Trial Outcomes & Findings for Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer (NCT NCT02876302)

Last Updated: 2026-02-04

Results Overview

Biologic response to 7-day run-in phase treatment, defined as a change in phosphorylated STAT3 (pSTAT3) expression from moderate/high positive (pSTAT3-positive) in pre-run-in phase sample to negative or weakly positive/equivocal (pSTAT3-negative) in post-run-in samples. pSTAT3 status was determined by evaluating the percent positive cells and the strength of staining (weak vs. strong/moderate) in relation to positive and negative controls. A T-score was calculated based on percent-stained cells and intensity of staining and interpreted as follows: Scores 0-4 are negative/weakly positive (pStat3 negative) and 5-8 are moderate/high positive (pStat3 positive). Hence, pStat3 negative indicates a biologic response or a decrease in pSTAT3 levels.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

7 days

Results posted on

2026-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Ruxolitinib Alone First Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Run-In Treatment Phase STARTED	11	12
Run-In Treatment Phase COMPLETED	11	12
Run-In Treatment Phase NOT COMPLETED	0	0
Neoadjuvant Treatment Phase STARTED	11	12
Neoadjuvant Treatment Phase Treated with neoadjuvant paclitaxel Only	6	0
Neoadjuvant Treatment Phase Treated with neoadjuvant ruxolitinib and paclitaxel	5	12
Neoadjuvant Treatment Phase COMPLETED	11	12
Neoadjuvant Treatment Phase NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ruxolitinib Alone First n=11 Participants Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in treatment phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=12 Participants Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in treatment phase for 7 days.	Total n=23 Participants Total of all reporting groups
Age, Continuous Median Age, Window Phase	54 years n=25 Participants	47 years n=26 Participants	53 years n=51 Participants
Sex: Female, Male Female	11 Participants n=25 Participants	12 Participants n=26 Participants	23 Participants n=51 Participants
Sex: Female, Male Male	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race/Ethnicity, Customized White	10 Participants n=25 Participants	12 Participants n=26 Participants	22 Participants n=51 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=25 Participants	0 Participants n=26 Participants	1 Participants n=51 Participants
Race/Ethnicity, Customized Non-Hispanic	11 Participants n=25 Participants	12 Participants n=26 Participants	23 Participants n=51 Participants
Region of Enrollment United States	11 participants n=25 Participants	12 participants n=26 Participants	23 participants n=51 Participants
Clinical N stage Unknown	1 Participants n=25 Participants	0 Participants n=26 Participants	1 Participants n=51 Participants
Clinical N stage cN0	0 Participants n=25 Participants	1 Participants n=26 Participants	1 Participants n=51 Participants
Clinical N stage cN1	10 Participants n=25 Participants	5 Participants n=26 Participants	15 Participants n=51 Participants
Clinical N stage cN2	0 Participants n=25 Participants	2 Participants n=26 Participants	2 Participants n=51 Participants
Clinical N stage cN3	0 Participants n=25 Participants	4 Participants n=26 Participants	4 Participants n=51 Participants
M stage Unknown	1 Participants n=25 Participants	1 Participants n=26 Participants	2 Participants n=51 Participants
M stage M0	9 Participants n=25 Participants	11 Participants n=26 Participants	20 Participants n=51 Participants
M stage M1	1 Participants n=25 Participants	0 Participants n=26 Participants	1 Participants n=51 Participants

PRIMARY outcome

Timeframe: 7 days

Population: A total of 23 patients were enrolled across 4 centers from January 24, 2018, to February 5, 2021. During the window phase of the trial, 11 patients received 7 days of ruxolitinib and 12 received ruxolitinib plus paclitaxel. Among 23 patients, 20 had baseline biopsy samples stained.

Outcome measures

Outcome measures
Measure	Ruxolitinib Alone First n=11 Participants Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=12 Participants Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel pStat3 negative	2 Participants	3 Participants
Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel pStat3 positive	9 Participants	6 Participants
Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel Baseline pStat3 status not available	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 28 weeks

Population: Neoadjuvant treatment phase population including those who received single agent ruxolitinib during the window phase treatment and then proceeded to neoadjuvant therapy with daily ruxolitinib plus weekly paclitaxel for 12 weeks (n=5) and those patients who had received the combination of ruxolitinib plus paclitaxel during the window phase continued to receive it for a total of 12 weeks (n=12).

Pathologic Complete Response rate (pCR) is defined as the absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy.

