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Breast NeoplasmPhase 1NCT00249301

A Study of MLN8054 in Patients With Advanced Solid Tumors

A Phase 1 study testing MLN8054 in people with Breast Neoplasm and Colon Neoplasm, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine (1) The side effects or toxicities of MLN8054;(2) The highest dose where side effects or toxicities are not too severe; (3) How MLN8054 is absorbed into the general blood circulation and eliminated from the body; and (4) The levels of MLN8054 in the blood that are needed to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MLN8054
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteUnited States
Study dates
Oct 2005to Jan 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: An Open-Label, Dose Escalation Phase 1 Study of MLN8054, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Solid Tumors

The purpose of this study is to determine (1) The side effects or toxicities of MLN8054;(2) The highest dose where side effects or toxicities are not too severe; (3) How MLN8054 is absorbed into the general blood circulation and eliminated from the body; and (4) The levels of MLN8054 in the blood that are needed to inhibit Aurora A kinase.

Being tested
MLN8054
Keywords
Breast Cancer, Colon Cancer, Pancreatic Cancer, Bladder Cancer
Medical subject headings
Breast Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MLN8054Drug

    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 strength expressed as the milligrams of active drug (free acid). MLN8054 will be given on an empty stomach. Patients will be instructed to take nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose.

Study groups in NCT00249301
Study groupRoleWhat they receive
1ExperimentalMLN8054
Receives: Drug: MLN8054

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 consecutive days of therapy with the option to increase to 14 or 21 days of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00249301
Sponsor's protocol ID
C10001
Status last verified
Mar 2008
First submitted
4 Nov 2005
Last updated
1 Apr 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MLN8054 in people with Breast Neoplasm and Colon Neoplasm, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 7 consecutive days of therapy with the option to increase to 14 or 21 days of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00249301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2008.

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