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Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT00616941
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Interventions Biological: NY-ESO-1 OLP4
Biological: NY-ESO-1 OLP4 + Montanide
Biological: NY-ESO-1 OLP4 + Montanide + Poly-ICLC
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 overlapping peptides [OLP4]) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of 5% dextrose in water (D5W) and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 vegetable grade (VG) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and polyinosinic-polycytidylic acid – poly-L-lysine carboxymethylcellulose (poly-ICLC) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.

Period Title: Overall Study
Started 4 13 11
Completed 3 8 5
Not Completed 1 5 6
Reason Not Completed
Progressive Disease             1             2             1
Adverse Event             0             1             1
Subject Non-compliance             0             0             1
Unrelated Medical Illness/Complication             0             2             0
Vaccination Suspended             0             0             3
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Total
Hide Arm/Group Description

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.

Total of all reporting groups
Overall Number of Baseline Participants 4 13 11 28
Hide Baseline Analysis Population Description
All Enrolled Subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 13 participants 11 participants 28 participants
56.8  (10.7) 58.6  (7.7) 57.1  (9.5) 57.8  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 13 participants 11 participants 28 participants
Female
4
 100.0%
13
 100.0%
11
 100.0%
28
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 13 participants 11 participants 28 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
 100.0%
13
 100.0%
11
 100.0%
28
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 13 participants 11 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   9.1%
1
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
13
 100.0%
10
  90.9%
27
  96.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 13 participants 11 participants 28 participants
4
 100.0%
13
 100.0%
11
 100.0%
28
 100.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 4 participants 13 participants 11 participants 28 participants
23.6  (4.8) 29.1  (8.1) 26.5  (6.6) 27.3  (7.2)
1.Primary Outcome
Title Overview of Treatment-emergent Adverse Events (TEAEs)
Hide Description Analysis of TEAEs reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 3 weeks after the last dose of study treatment.
Time Frame Continuously for up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description:

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.

Overall Number of Participants Analyzed 4 13 11
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
3
  75.0%
13
 100.0%
11
 100.0%
Treatment-related TEAE
2
  50.0%
12
  92.3%
11
 100.0%
TEAE Leading to Discontinuation
0
   0.0%
3
  23.1%
1
   9.1%
Dose-limiting toxicity
0
   0.0%
1
   7.7%
0
   0.0%
Serious TEAE
0
   0.0%
1
   7.7%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline
Hide Description Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. Specific antibodies against NY-ESO-1 were measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame Screening and Weeks 4, 7, 10, 13, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description:

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.

Overall Number of Participants Analyzed 4 13 11
Measure Type: Count of Participants
Unit of Measure: Participants
Detectable IgG Antibody Titers: Pretreatment
1
  25.0%
0
   0.0%
1
   9.1%
Detectable IgG Antibody Titers: Week 4
1
  25.0%
0
   0.0%
1
   9.1%
Detectable IgG Antibody Titers: Week 7
1
  25.0%
0
   0.0%
7
  63.6%
Detectable IgG Antibody Titers: Week 10
1
  25.0%
4
  30.8%
8
  72.7%
Detectable IgG Antibody Titers: Week 13
1
  25.0%
4
  30.8%
8
  72.7%
Detectable IgG Antibody Titers: Week 16
1
  25.0%
6
  46.2%
8
  72.7%
3.Secondary Outcome
Title Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline
Hide Description Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. NY-ESO-1-specific CD8+ and CD4+ T-cell reactivity was measured by tetramer analysis (in human leukocyte antigen [HLA] 0201* patients). Interferon gamma (IFN-γ) release by T cells was measured by the enzyme-linked immunospot (ELISPOT) assay. A subject was considered to have experienced a T-cell response if IFN-γ spots were detectable (>50 spots) by ELISPOT of 50,000 CD8+ and CD4+ T cells following pre-sensitization with a pool of 20-mer OLP covering all of NY-ESO-1 and tested against Epstein-Barr virus-transformed B cells pulsed with 3 subpools of these peptides.
Time Frame Screening and Weeks 4, 7, 10, 13, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description:

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.

