Trial Outcomes & Findings for A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome (NCT NCT00830518)

Last Updated: 2018-05-11

Results Overview

Best ORR is defined as the number of participants with complete remission(CR) or partial remission(PR) assessed by the Investigator using modified AML/MDS International Working Group(IWG) Criteria. AML:CR=neutrophils \>1x10\^9/L, platelets \>100x10\^9/L, bone marrow blasts(BMB) \<5%, transfusion independent, no extramedullary disease(EMD); CRi=BMB \<5%, transfusion independent, no EMD; PR=neutrophils \>1x10\^9/L, platelets \>100x10\^9/L, BMB \>50% decrease and 5% to 25%, blasts \<5% with Auer rods; PRi=BMB \>50% decrease and 5% to 25%. MDS:CR=bone marrow: ≤5% myeloblasts with normal maturation, peripheral blood: hemoglobin ≥11 g/dL, platelets ≥100x10\^9/L, neutrophils ≥1.0x10\^9/L, blasts 0%; PR=all CR criteria if abnormal before treatment except: BMB decreased by ≥50% over pretreatment but still \>5%; PRi=BMB decreased by ≥50% over pretreatment but still \>5%; Marrow CR=bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment, peripheral blood hematologic improvement responses noted.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)

Results posted on

2018-05-11

Participant Flow

Participants took part in the study at 19 investigative sites in France, Canada and the United States from 10 February 2009 to 04 July 2011.

Participants with a diagnosis of acute myelogenous leukemia or myelodysplastic syndrome received 50 mg alisertib twice daily for 7 days in 21 day cycles. Results are reported according to lymphoma disease subtypes: acute myelogenous leukemia and myelodysplastic syndrome.

Participant milestones

Participant milestones
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
Overall Study STARTED	46	11
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	46	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
Overall Study Progressive Disease	18	8
Overall Study Symptomatic Deterioration	4	1
Overall Study Adverse Event	14	1
Overall Study Withdrawal by Patient	2	0
Overall Study Reason not Specified	8	1

Baseline Characteristics

Baseline height data is available for n=36,10 participants, respectively.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) n=46 Participants Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) n=11 Participants Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).	Total n=57 Participants Total of all reporting groups
Age, Continuous	71.9 years STANDARD_DEVIATION 7.41 • n=46 Participants	69.5 years STANDARD_DEVIATION 12.50 • n=11 Participants	71.4 years STANDARD_DEVIATION 8.54 • n=57 Participants
Age, Customized <60 years	4 participants n=46 Participants	2 participants n=11 Participants	6 participants n=57 Participants
Age, Customized ≥60 years	42 participants n=46 Participants	9 participants n=11 Participants	51 participants n=57 Participants
Sex: Female, Male Female	22 Participants n=46 Participants	3 Participants n=11 Participants	25 Participants n=57 Participants
Sex: Female, Male Male	24 Participants n=46 Participants	8 Participants n=11 Participants	32 Participants n=57 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 participants n=46 Participants	0 participants n=11 Participants	2 participants n=57 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	34 participants n=46 Participants	9 participants n=11 Participants	43 participants n=57 Participants
Race/Ethnicity, Customized Not Reported	6 participants n=46 Participants	1 participants n=11 Participants	7 participants n=57 Participants
Race/Ethnicity, Customized White	36 participants n=46 Participants	10 participants n=11 Participants	46 participants n=57 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=46 Participants	0 participants n=11 Participants	3 participants n=57 Participants
Race/Ethnicity, Customized Asian	1 participants n=46 Participants	0 participants n=11 Participants	1 participants n=57 Participants
Region of Enrollment United States	33 participants n=46 Participants	9 participants n=11 Participants	42 participants n=57 Participants
Region of Enrollment France	11 participants n=46 Participants	2 participants n=11 Participants	13 participants n=57 Participants
Region of Enrollment Canada	2 participants n=46 Participants	0 participants n=11 Participants	2 participants n=57 Participants
Height	165.8 cm STANDARD_DEVIATION 8.35 • n=36 Participants • Baseline height data is available for n=36,10 participants, respectively.	171.4 cm STANDARD_DEVIATION 9.98 • n=10 Participants • Baseline height data is available for n=36,10 participants, respectively.	167.0 cm STANDARD_DEVIATION 8.93 • n=46 Participants • Baseline height data is available for n=36,10 participants, respectively.
Weight	73.7 kg STANDARD_DEVIATION 13.80 • n=45 Participants • Baseline weight data is available for n=45,11 participants, respectively.	80.4 kg STANDARD_DEVIATION 17.27 • n=11 Participants • Baseline weight data is available for n=45,11 participants, respectively.	75.0 kg STANDARD_DEVIATION 14.62 • n=56 Participants • Baseline weight data is available for n=45,11 participants, respectively.
Baseline Body Surface Area (BSA)	1.83 m^2 STANDARD_DEVIATION 0.203 • n=36 Participants • Baseline BSA data is available for n=36,10 participants, respectively.	1.94 m^2 STANDARD_DEVIATION 0.262 • n=10 Participants • Baseline BSA data is available for n=36,10 participants, respectively.	1.86 m^2 STANDARD_DEVIATION 0.219 • n=46 Participants • Baseline BSA data is available for n=36,10 participants, respectively.
Years Since Initial Diagnosis	0.65 years STANDARD_DEVIATION 0.793 • n=46 Participants	0.82 years STANDARD_DEVIATION 0.780 • n=11 Participants	0.68 years STANDARD_DEVIATION 0.787 • n=57 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0	9 participants n=46 Participants	3 participants n=11 Participants	12 participants n=57 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1	29 participants n=46 Participants	8 participants n=11 Participants	37 participants n=57 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2	8 participants n=46 Participants	0 participants n=11 Participants	8 participants n=57 Participants

