18 and older, any sex, with B-cell Follicular Lymphoma or B-cell Marginal Zone Lymphoma. 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.
Number of Participants With Dose-Limiting Toxicity (DLT)Primary· From first dose of study drug to 30 days after the last dose (up to 422 days)
DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib:1. Grade 4 neutropenia lasting ≥7 consecutive days, 2. Grade 4 neutropenia with fever and/or infection 3. Platelet count \<25,000/mm\^3 4. Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis 5. Grade 3 or greater diarrhea despite maximal supportive therapy with loperamide 6. Any other Grade 3 or greater nonhematologic toxicity, with the following ex
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
1
Alisertib 35 mg PIC QD 21D
2
Alisertib 35 mg PIC QD 14D
0
Alisertib 45 mg PIC QD 14D
1
Alisertib 65 mg PIC QD 14D
2
Alisertib 90 mg PIC QD 14D
2
Alisertib 40 mg ECT QD 14D
2
Alisertib 30 mg ECT BID 7D
0
Alisertib 40 mg ECT BID 7D
0
Alisertib 50 mg ECT BID 7D
1
Maximum Tolerated Dose (MTD) of AlisertibPrimary· From first dose of study drug to 30 days after the last dose (up to 422 days)
MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants.
Group
Value
95% CI
Alisertib
50
Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1Primary· Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
833.2
± 49.5
Alisertib 35 mg PIC QD 21D
1078.3
± 26.4
Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21Primary· Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
1337.6
± 57.8
Alisertib 35 mg PIC QD 21D
1451.9
± 26.2
Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1Primary· Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
2.0
2.0 – 3.3
Alisertib 35 mg PIC QD 21D
2.0
1.1 – 5.2
Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21Primary· Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
2.0
1.0 – 5.0
Alisertib 35 mg PIC QD 21D
2.0
2.0 – 2.0
AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21Primary· Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
14846
± 69.7
Alisertib 35 mg PIC QD 21D
16528
± 35.6
Terminal Half-Life (t1/2) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21Primary· Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
20.5
± 7.3
Alisertib 35 mg PIC QD 21D
19.5
± 6.0
Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21Primary· Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
1.9
± 1.1
Alisertib 35 mg PIC QD 21D
1.5
± 0.5
Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21Primary· Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
6.0
± 4.4
Alisertib 35 mg PIC QD 21D
4.3
± 1.5
CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21Primary· Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose
Group
Value
95% CI
Alisertib 25mg PIC QD 21D
3.2
± 113
Alisertib 35 mg PIC QD 21D
4.1
± 45
Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1Primary· Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Group
Value
95% CI
Alisertib 35 mg PIC QD 14D
726.5
± 34.8
Alisertib 45 mg PIC QD 14D
1637.0
± 58.0
Alisertib 65 mg PIC QD 14D
1773.4
± 44.3
Alisertib 90 mg PIC QD 14D
2497.4
± 24.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug to 30 days after the last dose (up to 422 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1 PIC Dose Escalation
Serious: 12/28 (43%)
Deaths: —
Part 1 ECT Dose Escalation
Serious: 15/28 (54%)
Deaths: —
Part 2 PTCL
Serious: 2/2 (100%)
Deaths: —
Serious adverse events (43 terms)
Reaction
System
Part 1 PIC Dose Escalation
Part 1 ECT Dose Escalation
Part 2 PTCL
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
—
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Hypercalcaemia
Metabolism and nutrition disorders
—
—
—
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
Flank pain
Musculoskeletal and connective tissue disorders
—
—
—
Pathological fracture
Musculoskeletal and connective tissue disorders
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
Septic shock
Infections and infestations
—
—
—
Staphylococcal infection
Infections and infestations
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
Systemic inflammatory response syndrome
General disorders
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is an open-label, multicenter, phase 1 study of MLN8237 in participants with advanced hematological malignancies for whom there are limited standard treatment options.
Publications & conference data
8 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
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· completed
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· 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: 31 May 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/NCT00697346.