Trial Outcomes & Findings for A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer (NCT NCT01799278)

Last Updated: 2018-01-23

Results Overview

Evaluated per RECIST 1.1 guidelines: Complete response (CR) is defined as complete disappearance of all measurable and evaluable lesions by physical examination or imaging studies and normalization of PSA with no appearance of new lesions for \> 1 month. Partial response (PR) is defined as a 30% 56 or greater reduction in the sum longest unidimensional diameter of all measurable lesions. There may be no new lesions. Stable Disease (SD) is characterized by patients who do not meet the criteria of PR and who are without signs of progressive disease for at least 1 month. Disease Progression (DP) is defined as a greater than 20% increase in the sum longest unidimensional diameters of the indicator lesions or the appearance of new lesions. Bone scan progression (evaluable disease only) is defined by PCWG2 criteria. Per consensus guidelines in CRPC, to be considered measurable, lymph nodes need to be at least 2 cm in greatest dimension and 1.5 cm in short axis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

one year

Results posted on

2018-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients MLN8237 at 50 mg twice daily for 7 days repeated every 21 days.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=60 Participants This is a single-arm, open-label Phase 2 trial evaluating MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer. Subjects will be treated with MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Individual dose reductions will be made on the basis of the AEs observed. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 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	2 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Outcome measures

Outcome measures
Measure	All Patients n=60 Participants MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent. MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.
Response Rate, as Assessed by CT/MRI and Bone Scan, of Treatment With MLN8237 for Patients With Neuroendocrine Prostate Cancer	18 participants

SECONDARY outcome

Timeframe: 3 years

Patients will be followed for survival endpoints following completion of this study until death.

Outcome measures

Outcome measures
Measure	All Patients n=60 Participants MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent. MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.
Progression-free Survival in Response to Therapy Castration-Resistant Prostate Cancer	2.2 months Interval 2.0 to 2.6
Progression-free Survival in Response to Therapy Neuroendocrine Prostate Cancer	2.3 months Interval 2.0 to 2.6
Progression-free Survival in Response to Therapy Castration-Resistant ProstateCancer-Adenocarcinoma	2.0 months Interval 2.0 to 2.6

SECONDARY outcome

Timeframe: 3 years

Patients will be followed for survival endpoints following completion of this study until death

Outcome measures

Outcome measures
Measure	All Patients n=60 Participants MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent. MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.
Overall Survival in Response to Therapy	9.5 months Interval 7.4 to 13.0

SECONDARY outcome

Timeframe: 2 years

Population: Data were not collected for this outcome.

PSA to be followed every cycle to determine response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data were not collected for this outcome.

CTC counts by CellSearch will be performed at baseline, at 4-6 weeks, and upon progression to determine response.

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 23 serious events

Other events: 60 other events

Deaths: 48 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=60 participants at risk MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent. MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.
Blood and lymphatic system disorders Neutropenia	1.7% 1/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Blood and lymphatic system disorders Febrile neutropenia	6.7% 4/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Blood and lymphatic system disorders Anemia	6.7% 4/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Blood and lymphatic system disorders Thrombocytopenia	5.0% 3/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
General disorders Fatigue	10.0% 6/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
General disorders Pain	1.7% 1/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Metabolism and nutrition disorders Electrolyte abnormalities	6.7% 4/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Renal and urinary disorders Infection (urinary tract, skin)	5.0% 3/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Metabolism and nutrition disorders Dehydration	5.0% 3/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Respiratory, thoracic and mediastinal disorders dyspnea	3.3% 2/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Renal and urinary disorders Hematuria	1.7% 1/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Renal and urinary disorders Acute kidney injury	1.7% 1/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Immune system disorders Rash	1.7% 1/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Nervous system disorders Neuropathy	1.7% 1/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Nervous system disorders Syncope	1.7% 1/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Nervous system disorders Intracranial hemorrhage	1.7% 1/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.

Other adverse events

Other adverse events
Measure	All Patients n=60 participants at risk MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent. MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.
General disorders Fatigue	78.3% 47/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Gastrointestinal disorders Anorexia	45.0% 27/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Gastrointestinal disorders nausea	38.3% 23/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
General disorders pain	38.3% 23/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Immune system disorders Dyspnea	26.7% 16/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Skin and subcutaneous tissue disorders Alopecia	26.7% 16/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Psychiatric disorders Depression	21.7% 13/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Renal and urinary disorders Urinary frequency	20.0% 12/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Gastrointestinal disorders Vomiting	18.3% 11/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Ear and labyrinth disorders Edema	18.3% 11/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Respiratory, thoracic and mediastinal disorders Cough	18.3% 11/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Renal and urinary disorders Hematuria	16.7% 10/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Ear and labyrinth disorders Dizziness	13.3% 8/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Renal and urinary disorders Urinary incontinence	13.3% 8/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Vascular disorders Hot flashes	13.3% 8/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Metabolism and nutrition disorders Dehydration	11.7% 7/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Gastrointestinal disorders Gastroesophageal reflux disease	11.7% 7/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
General disorders Fever	11.7% 7/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Investigations Creatinine increased	11.7% 7/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
General disorders Peripheral sensory neuropathy	11.7% 7/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.
Gastrointestinal disorders Mucositis oral	10.0% 6/60 • AEs which are serious must be reported to WCMC from first dose of MLN8237 up to and including 30 days after administration of the last dose of MLN8237. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a product whether or not it is related to the medicinal product. For this protocol an abnormal laboratory value will not be assessed as an AE unless that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.

Additional Information

Dr. Himisha Beltran

Weill Cornell Medical College

Phone: (646) 962-2072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place