Trial Outcomes & Findings for Lonafarnib in Metastatic Breast Cancer (NCT NCT00773474)
NCT ID: NCT00773474
Last Updated: 2016-02-18
Results Overview
To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
18 months
Results posted on
2016-02-18
Participant Flow
Participant milestones
| Measure |
Lonafarnib
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lonafarnib in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Lonafarnib
n=29 Participants
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 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
|
29 participants
n=5 Participants
|
|
Primary Tumor Diagnosis
Breast Carcinoma
|
14 participants
n=5 Participants
|
|
Primary Tumor Diagnosis
Ductal Breast Carcinoma
|
20 participants
n=5 Participants
|
|
Primary Tumor Diagnosis
Lobular Breast Carcinoma
|
1 participants
n=5 Participants
|
|
Primary Tumor Diagnosis
Other
|
1 participants
n=5 Participants
|
|
Estrogen Receptor (ER)/Progesterone Receptor (PR)/ HER2 Status
ER-
|
9 participants
n=5 Participants
|
|
Estrogen Receptor (ER)/Progesterone Receptor (PR)/ HER2 Status
ER+
|
15 participants
n=5 Participants
|
|
Estrogen Receptor (ER)/Progesterone Receptor (PR)/ HER2 Status
PR-
|
13 participants
n=5 Participants
|
|
Estrogen Receptor (ER)/Progesterone Receptor (PR)/ HER2 Status
PR+
|
11 participants
n=5 Participants
|
|
Estrogen Receptor (ER)/Progesterone Receptor (PR)/ HER2 Status
HER2-
|
17 participants
n=5 Participants
|
|
Estrogen Receptor (ER)/Progesterone Receptor (PR)/ HER2 Status
HER2+
|
3 participants
n=5 Participants
|
|
Estrogen Receptor (ER)/Progesterone Receptor (PR)/ HER2 Status
Unknown
|
4 participants
n=5 Participants
|
|
Number of Prior Therapies
|
8.4 Prior Therapies
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: 20 participants were eligible for analysis via the Kaplan-Meier method. PFS assessed via RECIST criteria.
To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.
Outcome measures
| Measure |
Lonafarnib
n=20 Participants
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
|
|---|---|
|
Progression Free Survival
|
65.5 days
Interval 60.0 to 125.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 17 participants were evaluable for Overall Response Rate analysis using RECIST criteria.
To determine overall response rate.
Outcome measures
| Measure |
Lonafarnib
n=17 Participants
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
|
|---|---|
|
Overall Response Rate
CR
|
0 participants
|
|
Overall Response Rate
PR
|
0 participants
|
|
Overall Response Rate
SD
|
5 participants
|
|
Overall Response Rate
PD
|
12 participants
|
SECONDARY outcome
Timeframe: 18 monthsTo determine the toxicity profile of lonafarnib in this patient population.
Outcome measures
| Measure |
Lonafarnib
n=29 Participants
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
|
|---|---|
|
Toxicity Profile of Lonafarib
Grade 3/4 Diarrhea
|
6 participants
|
|
Toxicity Profile of Lonafarib
Grade 3/4 Dehydration
|
2 participants
|
|
Toxicity Profile of Lonafarib
Grade 5 Encephalopathy
|
1 participants
|
|
Toxicity Profile of Lonafarib
Disease Progression NOS
|
1 participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 20 evaluable subjects were analyzed for Clinical Benefit Rate (CR+PR+SD\>180 days per RECIST criteria.
Outcome measures
| Measure |
Lonafarnib
n=20 Participants
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
|
|---|---|
|
Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).
