Trial Outcomes & Findings for ESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer (NCT NCT03456804)

Last Updated: 2023-07-14

Results Overview

PSA decline of \>= 50% (PSA50) from baseline using Prostate Cancer Working Group 3 (PCWG3) definition with point estimate and (1-sided Wilson type 90% lower) confidence interval (CI) estimates.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2023-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment ESK981 Patients receive pan-VEGFR/TIE2 (Vascular Endothelial Growth Factor Receptor/angopoeitin receptor2) tyrosine kinase inhibitor CEP-11981 PO QD for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981. ESK981: Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment ESK981 n=13 Participants Patients receive pan-VEGFR/TIE2 (Vascular Endothelial Growth Factor Receptor/angopoeitin receptor2) tyrosine kinase inhibitor CEP-11981 PO QD for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981. ESK981: Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer
Age, Continuous	71 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 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	4 Participants n=99 Participants
Race (NIH/OMB) White	9 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	13 participants n=99 Participants
Performance Status PS = 1	13 Participants n=99 Participants
Performance Status PS = 0	0 Participants n=99 Participants
Gleason Score Gleason Score 6	1 Participants n=99 Participants
Gleason Score Gleason Score 7	3 Participants n=99 Participants
Gleason Score Gleason Score 8~10	6 Participants n=99 Participants
Gleason Score Gleason Score unknown	3 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 1 year

PSA decline of \>= 50% (PSA50) from baseline using Prostate Cancer Working Group 3 (PCWG3) definition with point estimate and (1-sided Wilson type 90% lower) confidence interval (CI) estimates.

Outcome measures

Outcome measures
Measure	Treatment ESK981 n=13 Participants Patients receive pan-VEGFR/TIE2 (Vascular Endothelial Growth Factor Receptor/angopoeitin receptor2) tyrosine kinase inhibitor CEP-11981 PO QD for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981. ESK981: Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer
PSA Decline of >= 50% (PSA50) From Baseline	7.7 percentage of participants Interval 1.7 to 28.2

SECONDARY outcome

Timeframe: From start of PSA50 until PSA progression, assessed up to 1 year

Population: patients who achieved a 50% reduction in PSA from baseline

Will be summarized with the Kaplan-Meier (K-M) survivorship estimate. A graph of the K-M curve for RD will be generated along with the Hall-Wellner 90% confidence band, and a display of the number of patients at risk at several time points, below the X-axis. Summary statistics (6-month rate, 12-month rate, median, etc.) will be calculated from the K-M life table, each one with its respective 80% CI.

Outcome measures

Outcome measures
Measure	Treatment ESK981 n=1 Participants Patients receive pan-VEGFR/TIE2 (Vascular Endothelial Growth Factor Receptor/angopoeitin receptor2) tyrosine kinase inhibitor CEP-11981 PO QD for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981. ESK981: Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer
Duration of PSA Response (RD)	1.9 months

SECONDARY outcome

Timeframe: Date that a 25% or greater increase and an absolute increase of 2.0 ng/mL or more from the nadir is documented and confirmed by a second value obtained 3 or more weeks later, assessed up to 1 year

Will be summarized with the Kaplan-Meier (K-M) survivorship estimate. A graph of the K-M curve for PFS will be generated along with the Hall-Wellner 90% confidence band, and a display of the number of patients at risk at several time points, below the X-axis. Summary statistics (6-month rate, 12-month rate, median, etc.) will be calculated from the K-M life table, each one with its respective 80% CI.

Outcome measures

Outcome measures
Measure	Treatment ESK981 n=13 Participants Patients receive pan-VEGFR/TIE2 (Vascular Endothelial Growth Factor Receptor/angopoeitin receptor2) tyrosine kinase inhibitor CEP-11981 PO QD for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981. ESK981: Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer
PSA Progression Free Survival (PFS)	0.9 months Interval 0.2 to 1.9

SECONDARY outcome

Timeframe: From treatment start until the first documented occurrence of PSA50, assessed up to 1 year

Population: patients who achieved a 50% reduction in PSA from baseline

Will be used to summarize the time to PSA response. These descriptives will include sample size (N), median, mean, standard deviation (SD), interquartile range (IQR), minimum, and maximum.

