Trial Outcomes & Findings for Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer (NCT NCT00182689)

Last Updated: 2014-05-21

Results Overview

Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

89 participants

Primary outcome timeframe

8 weeks to 2 years

Results posted on

2014-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Platinum-Sensitive Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression \>90 days after the last platinum treatment.	Platinum-Refractory Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or \<=90 days after the last platinum treatment.
Overall Study STARTED	40	49
Overall Study Eligible	39	45
Overall Study Eligible and Began Protocol Therapy	38	45
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	40	49

Reasons for withdrawal

Reasons for withdrawal
Measure	Platinum-Sensitive Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression \>90 days after the last platinum treatment.	Platinum-Refractory Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or \<=90 days after the last platinum treatment.
Overall Study Adverse Event	8	11
Overall Study Withdrawal by Subject	2	2
Overall Study Progression	27	29
Overall Study Death	1	0
Overall Study not protocol specified	0	3
Overall Study Ineligible	1	4
Overall Study Never received treatment	1	0

Baseline Characteristics

Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Platinum-Sensitive n=38 Participants Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression \>90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.	Platinum-Refractory n=45 Participants Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or \<=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.	Total n=83 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	60 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	27 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	41 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sites of Metastases Single organ	4 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants
Sites of Metastases Multiple organs	32 participants n=5 Participants	34 participants n=7 Participants	66 participants n=5 Participants
Sites of Metastases None	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Sites of Metastases Not reported	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Performance Status 0	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Performance Status 1	22 participants n=5 Participants	29 participants n=7 Participants	51 participants n=5 Participants
Performance Status Not reported	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Smoking History Current	17 participants n=5 Participants	25 participants n=7 Participants	42 participants n=5 Participants
Smoking History Former	21 participants n=5 Participants	19 participants n=7 Participants	40 participants n=5 Participants
Smoking History Never	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Smoking History Not reported	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Weight Loss Prior 6 Months < 5%	26 participants n=5 Participants	31 participants n=7 Participants	57 participants n=5 Participants
Weight Loss Prior 6 Months 5% to < 10%	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Weight Loss Prior 6 Months 10% to < 20%	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Weight Loss Prior 6 Months > or = 20%	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Weight Loss Prior 6 Months Not reported	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks to 2 years

Population: All eligible patients who received treatment were included in this measure.

Outcome measures

Outcome measures
Measure	Platinum Sensitive n=38 Participants Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression \>90 days after the last platinum treatment.	Platinum Refractory n=45 Participants Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or \<=90 days after the last platinum treatment.
Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)	11 percentage of participants Interval 3.0 to 25.0	2 percentage of participants Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: Patients were assessed for adverse events after completion of every 28-day cycle.

Population: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Outcome measures

Outcome measures
Measure	Platinum Sensitive n=38 Participants Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression \>90 days after the last platinum treatment.	Platinum Refractory n=44 Participants Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or \<=90 days after the last platinum treatment.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dehydration	0 Participants with a given type of AE	2 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Diarrhea	0 Participants with a given type of AE	2 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dizziness	1 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dyspnea (shortness of breath)	3 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fatigue (asthenia, lethargy, malaise)	5 Participants with a given type of AE	3 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fever in absence of neutropenia, ANC lt1.0x10e9/L	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug AST, SGOT	1 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Allergic reaction/hypersensitivity	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Anorexia	2 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Ataxia (incoordination)	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Bilirubin (hyperbilirubinemia)	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Confusion	1 Participants with a given type of AE	2 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hemoglobin	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hypertension	3 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug INR (of prothrombin time)	1 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Inf w/normal ANC or Gr 1-2 neutrophils - Skin	1 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Inf w/normal ANC or Gr 1-2 neutrophils - UTI	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Lipase	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Muscle weakness, not d/t neuropathy - body/general	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Nausea	1 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Neuropathy: sensory	1 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug PTT (Partial thromboplastin time)	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pain - Abdomen NOS	1 Participants with a given type of AE	2 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pain - Extremity-limb	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pain - Joint	1 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pain-Other (Specify)	1 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pancreatitis	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Phosphate, serum-low (hypophosphatemia)	1 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pleural effusion (non-malignant)	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pneumonitis/pulmonary infiltrates	1 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Potassium, serum-low (hypokalemia)	1 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash/desquamation	1 Participants with a given type of AE	2 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash: acne/acneiform	2 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash: erythema multiforme	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash: hand-foot skin reaction	9 Participants with a given type of AE	8 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Sodium, serum-low (hyponatremia)	1 Participants with a given type of AE	2 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Speech impairment (e.g., dysphasia or aphasia)	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Syncope (fainting)	1 Participants with a given type of AE	0 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Vomiting	0 Participants with a given type of AE	1 Participants with a given type of AE
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Weight loss	0 Participants with a given type of AE	1 Participants with a given type of AE

