Trial Outcomes & Findings for Dendritic Cell Vaccines + Dasatinib for Metastatic Melanoma (NCT NCT01876212)

NCT ID: NCT01876212

Last Updated: 2019-08-22

Results Overview

Immune Response is defined as improved peripheral blood CD8+ T cell responses against 3 or more peptide epitopes after active vaccination with Type I-polarized autologous dendritic cell (αDC1) vaccine incorporating 6 tumor blood vessel-associated antigen (TBVA)-derived peptides. The measure of Immune Response for this study is expressed as a proportion of responders: The number of HLA-A2+ melanoma patients with improved peripheral blood CD8+ T cell responses (responders) divided by the total number of evaluable patients.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: Up to 13 months
• Results posted on: 2019-08-22

Participant Flow

Participant milestones

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Overall Study STARTED	9	6
Overall Study COMPLETED	9	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dendritic Cell Vaccines + Dasatinib for Metastatic Melanoma

Baseline characteristics by cohort

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=9 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Total n=15 Participants Total of all reporting groups
Age, Continuous	67.2 years n=5 Participants	64.7 years n=7 Participants	66.2 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Stage of Disease Stage IIC	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Stage of Disease Stage IV	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Stage of Disease Not evaluable	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 13 months

Population: Patients that received at least one cycle of study treatment.

Immune Response is defined as improved peripheral blood CD8+ T cell responses against 3 or more peptide epitopes after active vaccination with Type I-polarized autologous dendritic cell (αDC1) vaccine incorporating 6 tumor blood vessel-associated antigen (TBVA)-derived peptides.

The measure of Immune Response for this study is expressed as a proportion of responders: The number of HLA-A2+ melanoma patients with improved peripheral blood CD8+ T cell responses (responders) divided by the total number of evaluable patients.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Immune Response Rate	0.29 proportion of participants Interval 0.04 to 0.71	0.67 proportion of participants Interval 0.22 to 0.96

SECONDARY outcome

Timeframe: Up to 13 months

Population: Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation.

The number of treated patients by best clinical response achieved (tumor measurements via radiologic evaluation) using RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Best Clinical Response Partial Response	0 Participants	4 Participants
Best Clinical Response Progressed Disease	4 Participants	2 Participants
Best Clinical Response Stable Disease	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 13 months

Population: Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation.

The proportion of evaluable patients that achieved either partial or complete responses. Calculation: The number of patients who experienced a Partial Response (PR) + the number of patients who experienced a Complete Response (CR) / total number of response-evaluable patients.

Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Objective Response Rate (ORR)	0 proportion of participants Interval 0.0 to 0.4096	0.6667 proportion of participants Interval 0.2228 to 0.9567

SECONDARY outcome

Timeframe: Up to 2 years

Population: Patients that received at least one dose of study treatment who experienced a treatment-related toxicity .

Number of participants and severity grades for treatment-relatedness scores of possibly, probably, or definitely.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=9 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Worst Grade of Any Toxicity Grade 4 Toxicity	0 Participants	1 Participants
Worst Grade of Any Toxicity Grade 5 Toxicity	1 Participants	0 Participants
Worst Grade of Any Toxicity No >Grade 2 Toxicity	1 Participants	0 Participants
Worst Grade of Any Toxicity Grade 2 Toxicity	1 Participants	2 Participants
Worst Grade of Any Toxicity Grade 3 Toxicity	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 15 months

Population: Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation.

The length of time after study treatment that a patient lives with disease but the disease does not progress. Patients were followed for 1 year after removal from study treatment or until death, whichever occurs first. Per RECIST 1.1, Progressive Disease is defined as a ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=9 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Progression-free Survival (PFS)	1.967 months Interval 1.9 to Upper bound of the CI not reached	7.867 months Interval 2.133 to Upper bound of the CI not reached

SECONDARY outcome

Timeframe: Up to 30 months

Population: All patients enrolled in the study.

The length of time from the start of study treatment, that patients remain alive.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=9 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Overall Survival (OS)	3.667 months Interval 2.967 to Upper bound of CI not reached.	17.83 months Interval 11.5 to Upper bound of CI not reached.