Outcome measures

Outcome measures
Measure	Treatment ESK981 n=1 Participants Patients receive pan-VEGFR/TIE2 (Vascular Endothelial Growth Factor Receptor/angopoeitin receptor2) tyrosine kinase inhibitor CEP-11981 PO QD for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981. ESK981: Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer
Time to PSA Response	10.0 months

Adverse Events

Treatment ESK981

Serious events: 5 serious events

Other events: 13 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Treatment ESK981 n=13 participants at risk Patients receive pan-VEGFR/TIE2 (Vascular Endothelial Growth Factor Receptor/angopoeitin receptor2) tyrosine kinase inhibitor CEP-11981 PO QD for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981. ESK981: Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer
Investigations Alanine aminotransferase increased	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Investigations Aspartate aminotransferase increased	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Cardiac disorders Cardiac disorders - Other, specify	15.4% 2/13 • Number of events 2 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Metabolism and nutrition disorders Hyperglycemia	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Vascular disorders Hypertension	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Metabolism and nutrition disorders Hyponatremia	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Vascular disorders Hypotension	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Investigations Lymphocyte count decreased	7.7% 1/13 • Number of events 2 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Cardiac disorders Myocardial infarction	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Infections and infestations Skin infection	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.

Other adverse events

Other adverse events
Measure	Treatment ESK981 n=13 participants at risk Patients receive pan-VEGFR/TIE2 (Vascular Endothelial Growth Factor Receptor/angopoeitin receptor2) tyrosine kinase inhibitor CEP-11981 PO QD for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981. ESK981: Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer
Metabolism and nutrition disorders Anorexia	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Psychiatric disorders Anxiety	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Musculoskeletal and connective tissue disorders Back pain	30.8% 4/13 • Number of events 5 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Injury, poisoning and procedural complications Bruising	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Cardiac disorders Cardiac disorders - Other, specify	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
General disorders Chills	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Gastrointestinal disorders Constipation	15.4% 2/13 • Number of events 2 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Gastrointestinal disorders Diarrhea	15.4% 2/13 • Number of events 2 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Nervous system disorders Dizziness	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Eye disorders Eye disorders - Other, specify	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
General disorders Fatigue	30.8% 4/13 • Number of events 6 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	23.1% 3/13 • Number of events 3 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
General disorders General disorders and administration site condi	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Renal and urinary disorders Hematuria	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Respiratory, thoracic and mediastinal disorders Hoarseness	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Vascular disorders Hypertension	15.4% 2/13 • Number of events 2 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Metabolism and nutrition disorders Hyponatremia	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Vascular disorders Hypotension	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Psychiatric disorders Insomnia	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
General disorders Localized edema	15.4% 2/13 • Number of events 2 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Vascular disorders Lymphedema	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	15.4% 2/13 • Number of events 2 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Nervous system disorders Nervous system disorders - Other, specify	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
General disorders Non-cardiac chest pain	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
General disorders Pain	30.8% 4/13 • Number of events 5 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 2/13 • Number of events 3 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Reproductive system and breast disorders Pelvic pain	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Reproductive system and breast disorders Reproductive system and breast disorders - Othe	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Infections and infestations Sinusitis	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Renal and urinary disorders Urinary frequency	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Vascular disorders Vascular disorders - Other, specify	15.4% 2/13 • Number of events 2 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 1 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.
Investigations Weight loss	15.4% 2/13 • Number of events 2 • 2 years An adverse event for the purposes of this protocol is the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition occurring after signing the informed consent even if the event is not considered to be related to the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, related or not to the medicinal product.

Additional Information

Elisabeth Heath, M.D.

Karmanos Cancer Institute

Phone: 313-576-8717

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place