Outcome measures

Outcome measures
Measure	Ruxolitinib Alone First n=6 Participants Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=17 Participants Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Pathologic Complete Response Rate (pCR) After Preoperative Therapy pCR in breast and lymph nodes - No	5 Participants	16 Participants
Pathologic Complete Response Rate (pCR) After Preoperative Therapy pCR in breast and lymph nodes - Yes	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 7 Days

Population: To assess global transcriptomic changes during treatment, RNA-seq was performed on paired pre- and post-run-in phase tumor biopsy samples (n=4 per run-in treatment group).

Change of STAT3 gene expression between pretreatment and post-ruxolitinib run-in (after 7 days of ruxolitinib alone or with one dose of weekly paclitaxel) biopsy specimens. RNA-seq was performed on a subset of tumor pairs (n=4 per run-in treatment group). Enrichment analysis for JAK-STAT and IL-6 Hallmark signatures obtained a Gene Set Variation Analysis (GSVA) enrichment score as a measure of STAT3 gene expression. The GSVA enrichment score is a continuous unitless measure that summarizes joint expression of multiple genes into a single value. A positive value indicates greater, and a negative value a lesser, enrichment of pathway signatures; thus a negative pre- to post-runin change in the value indicates a decrease in the STAT3 expression after the treatment, and a positive values indicates increase in STAT3 expression after treatment.

Outcome measures

Outcome measures
Measure	Ruxolitinib Alone First n=4 Tumor pairs Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=4 Tumor pairs Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Assess Change in STAT3 Gene Expression Following run-in Treatment	-0.06 GSVA enrichment score Standard Deviation 0.23	0.01 GSVA enrichment score Standard Deviation 0.15

SECONDARY outcome

Timeframe: 2 years

Population: Two patients whose disease progressed during neoadjuvant therapy did not have surgery; the other 21 patients proceeded to surgery and radiation therapy.

Disease-Free Survival (DFS) is defined as time of surgery, among the subset of patients who underwent surgery (n=21), until occurrence of recurrence, contralateral cancer, death attributable to any cause, second primary cancer other than breast. DFS was censored at date of last assessment.

Outcome measures

Outcome measures
Measure	Ruxolitinib Alone First n=6 Participants Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=15 Participants Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Determine Efficacy Defined as Disease-Free Survival (DFS) DFS event - yes	4 Participants	8 Participants
Determine Efficacy Defined as Disease-Free Survival (DFS) DFS event - no	2 Participants	7 Participants

SECONDARY outcome

Timeframe: 2 years

The endpoint is now more commonly known as event-free survival (EFS). Defined as time of treatment initiation until occurrence of recurrence, contralateral cancer, death attributable to any cause, second primary cancer other than breast or occurrence of progressive disease during preoperative therapy or treatment of disease that is not surgically resectable; otherwise censored at last disease follow-up.

Outcome measures

Outcome measures
Measure	Ruxolitinib Alone First n=6 Participants Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=17 Participants Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Determine Efficacy Defined as Time to Treatment Failure (TTF) EFS event - no	2 Participants	7 Participants
Determine Efficacy Defined as Time to Treatment Failure (TTF) EFS event - yes	4 Participants	10 Participants

SECONDARY outcome

Timeframe: 2 years

Overall survival (OS) is defined as time from surgery until death from any cause or from treatment initiation until death from any cause.

Outcome measures

Outcome measures
Measure	Ruxolitinib Alone First n=6 Participants Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=17 Participants Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Determine Efficacy Defined as Overall Survival (OS) OS event - yes	3 Participants	5 Participants
Determine Efficacy Defined as Overall Survival (OS) OS event - no	3 Participants	12 Participants

SECONDARY outcome

Timeframe: 28 weeks

Population: Subset (n=15, patients allocated to ruxolitinib plus paclitaxel given as neoadjuvant therapy) of the overall patient population allocated to ruxolitinib plus paclitaxel given as neoadjuvant therapy (n=17) who had tumor samples at both baseline and 28 wk timepoints.

Residual cancer burden (RCB) is a continuous variable (RCB0 through RCB-IV) derived from the primary tumor dimensions, cellularity of the tumor bed, and axillary nodal burden as described in Symmans et al, 2007; where RCB-0 equals pathologic complete response (pCR) and considered the best prognosis and RCB-IV is considered the worst prognosis.

Outcome measures

Outcome measures
Measure	Ruxolitinib Alone First n=6 Participants Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=17 Participants Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy RCB-0 (pCR)	1 Participants	1 Participants
Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy RCB-I	1 Participants	1 Participants
Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy RCB-II	0 Participants	2 Participants
Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy RCB-III	1 Participants	2 Participants
Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy RCB-IV	3 Participants	9 Participants
Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy No surgery due to disease progression during neoadjuvant therapy	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 28 weeks

Population: Subset (n=4, patients allocated to paclitaxel alone as neoadjuvant therapy; n=13, patients allocated to ruxolitinib plus paclitaxel given as neoadjuvant therapy) of the overall population allocated to neoadjuvant therapy (n=6; n=17, respectively) who had blood samples successfully assayed at both baseline and 28 wk timepoints.

