Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT00066729)

Last Updated: 2023-10-04

Results Overview

Toxicities and adverse events defined by National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT defined as: ≥ Grade 2 autoimmune phenomena, asymptomatic bronchospasm or generalized urticaria, or ≥ Grade 3 hematological and non hematological toxicities. To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

up to 16 weeks

Results posted on

2023-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Overall Study Lost to Follow-up	1
Overall Study Disease progression	1

Baseline Characteristics

Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 n=9 Participants Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	6 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 United States	9 participants n=5 Participants
NY-ESO-1 Tumor Expression Positive	4 Participants n=5 Participants
NY-ESO-1 Tumor Expression Negative	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 16 weeks

Population: All patients who entered the study and received treatment.

Outcome measures

Outcome measures
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 n=9 Participants Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Number of Patients With Dose Limiting Toxicities (DLTs)	0 Participants

SECONDARY outcome

Timeframe: up to 16 weeks

Population: All patients who entered the study and received treatment.

Blood samples were obtained at baseline and in weeks 4, 7, 10, 13 and 16 for the assessment of NY-ESO-1 specific antibodies by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 n=9 Participants Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Number of Patients Developing NY-ESO-1 Antibodies After Treatment Number of Patients with NY-ESO-1 Antibodies Before and After Treatment	2 Participants
Number of Patients Developing NY-ESO-1 Antibodies After Treatment Number of Patients with No NY-ESO-1 Antibodies Before and After Treatment	7 Participants

SECONDARY outcome

Timeframe: up to 16 weeks.

Population: All patients who entered the study and received treatment.

Blood samples were obtained at baseline and at 4, 7, 10. 13 and 16 weeks. Tetramer assays were conducted after presensitization of CD8+ T cells with NY-ESO-1b. Results are presented separately for patients with NY-ESO-1 positive and negative tumors.

Outcome measures

Outcome measures
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 n=9 Participants Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis Patients with NY ESO-1 Positive Tumors · CD8+ T cell immunity by positive tetramer	3 Participants
Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis Patients with NY ESO-1 Positive Tumors · No CD8+ T cell immunity by tetramer analysis	1 Participants
Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis Patients with NY-ESO-1 Negative Tumors · CD8+ T cell immunity by positive tetramer	3 Participants
Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis Patients with NY-ESO-1 Negative Tumors · No CD8+ T cell immunity by tetramer analysis	2 Participants

SECONDARY outcome

Timeframe: up to 16 weeks

Population: All patients who entered the study and received treatment.

Blood samples were obtained at baseline and at 4, 7, 10, 13 and 16 weeks. T cell responses were monitored after the in vitro sensitization with NY-ESO-1b (157-165), modified NY-ESO-1b-A (157-165A), or control peptide influenza matrix 58 to 66. Results are presented separately for patients with NY-ESO-1 positive and negative tumors.

Outcome measures

Outcome measures
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 n=9 Participants Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT Patients with NY-ESO-1 Positive Tumors · Number of patients with CD8+ T cell immunity	3 Participants
Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT Patients with NY-ESO-1 Positive Tumors · Number of patients without CD8+ T cell immunity	1 Participants
Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT Patients with NY-ESO-1 Negative Tumors · Number of patients with CD8+ T cell immunity	3 Participants
Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT Patients with NY-ESO-1 Negative Tumors · Number of patients without CD8+ T cell immunity	2 Participants

SECONDARY outcome

Timeframe: up to 16 weeks

Population: All patients who entered the study, received treatment and had at least 1 post-baseline DTH test.

NY-ESO-1b-specific delayed-type hypersensitivity (DTH) was measured by number of patients with induration and/or redness at each timepoint. NY-ESO-1b-specific DTH skin reaction was measured at baseline and weeks 7 and 16. The NY-ESO-1b peptide solution (0.1 mg/mL in 8% DMSO) was injected intradermally at a separate site from the vaccination to give a visable and palpable skin depot. The extent and intensity of DTH reactions were documented by measuring visible redness, palpable induration and other signs of local skin irritation or necrosis. Assessment of DTH reaction was performed 48 hours after injection, and the diameter of the reaction was documented.

