NCT00807495 is a Phase 2 clinical trial of Alisertib in Diffuse Large B-cell Lymphoma, sponsored by Millennium Pharmaceuticals, Inc..

Who is sponsoring NCT00807495?

NCT00807495 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT00807495?

Interventions in NCT00807495: Alisertib.

What condition does NCT00807495 study?

NCT00807495 studies Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Burkitt's Lymphoma, T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma, Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component.

Is NCT00807495 still recruiting?

NCT00807495 is currently completed. Last updated 27 March 2018.

Are results published for NCT00807495?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-27 · How we verify

NCT00807495

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

Completed Phase 2 Results posted Last updated 27 March 2018

What this trial tests

Phase 2 trial testing Alisertib in Diffuse Large B-cell Lymphoma in 48 participants. Completed in 13 February 2013.

Timeline

10 February 2009

Primary endpoint
4 January 2011

13 February 2013

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	10 February 2009
Primary completion	4 January 2011
Estimated completion	13 February 2013
Sites	1 location across United States

Drugs / interventions tested

Alisertib — full drug profile →

Conditions studied

Diffuse Large B-cell Lymphoma — all drugs for Diffuse Large B-cell Lymphoma →
Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →
Burkitt's Lymphoma — all drugs for Burkitt's Lymphoma →
T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma — all drugs for T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Diffuse Large B-cell Lymphoma or Mantle Cell 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.

Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) Primary · Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years)

Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria).

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	25
Alisertib 50 mg BID Starting Dose (MCL)	23
Alisertib 50 mg BID Starting Dose (TFL)	40
Alisertib 50 mg BID Starting Dose (BL)	100
Alisertib 50 mg BID Starting Dose (ATL)	50

Time to Progression (TTP) Secondary · Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)

Time to progression (TTP) is defined as the time in days from the date of first study drug administration to the date of first documentation of Progressive Disease (PD) according to IWG criteria (Cheson 2007). PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	84.0	48.0 – 430.0
Alisertib 50 mg BID Starting Dose (MCL)	139.0	48.0 – 809.0
Alisertib 50 mg BID Starting Dose (TFL)	NA	NA – NA
Alisertib 50 mg BID Starting Dose (BL)	NA	NA – NA
Alisertib 50 mg BID Starting Dose (ATL)	237.0	46.0 – 631.0

Progression Free Survival (PFS) Secondary · Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)

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

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	84.0	48.0 – 364.0
Alisertib 50 mg BID Starting Dose (MCL)	139.0	48.0 – 809.0
Alisertib 50 mg BID Starting Dose (TFL)	NA	NA – NA
Alisertib 50 mg BID Starting Dose (BL)	NA	NA – NA
Alisertib 50 mg BID Starting Dose (ATL)	237.0	46.0 – 631.0

Duration of Response (DOR) Secondary · Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)

DOR is defined as the time from the date of first documentation of a CR, or partial response (PR) to the date of first documentation of PD according to IWG criteria. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir, as described in the IWG response criteria (Cheson 2007).

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	454.0	182.0 – 565.0
Alisertib 50 mg BID Starting Dose (MCL)	646.0	243.0 – 646.0
Alisertib 50 mg BID Starting Dose (TFL)	NA	NA – NA
Alisertib 50 mg BID Starting Dose (BL)	NA	NA – NA
Alisertib 50 mg BID Starting Dose (ATL)	596.0	202.0 – 596.0

Number of Participants With Treatment-Emergent Adverse Events Secondary · First dose of study drug to 30 days after last dose (Up to 25 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and includes all-causality (ie, treatment-related and not treatment-related as assessed by the investigator).

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	22
Alisertib 50 mg BID Starting Dose (MCL)	13
Alisertib 50 mg BID Starting Dose (TFL)	5
Alisertib 50 mg BID Starting Dose (BL)	1
Alisertib 50 mg BID Starting Dose (ATL)	7

Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events Secondary · First dose of study drug to 30 days after last dose (Up to 25 months)

Vital signs (blood pressure, heart rate, and oral temperature) measurements 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.

Pyrexia

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	7
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	2

Hypotension

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	6
Alisertib 50 mg BID Starting Dose (MCL)	1
Alisertib 50 mg BID Starting Dose (TFL)	1
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	1

Weight decreased

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	2
Alisertib 50 mg BID Starting Dose (MCL)	1
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	1

Tachycardia

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	1
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	2

Hypertension

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	1
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	0

Bradycardia

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	1
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	0

Cardiac flutter

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	1
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	0

Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events Secondary · First dose of study drug to 30 days after last dose (Up to 25 months)

Abnormal laboratory values for chemistry or hematology tests that were assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4). A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Thrombocytopenia

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	11
Alisertib 50 mg BID Starting Dose (MCL)	5
Alisertib 50 mg BID Starting Dose (TFL)	3
Alisertib 50 mg BID Starting Dose (BL)	1
Alisertib 50 mg BID Starting Dose (ATL)	5

