Trial Outcomes & Findings for sEphB4-HSA in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT04033432)

Last Updated: 2022-04-27

Results Overview

Assessment of confirmed PSA response rate is the proportion of subjects who received at least 1 dose of the study drug achieving a post-treatment PSA partial response or complete response as defined by PSA response criteria. PSA response criteria: These definitions are intended to characterize the PSA changes on study for the purpose of reporting of results. Complete Response (CR): Undetectable PSA (\<0.2 ng/ml) that is confirmed by another PSA level at no less than 4 weeks interval (+/- 3 days). Partial Response (PR): Decrease in PSA value by \> 50% that is confirmed by another PSA level at no less than 4 weeks interval (+/- 3 days). Stabilization(SD): Patients who do not meet the criteria or PR or PD for at least90 days on the study will be considered stable Progression (PD): 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by2 ng/ml that is confirmed by another PSA level at no less than 4 weeks interval.

Recruitment status

UNKNOWN

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2022-04-27

Participant Flow

The first patient started treatment on 10/01/2019. The study was designated to enroll patients s with mCRPC who have progressive disease despite castrate levels of testosterone (\<50 ng/dL) and have received at least one standard first-line therapy for metastatic castrate resistant prostate cancer, which can include therapy with a 2 nd generation AR targeted therapy (abiraterone or enzalutamide) or chemotherapy (docetaxel or cabazitaxel).The study was closed to further enrollment on 04/07/2021.

Participant milestones

Participant milestones
Measure	Treatment Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study. Recombinant EphB4-HSA Fusion Protein: Given IV
Overall Study STARTED	14
Overall Study Registered for Study	14
Overall Study Started Cycle 1	14
Overall Study Started Cycle 2	13
Overall Study Started Cycle 3	10
Overall Study Started Cycle 4	7
Overall Study Started Cycle 5	1
Overall Study Started Cycle 6	1
Overall Study Started Cycle 7+	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study. Recombinant EphB4-HSA Fusion Protein: Given IV
Overall Study Progressive Disease	8
Overall Study Adverse Event	4
Overall Study Death	1

Baseline Characteristics

sEphB4-HSA in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=14 Participants Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study. Recombinant EphB4-HSA Fusion Protein: Given IV
Age, Customized Age · 18-49	0 Participants n=5 Participants
Age, Customized Age · 50-59	2 Participants n=5 Participants
Age, Customized Age · 60-69	4 Participants n=5 Participants
Age, Customized Age · 70-79	6 Participants n=5 Participants
Age, Customized Age · 80-89	2 Participants n=5 Participants
Age, Customized Age · 90+	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: From the 14 patients whose PSA data was provided, 14 patients in the sample met the criteria to be assessed for PSA response.

Outcome measures

Outcome measures
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=14 Participants Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study. Recombinant EphB4-HSA Fusion Protein: Given IV
Prostate Specific Antigen (PSA) Response Rate Non-Evaluable	1 Participants
Prostate Specific Antigen (PSA) Response Rate Progressive Disease	13 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and reported by the toxicity, severity, and attribution will be recorded for each cycle. All reported adverse event (AE) types will be tabulated by maximum grade using frequencies and percentages. Data on type, timing, frequency and attribution of AEs will also be summarized.

Outcome measures

Outcome measures
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=14 Participants Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study. Recombinant EphB4-HSA Fusion Protein: Given IV
Incidence of Adverse Events	14 Participants

SECONDARY outcome

Timeframe: From the start of study treatment to PSA progression, assessed for up to 1 year

Population: Of the 14 eligible patients, 14 experienced disease progression by the end of their participation in the study, where progression included events as indicated by PSA values or with a known outcome of death by the time of follow-up. In accordance with the study protocol, a median value for days to progression. was calculated along with the 95% confidence interval.

