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An Open-label, Phase 1 Study of the Relative Bioavailability, Food Effect, Safety and Tolerability of MLN8237 in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

Thank you

Trial Information

An Open-label, Phase 1 Study of the Relative Bioavailability, Food Effect, Safety and Tolerability of MLN8237 in Patients With Advanced Solid Tumors

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the

- 18 years or older

- Histologically or cytologically confirmed metastatic and/or advanced solid tumor

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception or abstain from heterosexual

- Male patients who agree to practice effective barrier contraception or agree to
abstain from heterosexual intercourse

- Voluntary written consent

- Suitable venous access for study-required blood sampling

- Measurable disease

- Recovered from effects of prior antineoplastic therapy

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the

- Female patients who are pregnant or lactating

- Serious medical or psychiatric illness that could interfere with protocol completion

- Major surgery within 14 days of first dose of MLN8237

- Antineoplastic therapy, radiation therapy or any experimental therapy 21 days prior
to first dose of MLN8237

- Nitrosoureas or mitomycin-C within 6 weeks before the first dose of MLN8237.

- Autologous stem cell transplant within 3 months before the first dose of MLN8237, or
prior allogeneic stem cell transplant at any time.

- Active infection requiring systemic therapy, or other serious infection

- Inability to swallow oral medication

- Gastrointestinal (GI) disease or GI procedure that could interfere with oral
absorption or tolerance of MLN8237

- Symptomatic brain metastasis

- Uncontrolled cardiovascular condition

- Diagnosis or treatment of another malignancy within 2 years preceding first dose of
study drug except nonmelanoma skin cancer or in situ malignancy completely resected

- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
hepatitis C

- Lactose-intolerant (Parts A and B only)

- Prior history of metabolic acidosis (Parts A and B only)

- Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or
phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days
prior to the first dose of MLN8237

- A medical condition requiring use of pancreatic enzymes; or daily, chronic , or
regular use of proton pump inhibitors (PPI); or histamine (H2) receptor antagonists.
Patients who intermittently use these medications must meet the following:

- No use of PPI within 7 days of first dose of MLN8237

- No use of H2 antagonist or pancreatic enzymes within 24 hours of first dose of

- Patients requiring full systemic anticoagulation

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ratio of geometric mean dose-normalized Cmax and dose-normalized AUC0-tlast of oral solution vs powder in capsule formulations with 90% confidence intervals (CI)

Outcome Description:

To estimate the relative bioavailability of an oral solution of MLN8237 in reference to a powder in capsule (PIC) formulation.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

April 2012

Related Keywords:

  • Advanced Solid Tumors
  • Area under the plasma concentration versus time curve (AUC)
  • Maximum plasma concentration (Cmax)
  • Area under the plasma concentration versus time curve zero to the time of the last quantifiable concentration (AUC0-tlast)
  • Confidence intervals (CI)
  • Time of first observed maximum plasma concentration (Tmax)
  • Neoplasms



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