Alanine aminotransferase increased

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	6
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	1

Aspartate aminotransferase increased

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	6
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	1

Blood alkaline phosphatase increased

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	6
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	1

Hypokalaemia

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	3
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	1
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	1

Blood lactate dehydrogenase increased

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	3
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	1

Blood creatinine increased

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	0
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	2

Blood potassium decreased

Group	Value	95% CI
Alisertib 50 mg BID Starting Dose (DLBL)	1
Alisertib 50 mg BID Starting Dose (MCL)	0
Alisertib 50 mg BID Starting Dose (TFL)	0
Alisertib 50 mg BID Starting Dose (BL)	0
Alisertib 50 mg BID Starting Dose (ATL)	1

Adverse events — posted to ClinicalTrials.gov

Time frame: First dose of study drug to 30 days after last dose (Up to 25 Months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Alisertib 50 mg BID Starting Dose (DLBL)

Serious: 16/22 (73%)

Deaths: —

Alisertib 50 mg BID Starting Dose (MCL)

Serious: 4/13 (31%)

Deaths: —

Alisertib 50 mg BID Starting Dose (TFL)

Serious: 5/5 (100%)

Deaths: —

Alisertib 50 mg BID Starting Dose (BL)

Serious: 0/1 (0%)

Deaths: —

Alisertib 50 mg BID Starting Dose (ATL)

Serious: 4/7 (57%)

Deaths: —

Serious adverse events (45 terms)

Reaction	System	Alisertib 50 mg BID Starti…	Alisertib 50 mg BID Starti…	Alisertib 50 mg BID Starti…	Alisertib 50 mg BID Starti…	Alisertib 50 mg BID Starti…
Febrile Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Haemolytic anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—
Osteomyelitis	Infections and infestations	—	—	—	—	—
Oropharyngeal candidiasis	Infections and infestations	—	—	—	—	—
Escherichia bacteraemia	Infections and infestations	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Colitis ischaemic	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Multi-organ failure	General disorders	—	—	—	—	—

Other adverse events (160 terms — click to expand)

Reaction	System	Alisertib 50 mg BID Starti…	Alisertib 50 mg BID Starti…	Alisertib 50 mg BID Starti…	Alisertib 50 mg BID Starti…	Alisertib 50 mg BID Starti…
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Haemoglobin decreased	Investigations	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—
Catheter site erythema	General disorders	—	—	—	—	—
Rash pruritic	Skin and subcutaneous tissue disorders	—	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—	—

Most-reported serious reactions: Febrile Neutropenia, Stomatitis, Neutropenia, Pneumonia, Dehydration, Pancytopenia, Urinary tract infection, Lymphoma.

Data from ClinicalTrials.gov NCT00807495 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in participants with relapsed or refractory non-hodgkin's lymphoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cell cycle proteins as promising targets in cancer therapy.
Otto T, Sicinski P. · · 2017 · cited 1412× · PMID 28127048 · DOI 10.1038/nrc.2016.138
Therapeutic targeting of "undruggable" MYC.
Llombart V, Mansour MR. · · 2022 · cited 349× · PMID 34942444 · DOI 10.1016/j.ebiom.2021.103756
Mitotic chromosomal instability and cancer: mouse modelling of the human disease.
Schvartzman JM, Sotillo R, Benezra R. · · 2010 · cited 349× · PMID 20094045 · DOI 10.1038/nrc2781
Phase II study of alisertib, a selective Aurora A kinase inhibitor, in relapsed and refractory aggressive B- and T-cell non-Hodgkin lymphomas.
Friedberg JW, Mahadevan D, Cebula E, Persky D, et al · · 2014 · cited 166× · PMID 24043741 · DOI 10.1200/jco.2012.46.8793
The two sides of chromosomal instability: drivers and brakes in cancer.
Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
Aurora kinase A in gastrointestinal cancers: time to target.
Katsha A, Belkhiri A, Goff L, El-Rifai W. · · 2015 · cited 74× · PMID 25987188 · DOI 10.1186/s12943-015-0375-4
Emerging roles of Aurora-A kinase in cancer therapy resistance.
Zheng D, Li J, Yan H, Zhang G, et al · · 2023 · cited 71× · PMID 37521867 · DOI 10.1016/j.apsb.2023.03.013
The potential role of Aurora kinase inhibitors in haematological malignancies.
Farag SS. · · 2011 · cited 51× · PMID 21980926 · DOI 10.1111/j.1365-2141.2011.08898.x

Verify or expand the search:

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Other Millennium Pharmaceuticals, Inc. trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00807495 (US National Library of Medicine, public domain)
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: 27 March 2018

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/NCT00807495.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00807495

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (45 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Alisertib

Other recruiting trials for Diffuse Large B-cell Lymphoma

Other Millennium Pharmaceuticals, Inc. trials

Verify against primary sources