CompletedPhase 1

Study of MLN8237 in Participants With Advanced Hematological Malignancies

United States58 participantsStarted 2008-07-11

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Relapsed or refractory disease and a histologically or cytologically confirmed hematological malignancy of the following type for which standard curative treatment does not exist or is no longer effective: * B-cell Follicular lymphoma * B-cell Marginal zone lymphoma * Diffuse large B-cell lymphoma * B-cell Mantle cell lymphoma * B-cell Small lymphocytic lymphoma (SLL) * B-Cell Chronic lymphocytic leukemia (B-CLL) * Multiple myeloma * Waldenstrom's macroglobulinemia * Noncutaneous peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) * Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma, enteropathy associated T-cell lymphoma (EATCL), NK lymphoma (NKL) * Participants with diffuse large B-cell lymphoma must have failed, be ineligible for, or have refused an autologous stem cell transplant. There is no restriction regarding the maximum number of prior regimens. * Aged 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Radiographically or clinically evaluable disease for Part 1 of this study and measurable disease for Part 2 of this study * Suitable venous access for the conduct of blood sampling for MLN8237 pharmacokinetics (PK) * Recovered from the reversible effects of prior antineoplastic treatment (with the exception of alopecia and Grade 1 neuropathy) Exclusion Criteria: * Pregnant or lactating * Treatment with clinically significant enzyme inducers within 14 d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Dose-Limiting Toxicity (DLT)

Timeframe: From first dose of study drug to 30 days after the last dose (up to 422 days)

Maximum Tolerated Dose (MTD) of Alisertib

Timeframe: From first dose of study drug to 30 days after the last dose (up to 422 days)

Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1

Timeframe: Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose

Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21

Timeframe: Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose

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

Timeframe: Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose

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

Timeframe: Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose

Trial details

NCT IDNCT00697346

SponsorMillennium Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-10-01

Results submitted2018-01-04

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