18 and older, any sex, with Advanced Solid Tumors or Lymphomas. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)Primary· Treatment Cycle 1
MTD was defined as highest dose at which \<2 participants experienced a dose-limiting toxicity (DLT). DLT was defined as any of the following events considered possibly related to therapy with alisertib by the investigator: 1. Grade 4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>7 days; 2. Grade 4 neutropenia with fever (oral or ear temperature ≥38.5°C); 3. Grade 4 thrombocytopenia (platelets \<25,000/mm\^3) for \>7 days; 4. Platelet count \<10,000 cells/mm\^3; 5. ≥Grade 3 thrombocytopenia with clinically significant bleeding; 6. Delay in initiation of subsequent cycle by \>
Group
Value
95% CI
Alisertib 30 mg or 40 mg
30
Number of Participants With Adverse Events and Serious Adverse EventsPrimary· First dose to 30 days past last dose (Up to 12.1 Months)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
AE
Group
Value
95% CI
Alisertib 30 mg
30
Alisertib 40 mg
6
SAE
Group
Value
95% CI
Alisertib 30 mg
15
Alisertib 40 mg
4
Number of Participants With Abnormal Clinical Laboratory Values Reported as Adverse EventsPrimary· First dose to 30 days past last dose (Up to 12.1 Months)
Laboratory AEs in the following system organ classes (SOCs) are reported: blood and lymphatic system disorders, investigations, and metabolism and nutrition disorders. An abnormal laboratory value was assessed as an AE if that value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A treatment¬-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Neutropenia
Group
Value
95% CI
Alisertib 30 mg
19
Alisertib 40 mg
5
Anaemia
Group
Value
95% CI
Alisertib 30 mg
9
Alisertib 40 mg
4
Thrombocytopenia
Group
Value
95% CI
Alisertib 30 mg
6
Alisertib 40 mg
1
Febrile neutropenia
Group
Value
95% CI
Alisertib 30 mg
4
Alisertib 40 mg
1
Leukopenia
Group
Value
95% CI
Alisertib 30 mg
2
Alisertib 40 mg
2
White blood cell count decreased
Group
Value
95% CI
Alisertib 30 mg
7
Alisertib 40 mg
0
Aspartate aminotransferase increased
Group
Value
95% CI
Alisertib 30 mg
6
Alisertib 40 mg
0
Neutrophil count decreased
Group
Value
95% CI
Alisertib 30 mg
4
Alisertib 40 mg
0
Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse EventsPrimary· First dose to 30 days past last dose (Up to 12.1 Months)
Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study.
Hypertension
Group
Value
95% CI
Alisertib 30 mg
1
Alisertib 40 mg
0
Hypotension
Group
Value
95% CI
Alisertib 30 mg
1
Alisertib 40 mg
0
Bradycardia
Group
Value
95% CI
Alisertib 30 mg
1
Alisertib 40 mg
0
Pyrexia
Group
Value
95% CI
Alisertib 30 mg
8
Alisertib 40 mg
1
Cmax: Maximum Observed Concentration for AlisertibPrimary· Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose
Day 1
Group
Value
95% CI
Alisertib 30 mg
1442.5
± 534.80
Alisertib 40 mg
1871.7
± 429.62
Day 7
Group
Value
95% CI
Alisertib 30 mg
3000.0
± 1329.38
Alisertib 40 mg
3686.7
± 885.45
Tmax: Time to First Occurrence of Cmax for AlisertibPrimary· Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose
Day 1
Group
Value
95% CI
Alisertib 30 mg
3.0
2 – 8
Alisertib 40 mg
2.0
2 – 3
Day 7
Group
Value
95% CI
Alisertib 30 mg
2.9
1 – 6
Alisertib 40 mg
2.0
1 – 3
AUCτ: Area Under the Concentration-Time Curve From Time 0 to End of Dosing Interval (τ) for AlisertibPrimary· Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose
Day 1
Group
Value
95% CI
Alisertib 30 mg
9549.0
± 4119.30
Alisertib 40 mg
11811.7
± 2845.76
Day 7
Group
Value
95% CI
Alisertib 30 mg
24377.9
± 13261.61
Alisertib 40 mg
30683.3
± 9575.68
Dose Normalized AUCτ: Area Under the Concentration-Time Curve From Time 0 to Time t for AlisertibPrimary· Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose
Dose normalized AUCτ was obtained using AUCτ divided by alisertib dose in milligrams.
Group
Value
95% CI
Alisertib 30 mg
812.9
± 441.90
Alisertib 40 mg
766.8
± 238.88
T1/2: Terminal Half-Life for AlisertibPrimary· Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose
Group
Value
95% CI
Alisertib 30 mg
16.750
± 8.1710
Alisertib 40 mg
14.795
± 4.5715
Rac: Accumulation Ratio for AlisertibPrimary· Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose
Group
Value
95% CI
Alisertib 30 mg
2.830
± 1.2955
Alisertib 40 mg
2.690
± 1.0638
PTR: Peak Trough Ratio During a Dosing Interval, at Steady State for AlisertibPrimary· Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose
Group
Value
95% CI
Alisertib 30 mg
2.254
± 0.6458
Alisertib 40 mg
2.207
± 0.3946
CLss/F: Apparent Clearance After Extravascular Administration, at Steady State, Calculated Using AUCτ for AlisertibPrimary· Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose
Group
Value
95% CI
Alisertib 30 mg
2.9357
± 1.37091
Alisertib 40 mg
2.8083
± 1.20259
Adverse events — posted to ClinicalTrials.gov
Time frame: First dose to 30 days past last dose (Up to 12.1 Months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Alisertib 30 mg
Serious: 15/30 (50%)
Deaths: —
Alisertib 40 mg
Serious: 4/6 (67%)
Deaths: —
Serious adverse events (25 terms)
Reaction
System
Alisertib 30 mg
Alisertib 40 mg
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Stomatitis
Gastrointestinal disorders
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Leukopenia
Blood and lymphatic system disorders
—
—
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Ascites
Gastrointestinal disorders
—
—
Bacteraemia
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Subcutaneous abscess
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Platelet count decreased
Investigations
—
—
Neutrophil count decreased
Investigations
—
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
—
Lower extremity mass
Musculoskeletal and connective tissue disorders
—
—
Axillary mass
Musculoskeletal and connective tissue disorders
—
—
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study was to determine the safety profile, maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to characterize the pharmacokinetic (PK) profile of alisertib twice daily (BID) dosing for 7 days in East Asian participants with advanced solid tumors or lymphomas. The secondary objective was to describe any antitumor activity that may have been observed with alisertib treatment.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07465757 — A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
· Phase 2
· not yet recruiting
NCT06369285 — A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Meta
· Phase 2
· recruiting
NCT06095505 — A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
· Phase 2
· recruiting
NCT04555837 — Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer
· Phase 1, PHASE2
· completed
NCT04479306 — Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage I
· Phase 1
· completed
Other recruiting trials for Advanced Solid Tumors
Currently open trials in the same condition.
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· EARLY_PHASE1
· recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors
· Phase 1, PHASE2
· recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.
· EARLY_PHASE1
· recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
Other Millennium Pharmaceuticals, Inc. trials
Trials by the same sponsor.
NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob
· Phase 1
· withdrawn
NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati
· Phase 1
· completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab
· Phase 1
· completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
· Phase 1
· completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
Last refreshed: 15 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01512758.