The time to PSA progression will be assessed by calculating the interval from administration of the first dose of drug on cycle 1 day 1 to PSA progression. PSA progression is defined by the criteria. PSA will be assessed every odd cycle. Will use Kaplan Meier methods to estimate the distribution of time to PSA progression. Will estimate the median with two-sided 90% confidence interval (CI).

Outcome measures

Outcome measures
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=14 Participants Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study. Recombinant EphB4-HSA Fusion Protein: Given IV
Time to PSA Progression	28 Days Interval 28.0 to 64.0

SECONDARY outcome

Timeframe: Up to 1 year

Population: From the 14 patients whose RECIST data was provided, 3 patients in the sample met the criteria to be assessed for RECIST response (receive at least one dose of treatment, have measurable disease). Of the 3 eligible patients, 1 reported tumor progression as his best overall response while 2 patients experienced stabilization as their best overall response. No best overall responses were categorized as partial or complete drug response.

The overall response rate will be the proportion of patients with measurable disease who received at least 1 dose of the study drug and as their best response achieved a partial or complete response (responder). Will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and PCWG3 criteria. Will be reported with two-sided 90% exact binomial CI.

Outcome measures

Outcome measures
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=3 Participants Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study. Recombinant EphB4-HSA Fusion Protein: Given IV
Overall Response Rate Stable Disease	2 Participants
Overall Response Rate Progressive Disease	1 Participants

SECONDARY outcome

Timeframe: From the start of study treatment to the time of radiologic progression or death from any cause, assessed for up to 1 year

The time to rPFS will be assessed by calculating the interval from administration of the first dose of drug on cycle 1 day 1 to the time to radiologic progression by RECIST 1.1 or PCWG3 bone criteria or death from any cause. Radiologic assessment will be every 8 weeks. Will use Kaplan Meier methods to estimate the distribution of rPFS. Will estimate the median with two-sided 90% confidence interval (CI).

Outcome measures

Outcome measures
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=14 Participants Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study. Recombinant EphB4-HSA Fusion Protein: Given IV
Time to Radiologic Progression (rPFS)	55 Days Interval 55.0 to insufficient number of participants with events

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 1 year

EphB4 and ephrinB2 expression will be assessed by immunohistochemistry (IHC) staining of primary and/or metastatic site (recent archival specimen or new biopsy). EphB4 and other biomarker abnormalities will be assessed by next generation sequencing of metastatic tissue. Will explore if PSA response is associated with expression of EphB4 and ephrinB2 in archival metastatic and primary tumor CRPC specimens. Summaries will be descriptive and graphical.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 year

ctDNA will be analyzed for abnormalities in PI3K pathway, MYC or TP53. Summaries will be descriptive and graphical.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 year

The study will use IHC for CD3, CD4, CD8, and natural-killer cell markers to characterize the immune infiltrate in tumor specimen.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 3 serious events

Other events: 14 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=14 participants at risk Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient's condition, or the patient decides to withdraw from the study. Recombinant EphB4-HSA Fusion Protein: Given IV
Renal and urinary disorders Hematuria	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Cardiac troponin I increase	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Infections and infestations Urinary tract infection	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Nervous system disorders Transient ischemic attack	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Nervous system disorders Stroke	7.1% 1/14 • Number of events 2 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Injury, poisoning and procedural complications Infusion related reaction	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Psychiatric disorders Confusion	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Cardiac disorders Myocardial Infarction	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
General disorders Fatigue	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.

