Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Stage IV Kidney Cancer (NCT NCT01157091)

Last Updated: 2022-06-08

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

1 year post treatment

Results posted on

2022-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Pazopanib HCl Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pazopanib Hydrochloride in Treating Patients With Stage IV Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=28 Participants Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	63.1 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Non-Hispanic	4 Participants n=5 Participants
Race/Ethnicity, Customized White/Hispanic or Latino	8 Participants n=5 Participants
Race/Ethnicity, Customized White/Non-Hispanic	16 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year post treatment

Population: Participants with evaluable results.

Outcome measures

Outcome measures
Measure	Arm I n=25 Participants Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by RECIST 1.1 Criteria Complete or Partial Response	14 Participants
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by RECIST 1.1 Criteria Stable	7 Participants
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by RECIST 1.1 Criteria Progression	4 Participants

SECONDARY outcome

Timeframe: 1 year post treatment

Kaplan-meier estimate of Progression-free survival, one-year post enrollment in the study. 95% Confidence Intervals are constructed using the Greenwood estimate of variance and log-log transformation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or an unequivocal measured increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Arm I n=28 Participants Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Progression-free Survival	70.0 percentage of participants Interval 48.7 to 83.8

SECONDARY outcome

Timeframe: 1 year post treatment

Population: Patients eligible and enrolled

One-year Kaplan-Meier estimate of survival, given in percent, with a 95% Confidence Interval based on the Greenwood variance, with log-log transform.

Outcome measures

Outcome measures
Measure	Arm I n=28 Participants Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Overall Survival	96.0 percentage of participants Interval 72.9 to 99.4

Adverse Events

Arm I

Serious events: 8 serious events

Other events: 28 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Arm I n=28 participants at risk Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Gastrointestinal disorders 10000081-Abdominal pain	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10028813-Nausea	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10016256-Fatigue	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10062501-Non-cardiac chest pain	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Infections and infestations 10023424-Kidney infection	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Infections and infestations 10040872-Skin infection	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Infections and infestations 10046571-Urinary tract infection	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10001675-Alkaline phosphatase increased	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10011368-Creatinine increased	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10025256-Lymphocyte count decreased	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10029366-Neutrophil count decreased	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10035528-Platelet count decreased	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10020949-Hypocalcemia	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Renal and urinary disorders 10069339-Acute kidney injury	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Vascular disorders 10020772-Hypertension	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.

