Trial Outcomes & Findings for Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer (NCT NCT02066532)
NCT ID: NCT02066532
Last Updated: 2023-08-24
Results Overview
The maximum tolerated dose (MTD) combination is defined as the dose combination associated with a target probability of dose limiting toxicity (DLT) of 0.25. A dose-limiting toxicity is defined as the MTD with DLTs defined as any grade 3 non-hematologic toxicities despite maximal supportive care or any grade 4 hematologic toxicity. The MTD will be estimated using the time to event continual reassessment method (TITE-CRM). The TITE-CRM will use an empirical dose-toxicity model, with a sample size of 10. The dose-toxicity model is calibrated such that the method will eventually select a dose that yields between 16% and 34% DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Up to 15 weeks
Results posted on
2023-08-24
Participant Flow
Overall 32 participants enrolled. The first 10 enrolled participated in phase I. Nine of the ten participants enrolled during phase I continued to phase II. An additional 22 participants enrolled in phase II. Five did not meet eligibility criteria, resulting in 26 allocated to intervention.
Participant milestones
| Measure |
Ruxolitinib (25mg)/Trastuzumab
Ruxolitinib: 25 mg bid (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
Ruxolitinib (20mg)/ Trastuzumab
Ruxolitinib: 20 mg bid (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
Ruxolitinib (15 mg)/ Trastuzumab
Ruxolitinib: 15 mg bid (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
Ruxolitinib (10 mg)/ Trastuzumab
Ruxolitinib:10 mg bid, (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|---|---|---|
|
Phase I
STARTED
|
9
|
1
|
0
|
0
|
|
Phase I
COMPLETED
|
9
|
1
|
0
|
0
|
|
Phase I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase II
STARTED
|
27
|
0
|
0
|
0
|
|
Phase II
COMPLETED
|
26
|
0
|
0
|
0
|
|
Phase II
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ruxolitinib (25mg)/Trastuzumab
Ruxolitinib: 25 mg bid (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
Ruxolitinib (20mg)/ Trastuzumab
Ruxolitinib: 20 mg bid (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
Ruxolitinib (15 mg)/ Trastuzumab
Ruxolitinib: 15 mg bid (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
Ruxolitinib (10 mg)/ Trastuzumab
Ruxolitinib:10 mg bid, (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|---|---|---|
|
Phase II
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 and Phase 2: Ruxolitinib/Trastuzumab (25 mg)
n=26 Participants
Ruxolitinib: 25 mg bid (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|
|
Age, Continuous
|
56 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Indian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/other
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Hormone receptor positive
|
19 Participants
n=5 Participants
|
|
Hormone receptor negative
|
7 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Score 0
|
14 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Score 1
|
12 Participants
n=5 Participants
|
|
Metastatic at time of diagnosis
|
14 Participants
n=5 Participants
|
|
Post-menopausal
|
24 Participants
n=5 Participants
|
|
Prior systemic therapy
|
4.5 number of prior regimens
n=5 Participants
|
|
Prior pertuzumab
|
23 Participants
n=5 Participants
|
|
Prior ado-trastuzumab emtansine
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 15 weeksThe maximum tolerated dose (MTD) combination is defined as the dose combination associated with a target probability of dose limiting toxicity (DLT) of 0.25. A dose-limiting toxicity is defined as the MTD with DLTs defined as any grade 3 non-hematologic toxicities despite maximal supportive care or any grade 4 hematologic toxicity. The MTD will be estimated using the time to event continual reassessment method (TITE-CRM). The TITE-CRM will use an empirical dose-toxicity model, with a sample size of 10. The dose-toxicity model is calibrated such that the method will eventually select a dose that yields between 16% and 34% DLT.
Outcome measures
| Measure |
Ruxolitinib/Trastuzumab
n=10 Participants
Ruxolitinib: 25 mg bid, 20 mg bid, 15 mg bid, or 10 mg bid, (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|
|
Maximum Tolerated Dose of Ruxolitinib in Combination With Trastuzumab (Phase I)
|
25 milligrams
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Phase II participants
Progression free survival (PFS) will be measured every 3 cycles (9 weeks of treatment +/- 4 days). PFS will be defined as the time from patient registration until objective or disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Ruxolitinib/Trastuzumab
n=26 Participants
Ruxolitinib: 25 mg bid, 20 mg bid, 15 mg bid, or 10 mg bid, (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|
|
Progression Free Survival (PFS) (Phase II)
|
8.3 Weeks
Interval 7.1 to 13.9
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Phase II participants
Participants will be reviewed at 24 weeks to determine the objective response rate, which is defined as the number of participants with a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
Outcome measures
| Measure |
Ruxolitinib/Trastuzumab
n=26 Participants
Ruxolitinib: 25 mg bid, 20 mg bid, 15 mg bid, or 10 mg bid, (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|
|
Objective Response Rate (Phase II)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Phase II participants
All phase II participants were evaluated for toxicity from the time of their first treatment with the study drugs. The frequency of subjects experiencing toxicities will be tabulated using the Canter Therapies Evaluation Program (CTEP) Active Version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 4.0).