Elevations in interleukin (IL-6) and C-reactive protein (CRP) have been associated with worse clinical outcomes in patients with breast cancer. To determine whether STAT3 pathways were changed in the treatment groups, enrichment of JAKSTAT3 or IL-6 pathway-related gene signatures in the post-window phase samples compared to pre-window phase samples was analyzed. Enrichment analysis for JAK-STAT and IL-6 hallmark signatures were calculated using gene set variation analysis (GSVA) package. Each hospital followed their institutional guidelines for CRP and IL-6 measurements.

Outcome measures

Outcome measures
Measure	Ruxolitinib Alone First n=4 Participants Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=13 Participants Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Changes in Interleukin 6 (IL-6) Plasma Levels During Treatment	0.3 picograms per milliliter Interval -0.1 to 4.0	1.6 picograms per milliliter Interval 0.5 to 3.3

SECONDARY outcome

Timeframe: 28 weeks

Population: Subset (n=4, patients allocated to paclitaxel alone as neoadjuvant therapy; n=14, patients allocated to ruxolitinib plus paclitaxel given as neoadjuvant therapy) of the overall population allocated to neoadjuvant therapy (n=6; n=17, respectively) who had blood samples successfully assayed at both baseline and 28 wk timepoints.

Systemic biologic responses to ruxolitinib were assessed using serum IL-6 and c-reactive protein (CRP) levels. CRP levels are associated with poor prognosis and increased inflammatory response. Therefore, CRP levels in combination with pSTAT3 staining, could potentially be used as a more reliable method to select patients who would benefit from ruxolitinib treatment. To further analyze the effect of ruxolitinib throughout treatment, serum for CRP assessment was collected from patients at pre-window phase, post-window-phase, following 12-week neoadjuvant paclitaxel with or without ruxolitinib and immediately before surgery (pre-surgery). Each hospital followed their institutional guidelines for CRP measurements.

Outcome measures

Outcome measures
Measure	Ruxolitinib Alone First n=4 Participants Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=14 Participants Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
Changes in C-reactive Protein (CRP) Plasma Levels During Treatment	-0.9 milligram per liter Interval -2.9 to 0.6	2.8 milligram per liter Interval -0.2 to 11.8

Adverse Events

Ruxolitinib Alone First

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Ruxolitinib Plus Paclitaxel First

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Paclitaxel Alone Given As Neoadjuvant Therapy

Serious events: 0 serious events

Other events: 6 other events

Deaths: 3 deaths

Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy

Serious events: 5 serious events

Other events: 17 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Ruxolitinib Alone First n=11 participants at risk Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days.	Ruxolitinib Plus Paclitaxel First n=12 participants at risk Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.	Paclitaxel Alone Given As Neoadjuvant Therapy n=6 participants at risk Ruxolitinib alone (15 mg or 20 mg orally, depending on initial platelet count) is given in the run-in phase for 7 days. After the window phase, patients (n=6) who received ruxolitinib alone proceeded to neoadjuvant therapy with paclitaxel alone (80 mg/m2) for 12 weeks.	Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy n=17 participants at risk After the run-in phase, patients (n=5) receiving single agent ruxolitinib (15 mg or 20 mg orally, depending on initial platelet count) twice daily for seven days, proceeded to neoadjuvant therapy with ruxolitinib plus paclitaxel for 12 weeks in addition to patients (n=12) who had received the combination of ruxolitinib plus paclitaxel (15 mg orally) twice daily for seven days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase, continued to receive the combination of ruxolitinib plus paclitaxel for a total of 12 weeks.
General disorders Fatigue	0.00% 0/11 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/12 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/6 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	5.9% 1/17 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Investigations Neutrophil count decreased	0.00% 0/11 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/12 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/6 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	17.6% 3/17 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/11 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/12 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/6 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	11.8% 2/17 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/11 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/12 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/6 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	5.9% 1/17 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Vascular disorders Thromboembolic event	0.00% 0/11 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/12 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/6 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	5.9% 1/17 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
General disorders Infusion related reaction	0.00% 0/11 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	16.7% 2/12 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/6 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.	0.00% 0/17 • Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.

Other adverse events

Additional Information

Dr. Filipa Lynce, MD, Principal Investigator

Dana-Farber Cancer Institute

Phone: 617-632-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place