SECONDARY outcome

Timeframe: 0 - 2 years

Measured from time of registration to death, or last contact date

Outcome measures

Outcome measures
Measure	Platinum Sensitive n=38 Participants Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression \>90 days after the last platinum treatment.	Platinum Refractory n=45 Participants Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or \<=90 days after the last platinum treatment.
Overall Survival	6.7 months Interval 6.1 to 9.1	5.3 months Interval 3.3 to 7.5

Adverse Events

Platinum Sensitive

Serious events: 6 serious events

Other events: 37 other events

Deaths: 0 deaths

Platinum Refractory

Serious events: 7 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Platinum Sensitive n=38 participants at risk	Platinum Refractory n=44 participants at risk
Gastrointestinal disorders Diarrhea	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Heartburn/dyspepsia	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Nausea	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Pain - Abdomen NOS	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Pancreatitis	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
General disorders Fatigue (asthenia, lethargy, malaise)	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Investigations Lipase	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Metabolism and nutrition disorders Dehydration	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	4.5% 2/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Musculoskeletal and connective tissue disorders Pain - Joint	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Ataxia (incoordination)	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Dizziness	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Neuropathy: motor	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Neuropathy: sensory	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Pain - Head/headache	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Syncope (fainting)	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Tremor	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Psychiatric disorders Confusion	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	4.5% 2/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	2.3% 1/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Vascular disorders Hypertension	2.6% 1/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.

