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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Neoplasm, Colon Neoplasm, Pancreatic Neoplasm, Bladder Neoplasm

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Trial Information

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

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

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

C10001

NCT ID:

NCT00249301

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Breast Neoplasm
  • Colon Neoplasm
  • Pancreatic Neoplasm
  • Bladder Neoplasm
  • Breast Cancer
  • Colon Cancer
  • Pancreatic Cancer
  • Bladder Cancer
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Colonic Neoplasms
  • Pancreatic Neoplasms

Name

Location

The Sarah Cannon Research InstituteNashville, Tennessee  37203