Trial Outcomes & Findings for Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer (NCT NCT00292045)
NCT ID: NCT00292045
Last Updated: 2023-10-04
Results Overview
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (fatal). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, and any other medically indicated assessments, including patient interviews, from the first dose of study treatment through the final follow-up visit. AEs were considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Up to 56 weeks
Results posted on
2023-10-04
Participant Flow
Participant milestones
| Measure |
NY-ESO-1 Protein + CpG 7909
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
|
|---|---|
|
Core Study (Through Week 13)
STARTED
|
15
|
|
Core Study (Through Week 13)
COMPLETED
|
13
|
|
Core Study (Through Week 13)
NOT COMPLETED
|
2
|
|
Extended Treatment Beyond Week 13
STARTED
|
10
|
|
Extended Treatment Beyond Week 13
COMPLETED
|
10
|
|
Extended Treatment Beyond Week 13
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
NY-ESO-1 Protein + CpG 7909
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
|
|---|---|
|
Core Study (Through Week 13)
Adverse Event
|
1
|
|
Core Study (Through Week 13)
Withdrawal by Subject
|
1
|
Baseline Characteristics
Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
NY-ESO-1 Protein + CpG 7909
n=15 Participants
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 56 weeksPopulation: The population comprises all patients who received any dose of study treatment.
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (fatal). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, and any other medically indicated assessments, including patient interviews, from the first dose of study treatment through the final follow-up visit. AEs were considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.
Outcome measures
| Measure |
NY-ESO-1 Protein + CpG 7909
n=15 Participants
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
|
|---|---|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Maximum TEAE severity Grade 1
|
2 Participants
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Serious TEAE
|
4 Participants
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
15 Participants
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Maximum TEAE severity Grade 2
|
10 Participants
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Maximum TEAE severity Grade 3
|
2 Participants
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Maximum TEAE severity Grade 4
|
1 Participants
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
TEAE leading to discontinuation
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 28 weeksPopulation: The population comprises all patients who received at least 4 vaccinations with study treatment.
Assays to assess cluster of differentiation (CD)4+ and CD8+ antigen-specific responses were performed at baseline (within 14 days prior to the first vaccination) and during the vaccination period (Weeks 4, 10, 16, 22, and 28) by enzyme-linked immune absorbent spot (ELISPOT) assay. A positive response was considered if the number of spots in the peptide-exposed well was 2-fold or more higher than the number of spots in the unstimulated well, and if there was a minimum of 10 (after subtraction of background spots) peptide-specific spots/25.000 T cells or less if T-cell clones were used.
Outcome measures
| Measure |
NY-ESO-1 Protein + CpG 7909
n=13 Participants
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
|
|---|---|
|
Number of Patients With Cellular Antibody Response to NY-ESO-1
CD4+ T cell response
|
9 Participants
|
|
Number of Patients With Cellular Antibody Response to NY-ESO-1
CD8+ T cell response
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 28 weeksPopulation: The population comprises all patients who received at least 4 vaccinations with study treatment.
Assays to assess NY-ESO-1 specific antibodies were performed at baseline (within 14 days prior to the first vaccination) and during the vaccination period (Weeks 4, 7, 10, 13, 16, 19, 22, 25, and 28). Sera were assessed over a range of dilutions from 1:100 to 1:400,000. Vaccine-induced antibodies were mapped with a panel of overlapping 20 mer peptides (25 μg/mL) spanning the whole protein sequence by enzyme-linked immunosorbent assay (ELISA). Immunoglobulin (Ig) subclasses G1 and G3 were determined by Western blot analysis using secondary antibody mouse anti-human IgG1/IgG3 at a dilution of 1:1000.
Outcome measures
| Measure |
NY-ESO-1 Protein + CpG 7909
n=13 Participants
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
|
|---|---|
|
Number of Patients With Humoral Antibody Response to NY-ESO-1
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 32 weeksPopulation: The population comprises all patients who received at least 4 vaccinations with study treatment.
Appropriate imaging scans were performed at baseline (within 14 days prior to the first vaccination) and during the vaccination period (Weeks 13 and 28). Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). 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.
Outcome measures
| Measure |
NY-ESO-1 Protein + CpG 7909
n=13 Participants
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
|
|---|---|
|
Number of Patients With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Stable disease
|
8 Participants
|
|
Number of Patients With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive disease
|
3 Participants
|
|
Number of Patients With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
No evidence of disease at baseline and on study
|
2 Participants
|
Adverse Events
NY-ESO-1 Protein + CpG 7909
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NY-ESO-1 Protein + CpG 7909
n=15 participants at risk
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
|
|---|---|
|
Nervous system disorders
Paraplegia
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Renal and urinary disorders
Renal failure
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
Other adverse events
| Measure |
NY-ESO-1 Protein + CpG 7909
n=15 participants at risk
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
|
|---|---|
|
Cardiac disorders
Bradycardia
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Eye disorders
Accommodation disorder
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Eye disorders
Eye irritation
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Injection site erythema
|
86.7%
13/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Pyrexia
|
80.0%
12/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Influenza like illness
|
26.7%
4/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Chills
|
20.0%
3/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Injection site pain
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Injection site vesicles
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Asthenia
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Feeling cold
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Injection site necrosis
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
3/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Infections and infestations
Tooth infection
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Investigations
Weight decreased
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Investigations
C-reactive protein increased
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Investigations
Karnofsky scale worsened
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Investigations
Weight increased
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
3/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Nervous system disorders
Sciatica
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Psychiatric disorders
Sleep disorder
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Renal and urinary disorders
Dysuria
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Renal and urinary disorders
Nocturia
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Renal and urinary disorders
Pollakiuria
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Renal and urinary disorders
Bladder pain
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Vascular disorders
Hypotension
|
13.3%
2/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Vascular disorders
Hot flush
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: (212) 450-1539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60