Measure	Platinum Sensitive n=38 participants at risk	Platinum Refractory n=44 participants at risk
Blood and lymphatic system disorders Hemoglobin	18.4% 7/38 • Number of events 7 • Patients were assessed for adverse events after completion of every 28-day cycle.	22.7% 10/44 • Number of events 10 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Constipation	10.5% 4/38 • Number of events 4 • Patients were assessed for adverse events after completion of every 28-day cycle.	13.6% 6/44 • Number of events 6 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Diarrhea	21.1% 8/38 • Number of events 8 • Patients were assessed for adverse events after completion of every 28-day cycle.	34.1% 15/44 • Number of events 15 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Flatulence	10.5% 4/38 • Number of events 4 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Gastrointestinal-Other (Specify)	5.3% 2/38 • Number of events 2 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Heartburn/dyspepsia	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	6.8% 3/44 • Number of events 3 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	10.5% 4/38 • Number of events 4 • Patients were assessed for adverse events after completion of every 28-day cycle.	9.1% 4/44 • Number of events 4 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - Oral cavity	10.5% 4/38 • Number of events 4 • Patients were assessed for adverse events after completion of every 28-day cycle.	6.8% 3/44 • Number of events 3 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Nausea	34.2% 13/38 • Number of events 13 • Patients were assessed for adverse events after completion of every 28-day cycle.	22.7% 10/44 • Number of events 10 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Pain - Abdomen NOS	5.3% 2/38 • Number of events 2 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Gastrointestinal disorders Vomiting	18.4% 7/38 • Number of events 7 • Patients were assessed for adverse events after completion of every 28-day cycle.	15.9% 7/44 • Number of events 7 • Patients were assessed for adverse events after completion of every 28-day cycle.
General disorders Fatigue (asthenia, lethargy, malaise)	65.8% 25/38 • Number of events 25 • Patients were assessed for adverse events after completion of every 28-day cycle.	47.7% 21/44 • Number of events 21 • Patients were assessed for adverse events after completion of every 28-day cycle.
General disorders Pain-Other (Specify)	5.3% 2/38 • Number of events 2 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)	5.3% 2/38 • Number of events 2 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	10.5% 4/38 • Number of events 4 • Patients were assessed for adverse events after completion of every 28-day cycle.	13.6% 6/44 • Number of events 6 • Patients were assessed for adverse events after completion of every 28-day cycle.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	15.8% 6/38 • Number of events 6 • Patients were assessed for adverse events after completion of every 28-day cycle.	15.9% 7/44 • Number of events 7 • Patients were assessed for adverse events after completion of every 28-day cycle.
Investigations Alkaline phosphatase	10.5% 4/38 • Number of events 4 • Patients were assessed for adverse events after completion of every 28-day cycle.	18.2% 8/44 • Number of events 8 • Patients were assessed for adverse events after completion of every 28-day cycle.
Investigations Bilirubin (hyperbilirubinemia)	7.9% 3/38 • Number of events 3 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Investigations Leukocytes (total WBC)	5.3% 2/38 • Number of events 2 • Patients were assessed for adverse events after completion of every 28-day cycle.	15.9% 7/44 • Number of events 7 • Patients were assessed for adverse events after completion of every 28-day cycle.
Investigations Platelets	15.8% 6/38 • Number of events 6 • Patients were assessed for adverse events after completion of every 28-day cycle.	9.1% 4/44 • Number of events 4 • Patients were assessed for adverse events after completion of every 28-day cycle.
Investigations Weight loss	36.8% 14/38 • Number of events 14 • Patients were assessed for adverse events after completion of every 28-day cycle.	34.1% 15/44 • Number of events 15 • Patients were assessed for adverse events after completion of every 28-day cycle.
Metabolism and nutrition disorders Anorexia	47.4% 18/38 • Number of events 18 • Patients were assessed for adverse events after completion of every 28-day cycle.	38.6% 17/44 • Number of events 17 • Patients were assessed for adverse events after completion of every 28-day cycle.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	6.8% 3/44 • Number of events 3 • Patients were assessed for adverse events after completion of every 28-day cycle.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	6.8% 3/44 • Number of events 3 • Patients were assessed for adverse events after completion of every 28-day cycle.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	7.9% 3/38 • Number of events 3 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	7.9% 3/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue-Other (Specify)	5.3% 2/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	5.3% 2/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Musculoskeletal and connective tissue disorders Pain - Joint	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	11.4% 5/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Dizziness	5.3% 2/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	6.8% 3/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Neuropathy: sensory	21.1% 8/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Nervous system disorders Pain - Head/headache	7.9% 3/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	13.2% 5/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	15.9% 7/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other (Specify)	5.3% 2/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Skin and subcutaneous tissue disorders Dry skin	15.8% 6/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	31.8% 14/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	13.2% 5/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	9.1% 4/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Skin and subcutaneous tissue disorders Nail changes	7.9% 3/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Skin and subcutaneous tissue disorders Pruritus/itching	10.5% 4/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	18.2% 8/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Skin and subcutaneous tissue disorders Rash/desquamation	23.7% 9/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	22.7% 10/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	18.4% 7/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	13.6% 6/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Skin and subcutaneous tissue disorders Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)	0.00% 0/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	6.8% 3/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	47.4% 18/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	38.6% 17/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Vascular disorders Flushing	5.3% 2/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	0.00% 0/44 • Patients were assessed for adverse events after completion of every 28-day cycle.
Vascular disorders Hypertension	18.4% 7/38 • Patients were assessed for adverse events after completion of every 28-day cycle.	13.6% 6/44 • Patients were assessed for adverse events after completion of every 28-day cycle.