Outcome measures
| Measure |
Ruxolitinib/Trastuzumab
n=26 Participants
Ruxolitinib: 25 mg bid, 20 mg bid, 15 mg bid, or 10 mg bid, (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|
|
Number of Participants With Adverse Events (Phase II)
|
26 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Phase II participants
CBR defined as complete response, partial response, or stable disease for \>24 weeks in the phase II portion
Outcome measures
| Measure |
Ruxolitinib/Trastuzumab
n=26 Participants
Ruxolitinib: 25 mg bid, 20 mg bid, 15 mg bid, or 10 mg bid, (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|
|
Clinical Benefit Ratio (CBR) (Phase II)
|
4 participants
|
Adverse Events
Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg)
Serious events: 8 serious events
Other events: 26 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg)
n=26 participants at risk
Ruxolitinib: 25 mg bid on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Infections and infestations
Wound Infection
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Nervous System Disorder
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Cardiac disorders
Chest Pain
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Vascular disorders
Thromboembolic Event
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Seizure
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (including cysts and polyps)
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
Other adverse events
| Measure |
Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg)
n=26 participants at risk
Ruxolitinib: 25 mg bid on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Trastuzumab: 6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
|
|---|---|
|
General disorders
Pain in extremity
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, upper limb
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Anemia
|
53.8%
14/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Renal and urinary disorders
Urinary Incontinence
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Eye disorders
Eye Disorder
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increase
|
19.2%
5/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
15.4%
4/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Immune system disorders
Allergic rhinitis
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Ascites
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increase
|
30.8%
8/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Bloating
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
19.2%
5/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Eye disorders
Blurred vision
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
CD4 lymphocytes decrease
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Cardiac disorders
Chest pain- cardiac
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Chills
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Cholesterol high
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Confusion
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Cough
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Creatinine increase
|
15.4%
4/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Renal and urinary disorders
Cystitis noninfective
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Diarrhea
|
26.9%
7/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Dizziness
|
19.2%
5/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Eye disorders
Dry eye
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Dry mouth
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.1%
6/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Edema face
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Edema limbs
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Cardiac disorders
Ejection fraction decreased
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Epistaxis
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Fall
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Fatigue
|
38.5%
10/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Fever
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Flu like symptoms
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Gait disturbance
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders, other
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Gastroparesis
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Headache
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Cardiac disorders
Heart failure
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Hepatobiliary disorders
Hepatic pain
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Hoarseness
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Hot flashes
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Cardiac disorders
Hypertension
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Hypertriglyceridemia
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
15.4%
4/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Hypoxia
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Infections and infestations
Infections and infestations, other
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Infusion related reaction
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Insomnia
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Localized edema
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Infections and infestations
Lung infection
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Memory impairment
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Nausea
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Nervous system disorders - Other
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
38.5%
10/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Oral pain
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Pain
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Cardiac disorders
Palpitations
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Paresthesia
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
30.8%
8/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Reproductive system and breast disorders
Premature menopause
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Rectal mucositis
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Infections and infestations
Skin infection
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Sore throat
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Musculoskeletal and connective tissue disorders
Spasticity
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Toothache
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Nervous system disorders
Transient ischemic attacks
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Tumor pain
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Renal and urinary disorders
Urinary tract infection
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
3/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Weight gain
|
15.4%
4/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
Weight loss
|
7.7%
2/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
34.6%
9/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.8%
1/26 • Up to 6 years
As only one participant was included in the Phase 1: Ruxolitinib (20mg)/ Trastuzumab arm, they are not represented in the adverse event tables in an effort to protect their confidentiality.
|
Additional Information
Dawn Hershman, MD
Columbia University Irving Medical Center
Phone: 212-305-5098
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place