PRIMARY outcome

Timeframe: Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)

Population: Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. In 2 participants disease transformed from MDS to AML. One participant is considered AML and one participant is considered MDS in the calculation, based on the timing of their transformation.

Outcome measures

Outcome measures
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) n=35 Participants Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) n=10 Participants Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
Best Overall Response Rate (ORR) Based on Investigator's Assessment CR + PR	6 participants	0 participants
Best Overall Response Rate (ORR) Based on Investigator's Assessment Complete Remission (CR + CRi + Marrow CRi)	1 participants	0 participants
Best Overall Response Rate (ORR) Based on Investigator's Assessment Partial Remission (PR + PRi)	5 participants	0 participants
Best Overall Response Rate (ORR) Based on Investigator's Assessment Stable Disease as Best Response	17 participants	2 participants

SECONDARY outcome

Population: Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better.

PFS is defined as the time from the date of first study drug administration to the date of first documented progressive disease (PD) or death.

Outcome measures

Outcome measures
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) n=35 Participants Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) n=10 Participants Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
Progression Free Survival (PFS)	55.0 days Interval 47.0 to 67.0	38.0 days Interval 35.0 to 113.0

SECONDARY outcome

Population: Response--Evaluable Population included all participants who had measurable disease, received at least 1 dose of alisertib, and had at least 1 post baseline response assessment. All responders were evaluated in this outcome measure. For a participant that has not progressed, DOR is censored at the last response assessment that is SD or better.

Duration of response is defined as the time from the date of first documentation of a response to the date of first documented PD.

Outcome measures

Outcome measures
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) n=6 Participants Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
Duration of Response (DOR)	409.0 days Interval 57.0 to 596.0	—

SECONDARY outcome

Population: Safety population was defined as all participants who received any amount of alisertib.

