Trial Outcomes & Findings for Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer (NCT NCT00201760)

NCT ID: NCT00201760

Last Updated: 2017-12-27

Results Overview

Proportion of patients with metastatic breast cancer free of disease progression at 6 months following treatment

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2017-12-27

Participant Flow

Patients were enrolled in the study from February 2005 to March 2008

Participant milestones

Participant milestones
Measure	Arm 1 Gemcitabine/Cisplatin/Trastuzumab Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly. Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.	Arm 2 Gemcitabine / Trastuzumab Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 Gemcitabine/Cisplatin/Trastuzumab n=5 Participants Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly. Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.	Arm 2 Gemcitabine / Trastuzumab n=5 Participants Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.	Total n=10 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	42 years n=7 Participants	47.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Proportion of patients with metastatic breast cancer free of disease progression at 6 months following treatment

Outcome measures

Outcome measures
Measure	Arm 1 Gemcitabine/Cisplatin/Trastuzumab n=5 Participants Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly. Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.	Arm 2 Gemcitabine / Trastuzumab n=5 Participants Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
Disease Progression	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Response rate of the of the triple drug combination therapy and the double drug combination therapy regimens.

Outcome measures

Outcome measures
Measure	Arm 1 Gemcitabine/Cisplatin/Trastuzumab n=5 Participants Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly. Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.	Arm 2 Gemcitabine / Trastuzumab n=5 Participants Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
Measure Response Rate of Each Drug Combination	1 patients	0 patients

SECONDARY outcome

Timeframe: Up to 24 months

Population: Grades 3 and Grade 4

Adverse Events will be graded in accordance with the CTCAE Version 3.0 Toxicity grading criteria

Outcome measures

Outcome measures
Measure	Arm 1 Gemcitabine/Cisplatin/Trastuzumab n=5 Participants Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly. Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.	Arm 2 Gemcitabine / Trastuzumab n=5 Participants Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations Leukocytes (total WBC)	2 patients	1 patients
Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations Neutrophils/granulocytes	2 patients	2 patients
Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations Platelets (Thrombocytopenia)	1 patients	0 patients
Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations Fatigue	1 patients	1 patients

Adverse Events

Arm 1 Gemcitabine/Cisplatin/Trastuzumab

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Arm 2 Gemcitabine / Trastuzumab

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 Gemcitabine/Cisplatin/Trastuzumab n=5 participants at risk Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly. Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.	Arm 2 Gemcitabine / Trastuzumab n=5 participants at risk Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
Infections and infestations Pneumonia	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	0.00% 0/5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Gastrointestinal disorders Nausea/vomiting/diarrhea	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	0.00% 0/5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.

Other adverse events

Additional Information

Kari Kendra, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-7956

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm 1 Gemcitabine/Cisplatin/Trastuzumab n=5 participants at risk Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly. Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.	Arm 2 Gemcitabine / Trastuzumab n=5 participants at risk Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
Blood and lymphatic system disorders Hemoglobin	80.0% 4/5 • Number of events 4 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Blood and lymphatic system disorders Leukocytes	80.0% 4/5 • Number of events 4 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	80.0% 4/5 • Number of events 4 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Blood and lymphatic system disorders Neutrophils	80.0% 4/5 • Number of events 4 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Blood and lymphatic system disorders Thrombocytopenia	80.0% 4/5 • Number of events 4 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Respiratory, thoracic and mediastinal disorders Rhinitis	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
General disorders Chills	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	0.00% 0/5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
General disorders Fatigue	100.0% 5/5 • Number of events 5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	80.0% 4/5 • Number of events 4 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
General disorders Fever	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	0.00% 0/5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Psychiatric disorders Insomnia	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	80.0% 4/5 • Number of events 4 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Investigations Weight loss	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	0.00% 0/5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Skin and subcutaneous tissue disorders Pruritis	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Vascular disorders Hot Flashes	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Gastrointestinal disorders Constipation	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	100.0% 5/5 • Number of events 5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Gastrointestinal disorders Diarrhea	80.0% 4/5 • Number of events 4 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Gastrointestinal disorders Dyspepsia	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Gastrointestinal disorders Nausea	100.0% 5/5 • Number of events 5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Gastrointestinal disorders Stomatitis	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Metabolism and nutrition disorders Elevated ALT	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Metabolism and nutrition disorders Elevated AST	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	80.0% 4/5 • Number of events 4 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Metabolism and nutrition disorders Hyperglycemia	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Metabolism and nutrition disorders Hypoalbuminemia	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Metabolism and nutrition disorders Hypocalcemia	20.0% 1/5 • Number of events 1 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Psychiatric disorders Mood alteration (depression)	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Gastrointestinal disorders Abdominal Pain	0.00% 0/5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Musculoskeletal and connective tissue disorders arthralgia	60.0% 3/5 • Number of events 3 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Nervous system disorders Headache	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Musculoskeletal and connective tissue disorders Hip pain	0.00% 0/5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Musculoskeletal and connective tissue disorders Myalgia	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Respiratory, thoracic and mediastinal disorders Dyspnea	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.
Respiratory, thoracic and mediastinal disorders Dyspnea on exertion	0.00% 0/5 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.	40.0% 2/5 • Number of events 2 Adverse Events were graded in accordance with the NCI CTC Version 3.0 Toxicity grading criteria.