Outcome measures

Outcome measures
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 n=9 Participants Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH) DTH Reaction	0 Participants
Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH) No DTH Reaction	9 Participants

POST_HOC outcome

Timeframe: up to 52 months

Population: All patients who entered the study and received treatment.

Although clinical outcome was not an endpoint of this study, patients were evaluated for disease progression throughout the study by cancer antigen 125 (CA-125) levels, physical examination and at the time of study completion with CT scan. All patients enrolled in the study were confirmed to be in Complete Response (cCR) at the initiation of therapy, as documented by CA-125 at \<35 units/mL, physical examination, and CT scan without evidence of disease. Patients were assessed for disease progression by CA-125 during the study at weeks 7 and 16. CT scan was done after completion of the study (week 16). After completion of the study, patients returned to the care of their primary treating oncologist, and monitoring was at the discretion of the treating physician. No evidence of disease (NED) was defined as no consistent increase in CA-125 or evidence of new lesions on CT scans. Progression was defined as the appearance of new lesions on CT scan.

Outcome measures

Outcome measures
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 n=9 Participants Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Clinical Outcome as Measured by Number of Patients With No Evidence of Disease and Number of Participants Who Progressed Week 16 (End of Study) · NED	7 Participants
Clinical Outcome as Measured by Number of Patients With No Evidence of Disease and Number of Participants Who Progressed Week 16 (End of Study) · Progression	2 Participants
Clinical Outcome as Measured by Number of Patients With No Evidence of Disease and Number of Participants Who Progressed Month 52 (last follow-up) · NED	3 Participants
Clinical Outcome as Measured by Number of Patients With No Evidence of Disease and Number of Participants Who Progressed Month 52 (last follow-up) · Progression	6 Participants

Adverse Events

NY-ESO-1b Peptide With Montanide® ISA-51

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NY-ESO-1b Peptide With Montanide® ISA-51 n=9 participants at risk Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
Investigations Alkaline phosphatase	22.2% 2/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Metabolism and nutrition disorders Hypoalbuminemia	66.7% 6/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Gastrointestinal disorders Abdominal hernia	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Investigations Alanine aminotransferase	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Investigations Blood bilirubin	33.3% 3/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Investigations Blood magnesium decreased	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Musculoskeletal and connective tissue disorders Bone pain	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Gastrointestinal disorders Breath odor	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
General disorders Catheter site erythema	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Nervous system disorders Confusional state	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Gastrointestinal disorders Constipation	44.4% 4/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Nervous system disorders Coordination abnormal	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Psychiatric disorders Depressed mood	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Cardiac disorders Dyspnea	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
General disorders Fatigue	55.6% 5/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Gastrointestinal disorders Gastroesophageal reflux disease	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Nervous system disorders Headache	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Investigations Hemoglobin	44.4% 4/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Reproductive system and breast disorders Hot flush	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Metabolism and nutrition disorders Hypercalcemia	55.6% 5/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Metabolism and nutrition disorders Hypoglycemia	22.2% 2/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Metabolism and nutrition disorders Hypothyroidism	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Musculoskeletal and connective tissue disorders Myalgia	22.2% 2/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Gastrointestinal disorders Nausea	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Nervous system disorders Neuropathy	44.4% 4/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Investigations Neutrophil count	55.6% 5/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Eye disorders Phootpsia	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Investigations Platelet count	22.2% 2/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Investigations Prothrombin time	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Skin and subcutaneous tissue disorders Skin exfloliation	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Cardiac disorders Syncope	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Gastrointestinal disorders Vomiting	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Investigations Weight increased	11.1% 1/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
Investigations White blood cell count	77.8% 7/9 • up to 16 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), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).

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