Status:
COMPLETED
Study of MLN8237 in Participants With Advanced Solid Tumors
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purposes of this study were to estimate the relative (Rel) bioavailability (BA) of an oral solution (OS) formulation of alisertib in reference to a powder-in-capsule (PIC) formulation, to characte...
Detailed Description
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have advanced solid tumors. This study will look at the relative bioavailability (BA) (...
Eligibility Criteria
Inclusion
- Each participant must meet all of the following inclusion criteria to be enrolled in the study:
- 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 participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse
- Male participants 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
- Meet required entry laboratory and organ function levels
Exclusion
- Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female participants 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 alisertib
- Antineoplastic therapy, radiation therapy or any experimental therapy 21 days prior to first dose of alisertib
- Nitrosoureas or mitomycin-C within 6 weeks before the first dose of alisertib.
- Autologous stem cell transplant within 3 months before the first dose of alisertib, 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 alisertib
- 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 alisertib
- A medical condition requiring use of pancreatic enzymes; or daily, chronic , or regular use of proton pump inhibitors (PPI); or histamine (H2) receptor antagonists. Participants who intermittently use these medications must meet the following:
- No use of PPI within 7 days of first dose of alisertib
- No use of H2 antagonist or pancreatic enzymes within 24 hours of first dose of alisertib
- Participants requiring full systemic anticoagulation
Key Trial Info
Start Date :
September 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00962091
Start Date
September 25 2009
End Date
July 1 2014
Last Update
March 12 2019
Active Locations (1)
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1
Premiere Oncology, A Medical Corporation
Santa Monica, California, United States, 90404