A Study of Alisertib (MLN8237) in Adult East Asian Patients With Advanced Solid Tumors or Lymphomas
This is an open-label, multicenter, phase 1 study of alisertib in East Asian patients (eg, patients from countries including but not limited to Singapore, Hong Kong, Taiwan, and South Korea) with either relapsed or refractory advanced solid tumors or lymphomas for which no effective standard treatment is available.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Dose Escalation and Pharmacokinetic Study of Alisertib (MLN8237), an Aurora A Kinase Inhibitor, in Adult East Asian Patients With Advanced Solid Tumors or Lymphomas|
- Number of adverse events, serious adverse events, assessments of clinical laboratory values and clinically important abnormalities, and vital sign measurements [ Time Frame: From start of study to 30 days after the last dose of study drug; approximately 12 months ] [ Designated as safety issue: Yes ]Safety profile and maximum tolerated dose (MTD) of alisertib; and to determine the recommended phase 2 dose of alisertib
- PK parameters, including, but not limited to Cmax, AUC0-t, steady-state apparent oral clearance (CLss/F), terminal half-life (t1/2), accumulation ratio (Rac) and peak-to-trough ratio (PTR) [ Time Frame: Cycle 1: Days 1,3,5,7,8,9,10,11, 13 and Cycle 2: Day 8 ] [ Designated as safety issue: No ]Pharmacokinetics of alisertib
- Objective response rate (ORR) [ Time Frame: At completion of Cycle 2 and every 2 cycles for up to 12 months or until progressive disease ] [ Designated as safety issue: No ]Based on investigator's assessment using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (solid tumors) or modified 2007 International Working Group (IWG) criteria (lymphomas)
- Duration of response [ Time Frame: First documented response until disease progression; approximately 12 months ] [ Designated as safety issue: No ]Based on investigator's assessment using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (solid tumors) or modified 2007 International Working Group (IWG) criteria (lymphomas)
- Concentrations of relevant tumor markers [ Time Frame: Cycle 1, Day 1; at end of Cycle 2 and every 2 cycles thereafter; and at end treatment; approximately 12 months ] [ Designated as safety issue: No ]Measurement of tumor markers (eg PSA, CA-125) from blood sample, if applicable.
|Study Start Date:||February 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Alisertib will be given orally twice daily for 7 consecutive days followed by a 14-day rest period (cycle length = 21 days). If, at the end of 14 days of rest, all alisertib-related toxicities (except alopecia) have not resolved to less than Grade 2, the cycle will be extended to a maximum of 28 days (ie, additional 7-day rest period). Patients will continue to receive repeated cycles of alisertib treatment for as long as their disease has not progressed and they have not experienced unacceptable alisertib-related toxicity.
Other Name: MLN8237