SECONDARY outcome

Timeframe: At baseline (prior to treatment)

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Circulating serum concentration (levels) of T cell-recruiting chemokine CXCL10/IP-10 analyzed via ELISA assay. Higher levels of T cell-recruiting chemokine CXCL10/IP-1 correlate with patients exhibiting objective clinical response immunotherapy.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
T Cell-recruiting Chemokine CXCL10/IP-10	296.68 pg/mL Interval 120.04 to 931.2	268.06 pg/mL Interval 123.58 to 466.9

SECONDARY outcome

Timeframe: At between 5 and 7 weeks, post treatment

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Circulating serum concentration (levels) of T cell-recruiting chemokine CXCL10/IP-10 analyzed via ELISA assay. Higher levels of T cell-recruiting chemokine CXCL10/IP-1 correlate with patients exhibiting objective clinical response immunotherapy.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
T Cell-recruiting Chemokine CXCL10/IP-10	501.43 pg/mL Interval 152.96 to 1889.6	194.96 pg/mL Interval 80.61 to 360.0

SECONDARY outcome

Timeframe: At baseline (prior to treatment)

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Percentage of Treg CD4FoxP3 suppressor cells in patients' peripheral blood. The accumulation of Treg CD4FoxP3 suppressor cell populations correlates with tumor progression (disease progression) and negative prognosis.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Treg CD4FoxP3 Suppressor Cells	6.67 percentage of cells Interval 3.72 to 9.05	8.04 percentage of cells Interval 2.16 to 17.0

SECONDARY outcome

Timeframe: At between 4 and 6 weeks, post treatment

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Percentage of Treg CD4FoxP3 suppressor cells in patients' peripheral blood. The accumulation of Treg CD4FoxP3 suppressor cell populations correlates with tumor progression (disease progression) and negative prognosis.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Treg CD4FoxP3 Suppressor Cells	8.06 percentage of cells Interval 4.21 to 16.9	6.27 percentage of cells Interval 0.417 to 14.2

SECONDARY outcome

Timeframe: At between 7 and 10 weeks, post treatment

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Percentage of Treg CD4FoxP3 suppressor cells in patients' peripheral blood. The accumulation of Treg CD4FoxP3 suppressor cell populations correlates with tumor progression (disease progression) and negative prognosis.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Treg CD4FoxP3 Suppressor Cells	7.38 percentage of cells Interval 3.78 to 14.1	6.6 percentage of cells Interval 0.282 to 20.5

SECONDARY outcome

Timeframe: At baseline (prior to treatment)

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Percentage of Monocytic Myeloid Derived Suppressor Cells (M-MDSC) present in patients' peripheral blood. The accumulation of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Monocytic Myeloid Derived Suppressor Cells (M-MDSC)	6.23 percentage of cells Interval 2.65 to 10.4	11.65 percentage of cells Interval 0.707 to 23.4

SECONDARY outcome

Timeframe: At between 4 and 6 weeks, post treatment

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Percentage of Monocytic Myeloid Derived Suppressor Cells (M-MDSC) present in patients' peripheral blood. The accumulation of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Monocytic Myeloid Derived Suppressor Cells (M-MDSC)	8.7 percentage of cells Interval 3.29 to 12.6	8.78 percentage of cells Interval 2.59 to 20.6

SECONDARY outcome

Timeframe: At between 7 and 10 weeks, post treatment

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Percentage of Monocytic Myeloid Derived Suppressor Cells (M-MDSC) present in patients' peripheral blood. The accumulation of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Monocytic Myeloid Derived Suppressor Cells (M-MDSC)	9.32 percentage of cells Interval 0.131 to 24.6	8.32 percentage of cells Interval 0.433 to 17.2

SECONDARY outcome

Timeframe: At baseline (prior to treatment)

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Percentage of Polymorphonucler myeloid-derived suppressor cells (PMN-MDSC) present in patients' peripheral blood. The accumulation/increase of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC)	12.36 percentage of cells Interval 5.02 to 20.1	11.59 percentage of cells Interval 1.24 to 23.0

SECONDARY outcome

Timeframe: At between 4 and 6 weeks, post treatment

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Percentage of Polymorphonucler myeloid-derived suppressor cells (PMN-MDSC) present in patients' peripheral blood. The accumulation/increase of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC)	10.14 percentage of cells Interval 3.39 to 14.4	14.61 percentage of cells Interval 0.865 to 49.7

SECONDARY outcome

Timeframe: At between 7 and 10 weeks, post treatment

Population: Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.

Percentage of Polymorphonucler myeloid-derived suppressor cells (PMN-MDSC) present in patients' peripheral blood. The accumulation/increase of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.

