Trial Outcomes & Findings for Cabergoline in Metastatic Breast Cancer (NCT NCT01730729)

Last Updated: 2019-09-17

Results Overview

Overall Response Rate (ORR) is defined as the number of patients that achieved Complete Response (CR) or Partial Response (PR) and will be assessed after 8 weeks (2 cycles) of therapy using CT scan images and RECIST guidelines. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

20 participants

Primary outcome timeframe

After 8 weeks (2 cycles) of treament

Results posted on

2019-09-17

Participant Flow

The study opened for accrual on November 29, 2012 with an accrual goal of up to 20 patients. The first patient starting treatment February 11, 2013. Accrual was suspended twice during the study; May 28 2014 reopening June 11, 2014 and July 24 2015, reopening August 27 2015. The study was closed October 21, 2015 with 20 patients enrolled.

Participant milestones

Participant milestones
Measure	Treatment (Cabergoline) Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Overall Study STARTED	20
Overall Study Completed 2 Cycles/Reached 1st Response	18
Overall Study Treated Cycle 3 and Beyond	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Cabergoline) Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Progressive Disease	12

Baseline Characteristics

Cabergoline in Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Cabergoline) n=20 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants
Sex: Female, Male Female	20 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	15 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	20 Participants n=99 Participants

PRIMARY outcome

Timeframe: After 8 weeks (2 cycles) of treament

Population: 2 patients did not reach 8 week response time point and were determined not to be evaluable for this objective.

Outcome measures

Outcome measures
Measure	Treatment (Cabergoline) n=18 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Overall Response Rate (ORR) at 2 Months	0 Participants

SECONDARY outcome

Timeframe: From start of treatment until progression of disease or death

Progression Free Survival (PFS) will be measured from time of treatment initiation until first documentation of progression of disease or death from any cause.

Outcome measures

Outcome measures
Measure	Treatment (Cabergoline) n=20 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Progression Free Survival (PFS)	1.84 Months Interval 1.84 to 3.68

SECONDARY outcome

Timeframe: After every 4 weeks (1 cycle) during treatment for up to 20 cycles and 30 days post last treatment

Toxicity will be assessed at the beginning of each cycle (1 cycle equals 28 days) during treatment and 30 days post last treatment during treatment. Toxicity will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE Grades 1 through 4 adverse events that were determined to be at least possibly related to treatment are combined and reported below.

Outcome measures

Outcome measures
Measure	Treatment (Cabergoline) n=20 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Treatment Toxicity Hyponatremia	3 participants
Treatment Toxicity Alkaline Phosphatase increased	3 participants
Treatment Toxicity Aspartate Aminotansferase increased	2 participants
Treatment Toxicity Hyperglycemia	2 participants
Treatment Toxicity Hypokalemia	2 participants
Treatment Toxicity Vomiting	1 participants
Treatment Toxicity Pain in extremity	1 participants
Treatment Toxicity Acute Kidney Injury	1 participants
Treatment Toxicity Alanine Aminotranserase increased	1 participants
Treatment Toxicity Diarrhea	1 participants
Treatment Toxicity Arthralgia	1 participants
Treatment Toxicity Creatinine increased	1 participants
Treatment Toxicity Hypocalcemia	1 participants
Treatment Toxicity Hypoglycemia	1 participants
Treatment Toxicity Insomnia	1 participants
Treatment Toxicity Pain	1 participants
Treatment Toxicity Dizziness	1 participants
Treatment Toxicity Dry eye	1 participants
Treatment Toxicity Hyperkalemia	1 participants
Treatment Toxicity Hypernatremia	1 participants
Treatment Toxicity Nausea	6 participants
Treatment Toxicity Fatigue	5 participants
Treatment Toxicity White Blood Cell decreased	1 participants

SECONDARY outcome

Timeframe: At baseline and at 8 weeks

Population: This data was not collected and analysed as it was decided that it was not meaningful on its own.

At baseline and after 2 cycles changes CT and bone scan measurements will be evaluated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and after 4 weeks (1 cycle)

Population: No data collected as no patients completed repeat biopsy after 1 cycle of treatment.

Evaluate prolactin expression in biopsy tissue taken at baseline and after 4 weeks (1 cycle) of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline

Population: Only 9 patients had sufficient baseline tissue to be analyzed.

Baseline tumor tissue was analyzed for prolactin receptor (PRLr) expression and was provided with an IHC-based Allred score of 0 to 300 based on percentage intensity where lower scores indicate less PRLr expression and high scores indicate more PRLr expression. Only the malignant epithelium was scored. The score was correlated with best response of patient.

Outcome measures

Outcome measures
Measure	Treatment (Cabergoline) n=9 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Correlate Tissue Prolactin Biomarkers With Response to Therapy Stable Disease	170 score on a scale Interval 110.0 to 220.0
Correlate Tissue Prolactin Biomarkers With Response to Therapy Progressive Disease	220 score on a scale Interval 120.0 to 250.0

SECONDARY outcome

Timeframe: From the start of treatment until death from any cause. Median follow up time of 6.817 months (95%CI 0.22-26.18)

Overall Survival (OS) is defined from the first day of treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Treatment (Cabergoline) n=20 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Overall Survival (OS)	10.41 Months Interval 7.06 to At the time of data collection cut off, not all patients were deceased and upper CI was not calculated.

