Trial · NCT00697346
Study of MLN8237 in Participants With Advanced Hematological Malignancies
NCT00697346, Phase 1, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2019-05-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of MLN8237 in Participants With Advanced Hematological Malignancies. Trials, record NCT00697346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00697346
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of MLN8237 in Participants With Advanced Hematological Malignancies
- NCT number
- NCT00697346
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 58 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
B-cell Follicular Lymphoma, B-cell Marginal Zone Lymphoma, Diffuse Large B-cell Lymphoma, B-cell Mantle Cell Lymphoma, B-cell Small Lymphocytic Lymphoma, B-Cell Chronic Lymphocytic Leukemia, Multiple Myeloma, Waldenstrom's Macroglobulinemia, Noncutaneous Peripheral T-cell Lymphoma Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Enteropathy Associated T-cell Lymphoma, NK Lymphoma
- Interventions
- Alisertib
- First posted
- 2008-06-13
- Last updated
- 2019-05-31
- Results first posted
- 2019-05-31
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicity (DLT) | 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 exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (\<1 week) Grade 3 fatigue 7. Treatment delay of \>21 days due to failure of adequate hematologic or non-hematologic recovery from previous cycle of treatment 8. Other alisertib related non-hematologic toxicities ≥Grade 2 that, in the opinion of the investigator required a dose reduction or discontinuation of therapy with alisertib. |
| Primary | Maximum Tolerated Dose (MTD) of Alisertib | 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. |
| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1 | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | |
| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | |
| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1 | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | |
| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | |
| Primary | 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 21 | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | |
| Primary | Terminal Half-Life (t1/2) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | |
| Primary | Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | |
| Primary | Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-Limiting Toxicity (DLT) | From first dose of study drug to 30 days after the last dose (up to 422 days) | DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred. | participants | NUMBER |
| PRIMARY | Maximum Tolerated Dose (MTD) of Alisertib | From first dose of study drug to 30 days after the last dose (up to 422 days) | DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred. | mg BID for 7 days | NUMBER |
| PRIMARY | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1 | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | Pharmacokinetic (PK) evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. | nM | GEOMETRIC_MEAN |
| PRIMARY | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | nM | GEOMETRIC_MEAN |
| PRIMARY | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1 | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | hours (h) | MEDIAN |
| PRIMARY | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | h | MEDIAN |
| PRIMARY | 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 21 | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | nM*h | GEOMETRIC_MEAN |
| PRIMARY | Terminal Half-Life (t1/2) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | h | MEAN |
| PRIMARY | Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | ratio | MEAN |
| PRIMARY | Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis, with data available at the given time point. Here number of participants analyzed were participants evaluable for this outcome measure. | ratio | MEAN |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group105
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 25mg PIC QD 21D | 1 | participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 35 mg PIC QD 21D | 2 | participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 35 mg PIC QD 14D | 0 | participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 45 mg PIC QD 14D | 1 | participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 65 mg PIC QD 14D | 2 | participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 90 mg PIC QD 14D | 2 | participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 40 mg ECT QD 14D | 2 | participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 30 mg ECT BID 7D | 0 | participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 40 mg ECT BID 7D | 0 | participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Alisertib 50 mg ECT BID 7D | 1 | participants |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: PIC Dose Escalation | 28 | |
| Overall Study | STARTED | Part 1: ECT Dose Escalation | 28 | |
| Overall Study | STARTED | Part 2: PTCL | 2 | |
| Overall Study | COMPLETED | Part 1: PIC Dose Escalation | 0 | |
| Overall Study | COMPLETED | Part 1: ECT Dose Escalation | 2 | |
| Overall Study | COMPLETED | Part 2: PTCL | 1 | |
| Overall Study | NOT COMPLETED | Part 1: PIC Dose Escalation | 28 | |
| Overall Study | NOT COMPLETED | Part 1: ECT Dose Escalation | 26 | |
| Overall Study | NOT COMPLETED | Part 2: PTCL | 1 |
Source ClinicalTrials.gov
Adverse events363
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Part 1 PIC Dose Escalation | 13 | 28 | 21 |
| other | Neutropenia | Blood and lymphatic system disorders | Part 1 ECT Dose Escalation | 18 | 28 | 35 |
| other | Neutropenia | Blood and lymphatic system disorders | Part 2 PTCL | 2 | 2 | 4 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 1 PIC Dose Escalation | 11 | 28 | 14 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 1 ECT Dose Escalation | 13 | 28 | 16 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 2 PTCL | 2 | 2 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 PIC Dose Escalation | 11 | 28 | 15 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 ECT Dose Escalation | 12 | 28 | 18 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 PTCL | 2 | 2 | 5 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 1 PIC Dose Escalation | 4 | 28 | 7 |
1 to 10 of 363Source ClinicalTrials.gov
See all 363 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 PIC Dose Escalation | ||
| Total, all-cause mortality | Part 1 ECT Dose Escalation | ||
| Total, all-cause mortality | Part 2 PTCL | ||
| Total, other adverse events | Part 1 PIC Dose Escalation | 28 | 28 |
| Total, other adverse events | Part 1 ECT Dose Escalation | 28 | 28 |
| Total, other adverse events | Part 2 PTCL | 2 | 2 |
| Total, serious adverse events | Part 1 PIC Dose Escalation | 12 | 28 |
| Total, serious adverse events | Part 1 ECT Dose Escalation | 15 | 28 |
| Total, serious adverse events | Part 2 PTCL | 2 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24352795 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00697346
GET https://conductscience.org/api/trials/v1/NCT00697346/registered?page=2