A Study Of MLN8054 In Patients With Advanced Solid Tumors

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-11-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2008-03-28
First Submitted that Met QC Criteria 2005-11-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2008-04-01
First Posted (ESTIMATED) 2005-11-07	Results First Posted N/A	Last Verified 2008-03

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1 MLN8054	DRUG: MLN8054 MLN8054 will be administered orally in multiple divided daily doses for 7 days to 21 consecutive days. A 14-day recovery period will follow each dosing period, regardless of its duration. MLN8054 will be supplied in capsules of 5 mg or 25 mg with dose str

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

MLN8054

DRUG: MLN8054

MLN8054 will be administered orally in multiple divided daily doses for 7 days to 21 consecutive days. A 14-day recovery period will follow each dosing period, regardless of its duration. MLN8054 will be supplied in capsules of 5 mg or 25 mg with dose str

Primary Outcome Measures	Measure Description	Time Frame
The safety of MLN8054 will be based on the continuous monitoring and observation of patients and the collection and evaluation of adverse events and serious adverse events and the assessment of their potential relationship to the study medication.		7 consecutive days of therapy with the option to increase to 14 or 21 days of therapy

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed metastatic and/or advanced solid tumors(including lymphomas) for which standard treatment does not offer or no longer offers curative or life-prolonging potential
Aged 18 years or more
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Expected survival longer than 3 months from enrollment in the study
Radiographically or clinically evaluable tumor; however, measurable disease is not required for participation in this study
Suitable venous access for the conduct of blood sampling for MLN8054 PK
Recovered from the reversible effects of prior antineoplastic therapy with at least 4 weeks elapsed since the last exposure to cytotoxic chemotherapy or to radiotherapy and at least 6 weeks elapsed since exposure to nitrosoureas or mitomycin C. Patients treated with fully human monoclonal antibodies must not have received treatment with such antibodies for at least 6 weeks, and those treated with chimeric monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks. Patients treated with noncytotoxic small molecule drugs (eg, tyrosine kinase inhibitors, such as Tarceva, and hormonal agents, such as Femara) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8054 is given.
Male patients must use an appropriate method of barrier contraception (eg, condoms)and inform any sexual partners that they must also use a reliable method of contraception (eg, birth control pills) during the study and for 21 days after the last dose of study treatment.
Female patients must be postmenopausal, surgically sterilized, or willing to use reliable methods of birth control (eg, a hormonal contraceptive, an intrauterine device, diaphragm with spermicide, or abstinence) during the study and for 21 days after the last dose of study treatment.
Able to give informed consent before the conduct of any study-related procedure not part of normal medical care and to comply with the protocol

Pregnant or lactating
Major surgery within the 28 days preceding the first dose of study treatment
Serious infection within the 28 days before the first dose of study treatment
Life-threatening illness unrelated to cancer
Ongoing nausea or vomiting of any severity
> Grade 1 diarrhea
Known GI disease that could interfere with the oral absorption or tolerance of MLN8054
Difficulty swallowing capsules
Inability to fast overnight before the morning dose of MLN8054 and to remain nothing by mouth ([NPO] except for water and prescribed medications) for 2 hours after each dose of MLN8054
Received more than 4 previous cytotoxic chemotherapeutic regimens, including regimens used as adjuvant or neo-adjuvant therapies. There is no limit on the number of noncytotoxic therapies (eg, hormonal and immunologic) that patients may have received. Tyrosine kinase inhibitors (eg, Tarceva and Iressa) are considered noncytotoxic compounds.
Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution
Prior treatment with radiation therapy involving > 25% of the hematopoietically active bone marrow (see Table 15-1 for the distribution of active bone marrow in adults)
Clinical and/or radiographic evidence of cerebral metastases. However, patients who have a history of central nervous system (CNS) metastasis but who have no radiographic or clinical evidence of residual tumor (eg, following complete surgical resection) are not excluded from participation in this study.
Clinically significant abnormalities or arrhythmias on 12-lead electrocardiogram (ECG) in the opinion of the investigator
Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
Known or suspected disorder of bilirubin metabolism or excretion, including, but not limited to, Gilbert's syndrome, Crigler-Najjar syndrome, Dubin-Johnson syndrome, and Rotor syndrome
Inclusion in a trial of an investigational drug in the previous 4 weeks
Admission of alcohol abuse or an inability to restrict consumption of alcohol to no more than 1 standard unit of alcohol per day during the study and for 21 days from the last dose of study treatment.

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record

Study Overview

Study Record Dates

Study Plan

Design Details

Contacts and Locations

Participation Criteria

Collaborators and Investigators

Publications

Treat yourself

Let Us Take Care Of You

About

Events

Fundraising

Contact Us

Learn

Resources

Patients

Caregivers

Learn

Resources

PatientS

Caregivers

Clinical Trial Record