NCT01714947

Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib

Mass Balance, Pharmacokinetics, and Metabolism of [^14C]-Alisertib in Patients With Advanced Solid Tumors or Lymphomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity \[TRA\] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.

Detailed description

The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat participants who have advanced solid tumors or lymphomas. This study looked at mass balance, pharmacokinetics (PK), metabolism, elimination and safety of alisertib. The study enrolled 3 patients. The study consisted of 2 parts: Part A and Part B. Participants received: * \[\^14C\]-alisertib 35 mg in Part A * alisertib 50 mg in Part B Participants were asked to take a single dose of \[\^14C\]-alisertib oral solution containing 80-100 μCi of total radioactivity (1.19-1.48 mCi/mmol) in Part A and alisertib 50 mg, orally, twice daily for 7 days in 21-day cycles until disease progression or unacceptable toxicity in Part B. This single center trial was conducted in United States. The overall time to participate in this study was up to 117 days. Participants remained confined to clinic in Part A and made multiple visits to the clinic in Part B. Participants were contacted 30 days after last dose of alisertib in Part A (if not continuing in Part B), or were contacted by telephone or a final visit 30 days after receiving their last dose of alisertib in Part B for a follow-up assessment.

Conditions

• Advanced Solid Tumors
• Lymphoma

Interventions

Type	Name	Description
DRUG	[^14C]-alisertib	\[\^14C\]-alisertib oral solution
DRUG	alisertib	Alisertib enteric coated tablets

Timeline

• Start date: 2013-01-24
• Primary completion: 2013-04-04
• Completion: 2013-06-14
• First posted: 2012-10-26
• Last updated: 2018-10-31
• Results posted: 2018-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study