 3 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Nervous system disorders Cognitive disturbance	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Constipation	26.3% 5/19 • Number of events 7 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Cold Intolerance	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Creatinine	26.3% 5/19 • Number of events 5 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Skin Lesion	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Diarrhea	68.4% 13/19 • Number of events 22 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Distension/bloating, abdominal	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Nervous system disorders Dizziness	21.1% 4/19 • Number of events 4 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Dry skin	10.5% 2/19 • Number of events 3 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	21.1% 4/19 • Number of events 5 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Edema: head and neck	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Edema: limb	26.3% 5/19 • Number of events 5 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Fatigue (asthenia, lethargy, malaise)	73.7% 14/19 • Number of events 22 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Flatulence	26.3% 5/19 • Number of events 5 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Flu-like syndrome	26.3% 5/19 • Number of events 7 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Cramps	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders GGT (gamma-Glutamyl transpeptidase)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	26.3% 5/19 • Number of events 8 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	15.8% 3/19 • Number of events 3 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Heartburn/dyspepsia	63.2% 12/19 • Number of events 19 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Blood and lymphatic system disorders Hemoglobin	63.2% 12/19 • Number of events 27 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Hemorrhage, GI - Rectum	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Hemorrhage, GI - Varices (rectal)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Renal and urinary disorders Hemorrhage, GU - Bladder	5.3% 1/19 • Number of events 4 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Renal and urinary disorders Hemorrhage, GU - Urinary NOS	5.3% 1/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	21.1% 4/19 • Number of events 4 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Cardiac disorders Hypertension	42.1% 8/19 • Number of events 10 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Hypopigmentation	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Bladder (urinary)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Mucosa	5.3% 1/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Infections and infestations Infection with unknown ANC - Urinary tract NOS	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Blood and lymphatic system disorders INR (International Normalized Ratio of prothrombin time)	15.8% 3/19 • Number of events 3 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Insomnia	21.1% 4/19 • Number of events 4 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Blood and lymphatic system disorders Leukocytes (total WBC)	73.7% 14/19 • Number of events 22 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Blood and lymphatic system disorders Lymphopenia	42.1% 8/19 • Number of events 20 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Nervous system disorders Memory impairment	5.3% 1/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Nervous system disorders Mood alteration - Anxiety	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	15.8% 3/19 • Number of events 4 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - Esophagus	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - Oral cavity	42.1% 8/19 • Number of events 16 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Nail changes	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Nausea	15.8% 3/19 • Number of events 3 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Nervous system disorders Light/dark adaptation	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	42.1% 8/19 • Number of events 11 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Eye disorders Retinal tears	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Pain - Abdomen NOS	5.3% 1/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Pain - Anus	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Pain - Extremity-limb	10.5% 2/19 • Number of events 3 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Pain - Head/headache	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Pain - Joint	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Pain - Middle ear	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Pain - Oral cavity	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Diffuse Arthralgia	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Blood and lymphatic system disorders Platelets	89.5% 17/19 • Number of events 41 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	10.5% 2/19 • Number of events 7 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Pruritus/itching	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Blood and lymphatic system disorders PTT (Partial Thromboplastin Time)	10.5% 2/19 • Number of events 3 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Rash/desquamation	15.8% 3/19 • Number of events 6 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	36.8% 7/19 • Number of events 16 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Renal and urinary disorders Hemorrhage/Hematuria (Intermittent)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Rigors/chills	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Nervous system disorders Seizure	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Skin breakdown/decubitus ulcer	5.3% 1/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	21.1% 4/19 • Number of events 7 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Renal and urinary disorders Stricture/stenosis (including anastomotic), GU - Urethra	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Cardiac disorders Supraventricular and nodal arrhythmia - Sinus tachycardia	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Sweating (diaphoresis)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Syndromes - Other (Cold)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Taste alteration (dysgeusia)	84.2% 16/19 • Number of events 21 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	10.5% 2/19 • Number of events 3 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Renal and urinary disorders Urine color change	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Urticaria (hives, welts, wheals)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Vomiting	10.5% 2/19 • Number of events 2 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
General disorders Weight loss	10.5% 2/19 • Number of events 4 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Skin-Yellowing	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Tender Scalp	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Greying/course hair	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Skin and subcutaneous tissue disorders Warm, tight "sunburn-like" skin	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders GI (Other)-Dry Mucous Membranes, Nasal	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Stomach "cramping" with flatulence	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Eye disorders Visual disturbance	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Pain, Abdominal (Gas Cramps)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Gastrointestinal disorders Pain, Chest (Gas Cramps)	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.
Renal and urinary disorders Urinary, burning	5.3% 1/19 • Number of events 1 • Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.

Additional Information

Dr. Jorge Garcia

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Phone: 216-444-7774

Email: garciaj4@case.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place