Study of MLN8237 in Patients With Advanced Hematological Malignancies

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Millennium Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00697346

First received: June 11, 2008

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 11, 2008

Last Updated Date

January 23, 2013

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of orally administered MLN8237; and to evaluate the pharmacokinetics of MLN8237. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Determine dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of orally administered MLN8237, evaluate pharmacokinetics and potential effect of MLN8237 exposure on Aurora A kinase inhibition in blood leukocytes. [ Time Frame: Duration of therapy ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00697346 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine if MLN8237 has antitumor activity as measured by tumor response. [ Time Frame: Evaluations will be repeated after every 2 cycles of MLN8237 have been completed for up to 12 months ] [ Designated as safety issue: No ]
To evaluate the potential effect of MLN8237 exposure on Aurora A kinase inhibition in blood leukocytes [ Time Frame: Before and during the first cycle of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To determine if MLN8237 has antitumor activity as measured by tumor response. [ Time Frame: Evaluations will be repeated after every 2 cycles of MLN8237 have been completed for up to 12 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of MLN8237 in Patients With Advanced Hematological Malignancies

Official Title ^ICMJE

An Open-label, Phase 1 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Hematological Malignancies

Brief Summary

This is an open-label, multicenter, phase 1 study of MLN8237 in subjects with advanced hematological malignancies for whom there are limited standard treatment options.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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)

Intervention ^ICMJE

Drug: MLN8237

MLN8237 administered twice daily (BID) on Days 1-7 of each cycle. The planned rest period is 14 days in length.

Number of Cycles: until progression or unacceptable toxicity, up to 12 months unless clinical benefit supports continued therapy.

Study Arm (s)

Experimental: 1

MLN8237

Intervention: Drug: MLN8237

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)
Subjects 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 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 days prior to the first dose of MLN8237 as specified in the protocol
Prior allogeneic bone marrow (or other organ) transplantation
Newly diagnosed or uncontrolled cancer-related CNS disease
Systemic antineoplastic treatment within 21 days preceding the first dose of study treatment. Exceptions requiring a 42-day recovery period from last treatment include: Nitrosoureas, mitomycin C or Rituximab, alemtuzumab (Campath®), or other unconjugated therapeutic antibody (21 days if clear evidence of progressive disease)
Treatment with radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan (Zevalin™), or tositumomab (Bexxar®) within 56 days preceding the first dose of study treatment
Antineoplastic treatment with glucocorticoids within 21 days preceding the first dose of study treatment
Radiotherapy involving <25% of the hematopoietically active bone marrow within 21 days preceding first dose of study treatment
Radiotherapy involving ≥25% of the hematopoietically active bone marrow within 42 days preceding first dose of study treatment
Inability to swallow capsules or known GI disease or GI procedures that could interfere with the oral absorption or tolerance of MLN8237. Examples include, but are not limited to, partial gastrectomy, history of small intestine surgery, and celiac disease.
History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease
Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection. Testing is not required in the absence of clinical findings or suspicion.
Patients who fail to meet laboratory values as specified in the protocol during the screening period

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00697346

Other Study ID Numbers ^ICMJE

C14003

Has Data Monitoring Committee

Responsible Party

Millennium Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Millennium Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Millennium Pharmaceuticals, Inc.

Information Provided By

Millennium Pharmaceuticals, Inc.

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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