|
0 participants
|
Adverse Events
Lonafarnib
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lonafarnib
n=29 participants at risk
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
|
|---|---|
|
Nervous system disorders
ATAXIA (INCOORDINATION)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
DEATH NOT ASSOCIATED WITH CTCAE TERM / DISEASE PROGRESSION NOS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
DEHYDRATION
|
3.4%
1/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Nervous system disorders
ENCEPHALOPATHY
|
3.4%
1/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Hepatobiliary disorders
HEPATOBILIARY/PANCREAS - OTHER
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Psychiatric disorders
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
Other adverse events
| Measure |
Lonafarnib
n=29 participants at risk
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
|
|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
17.2%
5/29 • Number of events 7 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
ALKALINE PHOSPHATASE
|
17.2%
5/29 • Number of events 6 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY - OTHER
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
10.3%
3/29 • Number of events 4 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
ANOREXIA
|
58.6%
17/29 • Number of events 27 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
10.3%
3/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
27.6%
8/29 • Number of events 12 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
CHELITIS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Nervous system disorders
CONFUSION
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
CONSTIPATION
|
51.7%
15/29 • Number of events 17 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
37.9%
11/29 • Number of events 11 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
CREATININE
|
6.9%
2/29 • Number of events 6 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Renal and urinary disorders
CYSTITIS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
DEHYDRATION
|
10.3%
3/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Blood and lymphatic system disorders
DERMAL CHANGE LYMPHEDEMA, PHLEBOLYMPHEDEMA
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
DIARRHEA
|
75.9%
22/29 • Number of events 57 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Nervous system disorders
DIZZINESS
|
20.7%
6/29 • Number of events 8 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Eye disorders
DRY EYE SYNDROME
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
48.3%
14/29 • Number of events 16 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Eye disorders
EYELID DYSFUNCTION
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
86.2%
25/29 • Number of events 48 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
3.4%
1/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
FLATULENCE
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
FLU-LIKE SYNDROME
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
10.3%
3/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
6.9%
2/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
6.9%
2/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
10.3%
3/29 • Number of events 6 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
|
6.9%
2/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
GROWTH AND DEVELOPMENT - OTHER
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
20.7%
6/29 • Number of events 6 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
20.7%
6/29 • Number of events 7 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
27.6%
8/29 • Number of events 10 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
31.0%
9/29 • Number of events 9 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Cardiac disorders
HYPERTENSION
|
10.3%
3/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
INCONTINENCE, ANAL
|
3.4%
1/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Infections and infestations
INFECTIONWITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / SINUS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Infections and infestations
INFECTION - OTHER
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / WOUND
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
INSOMNIA
|
51.7%
15/29 • Number of events 18 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
6.9%
2/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
10.3%
3/29 • Number of events 5 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
34.5%
10/29 • Number of events 10 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
27.6%
8/29 • Number of events 8 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / STOMACH
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
13.8%
4/29 • Number of events 6 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER
|
3.4%
1/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
NAUSEA
|
62.1%
18/29 • Number of events 36 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Nervous system disorders
NEUROLOGY - OTHER
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
58.6%
17/29 • Number of events 17 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
OBESITY
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTION/STENOSIS OF AIRWAY / BRONCHUS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Eye disorders
OCULAR/VISUAL - OTHER
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
17.2%
5/29 • Number of events 6 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
PAIN / BACK
|
27.6%
8/29 • Number of events 9 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
10.3%
3/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Reproductive system and breast disorders
PAIN / BREAST
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
17.2%
5/29 • Number of events 5 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
24.1%
7/29 • Number of events 11 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
PAIN / HEAD/HEADACHE
|
20.7%
6/29 • Number of events 7 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
24.1%
7/29 • Number of events 13 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
PAIN / NECK
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
PAIN / PAIN NOS
|
10.3%
3/29 • Number of events 5 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
PAIN / PELVIS
|
10.3%
3/29 • Number of events 4 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
PAIN / STOMACH
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / THROAT/PHARYNX/LARYNX
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
PAIN / TUMOR PAIN
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
PAIN - OTHER
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Endocrine disorders
PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Blood and lymphatic system disorders
PLATELETS
|
13.8%
4/29 • Number of events 4 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Vascular disorders
PORTAL VEIN FLOW
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
13.8%
4/29 • Number of events 4 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Cardiac disorders
PROLONGED QTC INTERVAL
|
3.4%
1/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
24.1%
7/29 • Number of events 7 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
10.3%
3/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
10.3%
3/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
10.3%
3/29 • Number of events 3 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
RIGORS/CHILLS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
17.2%
5/29 • Number of events 9 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
SWEATING (DIAPHORESIS)
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
34.5%
10/29 • Number of events 12 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Endocrine disorders
THYROID FUNCTION, LOW (HYPOTHYROIDISM)
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Ear and labyrinth disorders
TINNITUS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Eye disorders
VISION-BLURRED VISION
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
6.9%
2/29 • Number of events 2 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
Gastrointestinal disorders
VOMITING
|
44.8%
13/29 • Number of events 20 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
WEIGHT GAIN
|
3.4%
1/29 • Number of events 1 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
|
General disorders
WEIGHT LOSS
|
10.3%
3/29 • Number of events 5 • Duration of Study, a maximum of seven cycles (Typically 21 days)
|
Additional Information
Principal Investigator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place