POST_HOC outcome

Timeframe: After 8 weeks (2 cycles) of treatment

Population: 2 patients did not reach the 8 week response assessment time point.

Clinical Benefit Rate (CBR) is defined as the number of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and is assessed by RECIST guidelines for measurements of CT scan at 8 weeks (2 cycles) of treatment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started

Outcome measures

Outcome measures
Measure	Treatment (Cabergoline) n=18 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Clinical Benefit Rate (CBR) After 2 Cycles of Treatment	6 Participants

POST_HOC outcome

Timeframe: At 12 months from start of treatment

Number of patients without progressive disease as assessed by CT scan and RECIST guidelines at 12 months of treatment.

Outcome measures

Outcome measures
Measure	Treatment (Cabergoline) n=20 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Disease Control at 12 Months	2 Participants

POST_HOC outcome

Timeframe: From the start of treatment until the end of treatment up to a maximum of 20 cycles (1 cycle = 4 weeks)

Population: 1 patient died on treatment 7 days after starting and was not included in this outcome measure.

Best Overall Response is defined as patients best response to treatment from treatment initiation until the end of treatment as assessed by RECIST guidelines of CT scans. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started

Outcome measures

Outcome measures
Measure	Treatment (Cabergoline) n=19 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Best Overall Response Partial Response	1 Participants
Best Overall Response Stable Disease	5 Participants
Best Overall Response Progressive Disease	13 Participants

POST_HOC outcome

Timeframe: At baseline and after 2 cycles of treatment where 1 cycle =4 weeks

Population: Serum prolactin at baseline and after 2 cycles of treatment were only available for 12 patients.

Serum prolactin measurements were taken at baseline and after completion of two cycles of treatment. The mean drop was calculated for all patients, and for patients with best response of Stable Disease and Progressive Disease.

Outcome measures

Outcome measures
Measure	Treatment (Cabergoline) n=12 Participants Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Change in Serum Prolactin Levels From Baseline and After 2 Cycles of Treatment All	-9.425 ng/ml Interval -36.7 to -0.5
Change in Serum Prolactin Levels From Baseline and After 2 Cycles of Treatment Stable Disease	-8.72 ng/ml Interval -11.5 to -5.5
Change in Serum Prolactin Levels From Baseline and After 2 Cycles of Treatment Progressive Disease	-9.93 ng/ml Interval -36.7 to -0.5

Adverse Events

Treatment (Cabergoline)

Serious events: 4 serious events

Other events: 20 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Cabergoline) n=20 participants at risk Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 2/20 • Number of events 3 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
General disorders Death NOS	5.0% 1/20 • Number of events 1 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
General disorders Pain	5.0% 1/20 • Number of events 1 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.

Other adverse events

Other adverse events
Measure	Treatment (Cabergoline) n=20 participants at risk Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cabergoline: Given orally
Blood and lymphatic system disorders Anemia (Hemoglobin decrease)	30.0% 6/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Cardiac disorders Sinus Tachycardia	10.0% 2/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Eye disorders Dry eye	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Gastrointestinal disorders Constipation	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Gastrointestinal disorders Oral Mucositis	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Gastrointestinal disorders Nausea	30.0% 6/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Gastrointestinal disorders Stomach pain	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
General disorders Edema limbs	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
General disorders Fatigue	35.0% 7/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Alanine aminotransferase increased	10.0% 2/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Alkaline phosphatase increased	20.0% 4/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Aspartate aminotransferase increased	65.0% 13/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Blood prolactin abnormal	75.0% 15/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Cardiac troponin 1 increased	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Creatinine increased	10.0% 2/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations INR increased	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Lymphocyte Count decreased	50.0% 10/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Platelet Count decreased	10.0% 2/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Weight loss	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations White Blood Cell decreased	20.0% 4/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Metabolism and nutrition disorders Hyperglycemia	60.0% 12/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Metabolism and nutrition disorders Hyperkalemia	10.0% 2/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Metabolism and nutrition disorders Hypernatremia	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Metabolism and nutrition disorders Hypoalbuminemia	45.0% 9/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Metabolism and nutrition disorders Hypocalcemia	35.0% 7/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Metabolism and nutrition disorders Hypoglycemia	10.0% 2/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Metabolism and nutrition disorders Hypokalemia	15.0% 3/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Investigations Hyponatremia	25.0% 5/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Nervous system disorders Dizziness	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Nervous system disorders Headaches	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Psychiatric disorders Insomnia	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Psychiatric disorders Depression	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Renal and urinary disorders Acute Kidney Injury	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Skin and subcutaneous tissue disorders Erythema Multiforme	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Skin and subcutaneous tissue disorders Erythematous papules	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Vascular disorders Hypertension	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Vascular disorders Lymphedema	5.0% 1/20 • Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.

Additional Information

Cesar Santa-Maria, MD

Northwestern University

Phone: 312-695-6180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place