Outcome measures

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=7 Participants Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 Participants Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC)	9.41 percentage of cells Interval 2.46 to 23.5	12.45 percentage of cells Interval 1.08 to 26.7

SECONDARY outcome

Timeframe: Up to 6 months

Population: Results not achievable due to insufficient patient biopsy material for the assays required for this endpoint.

Level of EphA2 protein expression in tumor tissue biopsies.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: Results not achievable due to insufficient patient biopsy material for the assays required for this endpoint.

Percentage of suppressor cell populations and blood vessels in melanoma tumor biopsies.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: Results not achievable due to insufficient patient biopsy material for the assays required for this endpoint.

Percentage of CD8+ T cells infiltrating into melanoma lesions (tumor tissues).

Outcome measures

Outcome data not reported

Adverse Events

Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)

Serious events: 7 serious events

Other events: 8 other events

Deaths: 8 deaths

Vaccine + Dasatinib (Cycle 1, D1)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

Serious adverse events

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=9 participants at risk Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 participants at risk Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Endocrine disorders Adrenal insufficiency	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Abdominal pain	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Constipation	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Nausea	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Vomiting	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Fatigue	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Gait disturbance	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Non-cardiac chest pain	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Infections and infestations Urinary tract infection	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Investigations - Other, specify	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Lymphocyte count decreased	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Urine output decreased	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Anorexia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hyperuricemia	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Musculoskeletal and connective tissue disorders Back pain	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Nervous system disorders Encephalopathy	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Psychiatric disorders Confusion	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Hypoxia	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Vascular disorders Hypotension	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.

Other adverse events

Measure	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) n=9 participants at risk Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Vaccine + Dasatinib (Cycle 1, D1) n=6 participants at risk Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10\^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Blood and lymphatic system disorders Anemia	55.6% 5/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	50.0% 3/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Cardiac disorders Palpitations	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Cardiac disorders Sinus tachycardia	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Ear and labyrinth disorders Ear pain	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Endocrine disorders Hypoparathyroidism	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Endocrine disorders Hypothyroidism	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Eye disorders Eyelid function disorder	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Constipation	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	50.0% 3/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Dry mouth	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Dysphagia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Nausea	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	83.3% 5/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	66.7% 4/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Chills	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Edema limbs	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Fatigue	55.6% 5/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	83.3% 5/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Fever	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Malaise	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	50.0% 3/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Non-cardiac chest pain	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
General disorders Pain	33.3% 3/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Infections and infestations Eye infection	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Infections and infestations Lung infection	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Infections and infestations Lymph gland infection	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Infections and infestations Phlebitis infective	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Infections and infestations Skin infection	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Infections and infestations Upper respiratory infection	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Infections and infestations Urinary tract infection	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Injury, poisoning and procedural complications Bruising	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Alkaline phosphatase increased	33.3% 3/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Aspartate aminotransferase increased	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	50.0% 3/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Cardiac troponin I increased	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Creatinine increased	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Investigations - Other, specify	33.3% 3/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Lymphocyte count decreased	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	50.0% 3/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Neutrophil count decreased	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	66.7% 4/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Platelet count decreased	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	50.0% 3/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations Weight loss	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Investigations White blood cell decreased	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Anorexia	33.3% 3/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Dehydration	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hypoalbuminemia	44.4% 4/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	66.7% 4/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hypocalcemia	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hypokalemia	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hypomagnesemia	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hyponatremia	55.6% 5/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	83.3% 5/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Hypophosphatemia	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Musculoskeletal and connective tissue disorders Flank pain	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Musculoskeletal and connective tissue disorders Neck pain	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	50.0% 3/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Nervous system disorders Dizziness	33.3% 3/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Nervous system disorders Dysarthria	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Nervous system disorders Headache	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	66.7% 4/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Psychiatric disorders Hallucinations	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Psychiatric disorders Insomnia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	50.0% 3/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Renal and urinary disorders Acute kidney injury	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Renal and urinary disorders Bladder spasm	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Reproductive system and breast disorders Uterine hemorrhage	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Cough	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Skin and subcutaneous tissue disorders Erythema multiforme	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	50.0% 3/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	33.3% 2/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Vascular disorders Hot flashes	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Vascular disorders Hypertension	0.00% 0/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	16.7% 1/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Vascular disorders Lymphedema	11.1% 1/9 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.	0.00% 0/6 • Up to 3 years This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.

Additional Information

Barbara Stadterman, MPH MCCR

UPMC Hillman Cancer Center

Phone: 412-647-5554

Email: stadtermanbm@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place