Best overall HI response is defined as percentage of participants with response as assessed by Investigator based on IWG criteria: 1)Erythroid response (pretreatment,\<11 g/dL): hemoglobin (Hgb) increase by ≥1.5 g/dL, relevant reduction of units of red blood cell (RBC) transfusions by absolute number of at least 4 RBC transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks. Only RBC transfusions given for Hgb of ≤9.0 g/dL pretreatment will count in RBC transfusion response evaluation. 2)Platelet response (pretreatment,\<100x10\^9/L):Absolute increase of ≥30x10\^9/L for participants starting-\>20x10\^9/L platelets, increase \<20x10\^9/L to \>20x10\^9/L by at least 100%. 3)Neutrophil response (pretreatment,\<1.0x10\^9/L):At least 100% increase and an absolute increase \>0.5x10\^9/L. 4)Progression or relapse after HI:At least 1 of following: 50% decrement from maximum response levels in granulocytes or platelets, or reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.

Outcome measures

Outcome measures
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) n=11 Participants Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment Erythroid Response	0 percentage of participants	—
Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment Platelet Response	0 percentage of participants	—
Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment Neutrophil Response	0 percentage of participants	—
Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment Progression or Relapse	0 percentage of participants	—
Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment Not Available	91 percentage of participants	—
Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment Unable to Assess	9 percentage of participants	—

SECONDARY outcome

Timeframe: First dose of study drug to 30 days after last dose (Up to 18.9 months)

Population: Safety population was defined as all participants who received any amount of alisertib.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator.

Outcome measures

Outcome measures
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) n=46 Participants Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) n=11 Participants Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths AE	46 participants	11 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths SAE	36 participants	8 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths Deaths	20 participants	2 participants

SECONDARY outcome

Timeframe: First dose of study drug to 30 days after last dose (Up to 18.9 months)

Population: Safety population was defined as all participants who received any amount of alisertib.

Vital signs measurements (blood pressure, heart rate, and oral temperature) were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Outcome measures
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) n=46 Participants Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) n=11 Participants Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Dyspnoea	12 participants	2 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Pyrexia	10 participants	2 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Hypotension	8 participants	0 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Atrial fibrillation	4 participants	1 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Tachycardia	3 participants	0 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Dyspnoea exertional	2 participants	1 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Hyperthermia	1 participants	0 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Hypothermia	1 participants	0 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Bradycardia	0 participants	1 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Ventricular tachycardia	1 participants	0 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Hypertension	1 participants	1 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Supraventricular tachycardia	2 participants	0 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Weight decreased	2 participants	0 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Tachypnoea	1 participants	0 participants

SECONDARY outcome

Timeframe: First dose of study drug to 30 days after last dose (Up to 18.9 months)

Population: Safety population was defined as all participants who received any amount of alisertib.

Abnormal Laboratory Values for Chemistry or Hematology tests that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. A treatment--emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Outcome measures
Measure	Alisertib 50 mg (Acute Myeloid Leukemia) n=46 Participants Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	Alisertib 50 mg (Myelodysplastic Syndrome) n=11 Participants Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Febrile neutropenia	17 participants	4 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Anaemia	14 participants	3 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Thrombocytopenia	9 participants	2 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Neutropenia	5 participants	3 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Leukopenia	3 participants	2 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hypoalbuminaemia	4 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Leukocytosis	3 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hypokalaemia	3 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hyponatraemia	3 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Neutrophil count decreased	3 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hypocalcaemia	2 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Clostridium difficile colitis	2 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Febrile bone marrow aplasia	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hypoxia	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hyperkalaemia	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hypernatraemia	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hyperglycaemia	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hypoglycaemia	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hypomagnesaemia	0 participants	1 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Hypophospataemia	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Alanine aminotransferase increased	0 participants	1 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Blood bilirubin increased	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Oxygen saturation decreased	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Lymphoedema	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Platelet count decreased	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Blood culture positive	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Blood magnesium decreased	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Blood creatinine increased	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events White blood cell count decreased	1 participants	0 participants
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Gilbert's syndrome	1 participants	0 participants

Adverse Events

Alisertib 50 mg (Acute Myeloid Leukemia)

Serious events: 36 serious events

Other events: 45 other events

Deaths: 0 deaths

Alisertib 50 mg (Myelodysplastic Syndrome)

Serious events: 8 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
Publication restrictions are in place

Restriction type: OTHER