Trial Outcomes & Findings for Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC) (NCT NCT00084799)

NCT ID: NCT00084799

Last Updated: 2023-10-04

Results Overview

Gamma camera imaging, including planar scans and single-photon emission computed tomography (SPECT) scans, were carried out immediately following completion of infusion and on two subsequent occasions during the next 6 days after the infusions of 111In-hu3S193 on weeks 1 and 4. A pretreatment FDG-positron emission tomography PET/CT scan was performed within 2 weeks of study entry per standard clinical methods for comparison with gamma camera imaging. FDG-PET/ CT scans and 111In planar and SPECT scans were evaluated for extent of disease and antibody targeting, respectively. Lesions on FDG-PET/CT scans were considered positive if uptake of radiotracer was visually greater than surrounding tissue, with a standard uptake value greater than 3.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

28 days

Results posted on

2023-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	hu3S193 10 mg/m2 Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Overall Study STARTED	5	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	hu3S193 10 mg/m2 Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Overall Study Disease Progression	1	0

Baseline Characteristics

Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	hu3S193 10 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	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: 28 days

Population: Patients who received at least one dose of hu3S193.

Gamma camera imaging, including planar scans and single-photon emission computed tomography (SPECT) scans, were carried out immediately following completion of infusion and on two subsequent occasions during the next 6 days after the infusions of 111In-hu3S193 on weeks 1 and 4. A pretreatment FDG-positron emission tomography PET/CT scan was performed within 2 weeks of study entry per standard clinical methods for comparison with gamma camera imaging. FDG-PET/ CT scans and 111In planar and SPECT scans were evaluated for extent of disease and antibody targeting, respectively. Lesions on FDG-PET/CT scans were considered positive if uptake of radiotracer was visually greater than surrounding tissue, with a standard uptake value greater than 3.

Outcome measures

Outcome measures
Measure	hu3S193 10 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Confirmation of Tumor Targeting as Measured by the Number of Patients With Assessable Lesions Greater Than or Equal to 2 cm Measured by FDG-PET and SPECT Imaging.	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)

Population: Patients who received at least one dose of hu3S193.

Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.

Outcome measures

Outcome measures
Measure	hu3S193 10 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Mean Half-life (T1/2) as Measured by 111In-hu3S193 Radioactivity T½α	13.28 hours Standard Deviation 11.02	7.45 hours Standard Deviation 7.06
Mean Half-life (T1/2) as Measured by 111In-hu3S193 Radioactivity T½β	126.22 hours Standard Deviation 35.35	129.60 hours Standard Deviation 51.93

SECONDARY outcome

Timeframe: 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)

Population: Patients who received at least one dose of hu3S193.

Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.

Outcome measures

Outcome measures
Measure	hu3S193 10 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Mean Volume of Distribution of Central Compartment (V1) as Measured by 111In-hu3S193 Radioactivity	3040.78 mL Standard Deviation 565.38	3468.07 mL Standard Deviation 686.79

SECONDARY outcome

Timeframe: 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)

Population: Patients who received at least one dose of hu3S193.

Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.

Outcome measures

Outcome measures
Measure	hu3S193 10 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Mean Clearance (CL) as Measured by 111In-hu3S193 Radioactivity	28.83 mL/hour Standard Deviation 15.32	30.81 mL/hour Standard Deviation 10.18

SECONDARY outcome

Timeframe: 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)

Population: Patients who received at least one dose of hu3S193.

Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.

Outcome measures

Outcome measures
Measure	hu3S193 10 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Mean Area Under the Curve (AUC) as Measured by 111In-hu3S193 Radioactivity	859.97 hours*g/mL Standard Deviation 347.19	1327.00 hours*g/mL Standard Deviation 465.47

SECONDARY outcome

Timeframe: 4 weeks (pre-dose, weeks 1, 2, 3, and 4)

Population: Patients who received at least one dose of hu3S193.

Blood samples to measure human anti-human antibody (HAHA) assessments were obtained at baseline and each week before hu3S193 dosing. Measurement of immune responses to hu3S193 in patient blood samples was analyzed using a BIACORE (Piscataway, NJ) instrument using surface plasmon resonance (SPR).

Outcome measures

Outcome measures
Measure	hu3S193 10 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Immunogenicity of hu3S193 as Measured by the Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment With hu3S193. Number of Patients with HAHA	0 Participants	0 Participants
Immunogenicity of hu3S193 as Measured by the Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment With hu3S193. Number of Patients without HAHA	5 Participants	5 Participants

SECONDARY outcome

Timeframe: up to 28 days

Population: Patients who received at least one dose of hu3S193.

Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria (Therasse P et al. 2000).

Outcome measures

Outcome measures
Measure	hu3S193 10 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 Participants Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Number of Patients With Tumor Responses After Treatment With hu3S193 as Measured by RECIST CR	0 Participants	0 Participants
Number of Patients With Tumor Responses After Treatment With hu3S193 as Measured by RECIST PR	0 Participants	0 Participants
Number of Patients With Tumor Responses After Treatment With hu3S193 as Measured by RECIST SD	0 Participants	0 Participants
Number of Patients With Tumor Responses After Treatment With hu3S193 as Measured by RECIST PD	5 Participants	5 Participants

Adverse Events

hu3S193 10 mg/m2

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

hu3S193 20 mg/m2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	hu3S193 10 mg/m2 n=5 participants at risk Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 participants at risk Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).

Other adverse events

Other adverse events
Measure	hu3S193 10 mg/m2 n=5 participants at risk Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).	hu3S193 20 mg/m2 n=5 participants at risk Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
Investigations Blood creatinine	60.0% 3/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Investigations Hemoglobin	60.0% 3/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	100.0% 5/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Metabolism and nutrition disorders Hyperkalaemia	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Metabolism and nutrition disorders Hypoalbuminaemia	100.0% 5/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	80.0% 4/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Metabolism and nutrition disorders Hypokalaemia	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Metabolism and nutrition disorders Hyponatraemia	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Investigations International normalised ratio	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Gastrointestinal disorders Nausea	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Investigations Activated partial thromboplastin time	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Investigations Alanine aminotransferase	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Investigations Aspartate aminotransferase	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Investigations Blood alkaline phosphatase	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Investigations Blood creatine phosphokinase	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
General disorders Chest pain	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Gastrointestinal disorders Constipation	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Respiratory, thoracic and mediastinal disorders Cough	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Gastrointestinal disorders Dry mouth	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Respiratory, thoracic and mediastinal disorders Dyspnoea	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Skin and subcutaneous tissue disorders Skin exfoliation	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
General disorders Fatigue	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Nervous system disorders Headache	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Hepatobiliary disorders Hyperbillirubinemia	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Metabolism and nutrition disorders Hyperglycaemia	100.0% 5/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	100.0% 5/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Metabolism and nutrition disorders Hypernatraemia	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Vascular disorders Hypertension	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Blood and lymphatic system disorders Lymphopenia	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Investigations Platelet count	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Injury, poisoning and procedural complications Radiation skin injury	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Gastrointestinal disorders Vomiting	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	60.0% 3/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Investigations White blood cell count	0.00% 0/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	40.0% 2/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).
Metabolism and nutrition disorders Decreased appetite	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).	20.0% 1/5 • up to 8 weeks All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003).

Additional Information

Jonathan Skipper PhD

Ludwig Institute for Cancer Research

Phone: 12124501539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place