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 range18 Years

SexALL

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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…

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

View on ClinicalTrials.gov More B-cell Follicular Lymphoma trials