Overall Number of Participants Analyzed 4 13 11
Measure Type: Count of Participants
Unit of Measure: Participants
Any CD8 T-cell Response Post-Baseline
1
  25.0%
9
  69.2%
10
  90.9%
Any CD4 T-cell Response Post-Baseline
4
 100.0%
13
 100.0%
11
 100.0%
4.Secondary Outcome
Title Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16
Hide Description NY-ESO-1-specific DTH was measured by skin tests at Screening and again at Week 16. NY-ESO-1 OLP4 (40 µg in 0.1 mL D5W) was injected intradermally, with DTH reactions read 48 hours after injection.
Time Frame Screening and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description:

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.

Overall Number of Participants Analyzed 4 13 11
Measure Type: Count of Participants
Unit of Measure: Participants
Presence of Induration at Screening
0
   0.0%
0
   0.0%
0
   0.0%
Presence of Induration at Week 16
1
  25.0%
4
  30.8%
2
  18.2%
Presence of Redness at Screening
0
   0.0%
2
  15.4%
2
  18.2%
Presence of Redness at Week 16
0
   0.0%
6
  46.2%
4
  36.4%
5.Secondary Outcome
Title Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline
Hide Description Serum CA-125 was measured at Screening, Week 7, and Week 16. Stable CA-125 at baseline was < 35 U/mL (defined as CA-125 that had not doubled from the post chemotherapy nadir).
Time Frame Screening, Week 7, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy measurement performed.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description:

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.

Overall Number of Participants Analyzed 4 13 11
Mean (Standard Deviation)
Unit of Measure: U/mL
Screening 14.0  (12.7) 8.5  (5.3) 10.9  (4.4)
Week 7 29.5  (44.3) 13.8  (12.5) 21.3  (25.8)
Week 16 8.0  (1.0) 12.9  (9.7) 35.1  (66.0)
6.Secondary Outcome
Title Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline
Hide Description Radiographic imaging (computed tomography of the abdomen and pelvis) was obtained at Screening and every 2 months during the study, and at unscheduled time points if any clinical symptoms/examination findings warranted further evaluation or if serum CA-125 rose to > 70 U/mL (confirmed by repeat value). Subjects may have had more than 1 location of disease.
Time Frame Screening and every 2 months up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy assessment performed.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description:

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.

Overall Number of Participants Analyzed 4 13 11
Measure Type: Count of Participants
Unit of Measure: Participants
Screening: Evidence of Disease
0
   0.0%
0
   0.0%
0
   0.0%
Week 7: Evidence of Disease
1
  25.0%
0
   0.0%
1
   9.1%
Week 7: Disease Location - Regional Lymph Node
1
  25.0%
0
   0.0%
0
   0.0%
Week 7: Disease Location - Liver
0
   0.0%
0
   0.0%
1
   9.1%
Week 7: Disease Location - Other
0
   0.0%
0
   0.0%
1
   9.1%
Week 16: Evidence of Disease
0
   0.0%
4
  30.8%
1
   9.1%
Week 16: Disease Location - Local Recurrence
0
   0.0%
4
  30.8%
0
   0.0%
Week 16: Disease Location - Liver
0
   0.0%
1
   7.7%
1
   9.1%
Time Frame All AEs occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 16 weeks for each subject.
Adverse Event Reporting Description AE documentation included onset/resolution dates, severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 3.0), frequency, seriousness, related interventions, and outcome. In summaries, treatment-related AEs included those with a “possible”, “probable”, or “definite” relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
 
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.

1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.