Other adverse events

Other adverse events
Measure	Treatment n=14 participants at risk Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient's condition, or the patient decides to withdraw from the study. Recombinant EphB4-HSA Fusion Protein: Given IV
Investigations Alanine aminotransferase increased	14.3% 2/14 • Number of events 2 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Alkaline phosphate increase	64.3% 9/14 • Number of events 12 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Immune system disorders Anaphylaxis	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Cardiac disorders Anemia	50.0% 7/14 • Number of events 11 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Metabolism and nutrition disorders Anorexia	21.4% 3/14 • Number of events 4 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Aspartate aminotransferase increased	50.0% 7/14 • Number of events 9 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Blood bicarbonate decrease	14.3% 2/14 • Number of events 2 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Blood bilirubin increase	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Eye disorders Blurred vision	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Musculoskeletal and connective tissue disorders Bone pain	14.3% 2/14 • Number of events 2 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Injury, poisoning and procedural complications Bruising	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Cardiac disorders Fusion Complexes (EKG)	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Gastrointestinal disorders Constipation	42.9% 6/14 • Number of events 6 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Creatinine increase	21.4% 3/14 • Number of events 5 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Gastrointestinal disorders Dental caries	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Gastrointestinal disorders Diarrhea	21.4% 3/14 • Number of events 4 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Nervous system disorders Dizziness	14.3% 2/14 • Number of events 2 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Skin and subcutaneous tissue disorders Dry skin	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Nervous system disorders Dysgeusia	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Electrocardiogram QT corrected interval prolonged	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
General disorders Fatigue	78.6% 11/14 • Number of events 13 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Gastrointestinal disorders Fecal incontinence	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Gastrointestinal disorders Flatulence	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
General disorders Gait disturbance	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Nervous system disorders Headache	14.3% 2/14 • Number of events 2 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Metabolism and nutrition disorders Hyperglycemia	85.7% 12/14 • Number of events 18 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Metabolism and nutrition disorders Hypernatremia	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Vascular disorders Hypertension	92.9% 13/14 • Number of events 36 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 7/14 • Number of events 9 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Metabolism and nutrition disorders Hypocalcemia	35.7% 5/14 • Number of events 10 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Metabolism and nutrition disorders Hyponatremia	42.9% 6/14 • Number of events 7 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Vascular disorders Hypotension	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Endocrine disorders Hypothyroidism	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Injury, poisoning and procedural complications Infusion related reaction	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Anion gap decrease	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
General disorders Localized edema	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Lymphocyte count decrease	64.3% 9/14 • Number of events 15 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
General disorders Malaise	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
General disorders Mucositis Oral	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Gastrointestinal disorders Mucositis oral	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Musculoskeletal and connective tissue disorders Muscle cramp	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Cardiac disorders Myocardial infarction	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
General disorders Pain	28.6% 4/14 • Number of events 4 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Eye disorders Periorbital edema	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations Platelet count decrease	35.7% 5/14 • Number of events 8 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Skin and subcutaneous tissue disorders Pruritus	21.4% 3/14 • Number of events 3 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Gastrointestinal disorders Rectal hemorrhage	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Renal and urinary disorders Pyuria	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Cardiac disorders Sinus bradycardia	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Cardiac disorders Sinus Tachyardia	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Infections and infestations Sinusitis	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Injury, poisoning and procedural complications Spinal fracture	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Nervous system disorders Stroke	7.1% 1/14 • Number of events 2 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Gastrointestinal disorders Toothache	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Nervous system disorders Transient ischemic attacks	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Renal and urinary disorders urinary frequency	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Renal and urinary disorders Urinary incontinence	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Infections and infestations Urinary tract infection	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Renal and urinary disorders Urinary tract obstruction	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Renal and urinary disorders Urinary urgency	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Skin and subcutaneous tissue disorders Urticaria	14.3% 2/14 • Number of events 2 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Ear and labyrinth disorders Vertigo	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Infections and infestations Weight loss	28.6% 4/14 • Number of events 6 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Investigations White blood cell decrease	28.6% 4/14 • Number of events 6 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.
Infections and infestations Wound infection	7.1% 1/14 • Number of events 1 • All events that occurred from the day the patient signs consent to within 30 days of the last dose of protocol treatment were reported accordingly. Any event that occurred more than 30 days after the last dose of treatment and is attributed (possibly, probably, or definitely) to the agent(s) must also be was also to be reported accordingly.

Additional Information

Maha Hussain, MD

Northwestern University

Phone: 312-908-5487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place