Other adverse events

Other adverse events
Measure	Arm I n=28 participants at risk Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Musculoskeletal and connective tissue disorders Joint effusion with extensive nodular synovial proliferation	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) urothelial carcinoma	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Nervous system disorders 10013573-Dizziness	21.4% 6/28 • Number of events 6 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Nervous system disorders 10013911-Dysgeusia	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Nervous system disorders 10019211-Headache	21.4% 6/28 • Number of events 6 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Nervous system disorders 10024264-Lethargy	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Skin and subcutaneous tissue disorders 10037868-Rash maculo-papular	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Skin and subcutaneous tissue disorders 10040868-Skin hypopigmentation	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Skin and subcutaneous tissue disorders 10040947-Skin ulceration	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Skin and subcutaneous tissue disorders hand-foot syndrome symptoms	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Nervous system disorders 10033987-Paresthesia	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Nervous system disorders 10034620-Peripheral sensory neuropathy	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Nervous system disorders 10041349-Somnolence	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Nervous system disorders 10051272-Facial muscle weakness	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Nervous system disorders piriformis syndrome	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Psychiatric disorders 10002855-Anxiety	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Psychiatric disorders 10022437-Insomnia	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Renal and urinary disorders 10019450-Hematuria	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Renal and urinary disorders 10037032-Proteinuria	21.4% 6/28 • Number of events 6 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Renal and urinary disorders 10046539-Urinary frequency	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Renal and urinary disorders 10046555-Urinary retention	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Renal and urinary disorders 10046628-Urine discoloration	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Renal and urinary disorders 10061574-Urinary tract obstruction	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Renal and urinary disorders 10062225-Urinary tract pain	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Reproductive system and breast disorders 10034263-Pelvic pain	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Reproductive system and breast disorders 10046904-Vaginal dryness	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Reproductive system and breast disorders 10046916-Vaginal inflammation	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Respiratory, thoracic and mediastinal disorders 10011224-Cough	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Respiratory, thoracic and mediastinal disorders 10013963-Dyspnea	14.3% 4/28 • Number of events 4 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Respiratory, thoracic and mediastinal disorders 10028735-Nasal congestion	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Respiratory, thoracic and mediastinal disorders 10036790-Productive cough	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Respiratory, thoracic and mediastinal disorders 10041367-Sore throat	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Respiratory, thoracic and mediastinal disorders 10047681-Voice alteration	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Skin and subcutaneous tissue disorders hand-foot syndrome	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Skin and subcutaneous tissue disorders 10001760-Alopecia	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Skin and subcutaneous tissue disorders 10013786-Dry skin	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Skin and subcutaneous tissue disorders 10015218-Erythema multiforme	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Skin and subcutaneous tissue disorders 10037087-Pruritus	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Blood and lymphatic system disorders 10002272-Anemia	39.3% 11/28 • Number of events 11 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Cardiac disorders 10033557-Palpitations	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Cardiac disorders 10034474-Pericardial effusion	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Cardiac disorders 10040741-Sinus bradycardia	14.3% 4/28 • Number of events 4 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Cardiac disorders 10040752-Sinus tachycardia	25.0% 7/28 • Number of events 7 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Cardiac disorders aortic sclerosis w/o significant stenosis, mitral annular calcification	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Eye disorders 10005886-Blurred vision	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10000081-Abdominal pain	25.0% 7/28 • Number of events 7 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10002167-Anal pain	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10005265-Bloating	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10009887-Colitis	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10010774-Constipation	21.4% 6/28 • Number of events 6 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10012727-Diarrhea	57.1% 16/28 • Number of events 16 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10013781-Dry mouth	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10016766-Flatulence	14.3% 4/28 • Number of events 4 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10017853-Gastritis	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10019611-Hemorrhoids	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10028130-Mucositis oral	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10028813-Nausea	50.0% 14/28 • Number of events 14 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10031009-Oral pain	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10038062-Rectal fistula	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10038064-Rectal hemorrhage	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10038072-Rectal pain	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10042112-Stomach pain	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10047700-Vomiting	21.4% 6/28 • Number of events 6 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10054520-Oral dysesthesia	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Gastrointestinal disorders 10066874-Gastroesophageal reflux disease	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10008531-Chills	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10016256-Fatigue	57.1% 16/28 • Number of events 16 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10016558-Fever	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10016791-Flu like symptoms	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10017577-Gait disturbance	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10033371-Pain	32.1% 9/28 • Number of events 9 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10050068-Edema limbs	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10062466-Localized edema	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
General disorders 10062501-Non-cardiac chest pain	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Infections and infestations 10040753-Sinusitis	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Infections and infestations 10040872-Skin infection	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Infections and infestations 10046300-Upper respiratory infection	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Infections and infestations 10046571-Urinary tract infection	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Infections and infestations 10061229-Lung infection	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Infections and infestations bacterial infection	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Injury, poisoning and procedural complications 10016173-Fall	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10001551-Alanine aminotransferase increased	17.9% 5/28 • Number of events 5 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10001675-Alkaline phosphatase increased	39.3% 11/28 • Number of events 11 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10003481-Aspartate aminotransferase increased	35.7% 10/28 • Number of events 10 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10005364-Blood bilirubin increased	17.9% 5/28 • Number of events 5 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10008661-Cholesterol high	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10011368-Creatinine increased	57.1% 16/28 • Number of events 16 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10025256-Lymphocyte count decreased	35.7% 10/28 • Number of events 10 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10029366-Neutrophil count decreased	21.4% 6/28 • Number of events 6 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10035528-Platelet count decreased	46.4% 13/28 • Number of events 13 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10047896-Weight gain	17.9% 5/28 • Number of events 5 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10047900-Weight loss	57.1% 16/28 • Number of events 16 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10049182-White blood cell decreased	50.0% 14/28 • Number of events 14 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10055599-Hemoglobin increased	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Investigations 10056910-GGT increased	14.3% 4/28 • Number of events 4 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10002646-Anorexia	32.1% 9/28 • Number of events 9 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10012174-Dehydration	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10020587-Hypercalcemia	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10020639-Hyperglycemia	14.3% 4/28 • Number of events 4 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10020647-Hyperkalemia	35.7% 10/28 • Number of events 10 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10020670-Hypermagnesemia	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10020680-Hypernatremia	14.3% 4/28 • Number of events 4 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10020870-Hypertriglyceridemia	17.9% 5/28 • Number of events 5 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10020943-Hypoalbuminemia	50.0% 14/28 • Number of events 14 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10020949-Hypocalcemia	53.6% 15/28 • Number of events 15 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10021005-Hypoglycemia	35.7% 10/28 • Number of events 10 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10021018-Hypokalemia	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10021028-Hypomagnesemia	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10021038-Hyponatremia	60.7% 17/28 • Number of events 17 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10021059-Hypophosphatemia	14.3% 4/28 • Number of events 4 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Metabolism and nutrition disorders 10029883-Obesity	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10003239-Arthralgia	17.9% 5/28 • Number of events 5 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10003246-Arthritis	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10003988-Back pain	25.0% 7/28 • Number of events 7 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10006002-Bone pain	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10016750-Flank pain	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10028411-Myalgia	14.3% 4/28 • Number of events 4 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10028836-Neck pain	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10031282-Osteoporosis	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10033425-Pain in extremity	25.0% 7/28 • Number of events 7 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10048677-Buttock pain	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10048706-Joint range of motion decreased	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10062572-Generalized muscle weakness	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Musculoskeletal and connective tissue disorders 10065895-Muscle weakness upper limb	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Vascular disorders 10016825-Flushing	3.6% 1/28 • Number of events 1 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Vascular disorders 10020407-Hot flashes	7.1% 2/28 • Number of events 2 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Vascular disorders 10020772-Hypertension	89.3% 25/28 • Number of events 25 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.
Vascular disorders 10021097-Hypotension	10.7% 3/28 • Number of events 3 • 28-day time spans for each cycle. Cycles follow each other until the patient is off-study, up to one year.

Additional Information

Dr. Sumanta Pal

City of Hope

Phone: 626-359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place