All-Cause Mortality
Cohort 1 Cohort 2 Cohort 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/13 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 Cohort 2 Cohort 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   1/13 (7.69%)   0/11 (0.00%) 
Infections and infestations       
Pneumonia  1 [1]  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
[1]
Grade 3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2 Cohort 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)   13/13 (100.00%)   11/11 (100.00%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Neutropenia  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Ear and labyrinth disorders       
Tinnitus  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Eye disorders       
Visual acuity reduced  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Gastrointestinal disorders       
Nausea  1  0/4 (0.00%)  4/13 (30.77%)  1/11 (9.09%) 
Abdominal pain upper  1  0/4 (0.00%)  0/13 (0.00%)  2/11 (18.18%) 
Diarrhoea  1  0/4 (0.00%)  1/13 (7.69%)  1/11 (9.09%) 
Abdominal discomfort  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Abdominal pain  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Abdominal pain lower  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Constipation  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Gastrooesophageal reflux disease  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Vomiting  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
General disorders       
Injection site reaction  1  1/4 (25.00%)  7/13 (53.85%)  10/11 (90.91%) 
Fatigue  1  2/4 (50.00%)  6/13 (46.15%)  3/11 (27.27%) 
Injection site pain  1  0/4 (0.00%)  1/13 (7.69%)  3/11 (27.27%) 
Pyrexia  1  0/4 (0.00%)  1/13 (7.69%)  2/11 (18.18%) 
Influenza like illness  1  0/4 (0.00%)  2/13 (15.38%)  0/11 (0.00%) 
Hernia  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Injection site erythema  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Injection site pruritus  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Injection site rash  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Oedema  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Oedema peripheral  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Infections and infestations       
Upper respiratory tract infection  1  1/4 (25.00%)  3/13 (23.08%)  1/11 (9.09%) 
Urinary tract infection  1  0/4 (0.00%)  1/13 (7.69%)  3/11 (27.27%) 
Bronchitis  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Laryngitis  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Oral herpes  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  1  0/4 (0.00%)  2/13 (15.38%)  0/11 (0.00%) 
Joint sprain  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Muscle strain  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Investigations       
Blood potassium decreased  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Neutrophil count abnormal  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  0/4 (0.00%)  2/13 (15.38%)  2/11 (18.18%) 
Arthralgia  1  0/4 (0.00%)  1/13 (7.69%)  2/11 (18.18%) 
Back pain  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Muscle spasms  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Musculoskeletal pain  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Musculoskeletal stiffness  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Pain in extremity  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Nervous system disorders       
Headache  1  1/4 (25.00%)  1/13 (7.69%)  0/11 (0.00%) 
Neuropathy peripheral  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Psychiatric disorders       
Insomnia  1  1/4 (25.00%)  0/13 (0.00%)  1/11 (9.09%) 
Renal and urinary disorders       
Urinary incontinence  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Reproductive system and breast disorders       
Pelvic pain  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea exertional  1  0/4 (0.00%)  2/13 (15.38%)  0/11 (0.00%) 
Cough  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Dyspnoea  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Nasal congestion  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Productive cough  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Pulmonary congestion  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Sinus congestion  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Skin and subcutaneous tissue disorders       
Erythema  1  0/4 (0.00%)  1/13 (7.69%)  1/11 (9.09%) 
Dermatitis contact  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Panniculitis  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Rash  1  0/4 (0.00%)  1/13 (7.69%)  0/11 (0.00%) 
Skin nodule  1  0/4 (0.00%)  0/13 (0.00%)  1/11 (9.09%) 
Urticaria  1  1/4 (25.00%)  0/13 (0.00%)  0/11 (0.00%) 
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Macri, Director, Clinical Trials Management
Organization: Ludwig Institute for Cancer Research
Phone: (212) 450-1546
EMail: mmacri@licr.org
Layout table for additonal information
Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00616941     History of Changes
Other Study ID Numbers: LUD2006-001
MSKCC IRB# 07-152
First Submitted: February 4, 2008
First Posted: February 15, 2008
Results First Submitted: April 28, 2017
Results First Posted: July 27, 2018
Last Update Posted: July 27, 2018