Advanced Solid Tumors Clinical Trial
Official title:
Pharmacokinetics of Oral Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function
The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment on the single-dose pharmacokinetics of alisertib in adult participants with cancer.
The drug being tested in this study is called alisertib. Alisertib was tested to assess how
it was processed by the body in participants with advanced solid tumors or
relapsed/refractory lymphoma with varying degrees of liver function. This study also assessed
laboratory results and safety.
The study enrolled 36 participants. Participants were assigned to 1 of the 3 treatment groups
based on the status of their liver function: Normal hepatic function (Total bilirubin ≤ upper
limit of the normal range [ULN] and alanine aminotransferase [ALT] level ≤ ULN), moderate
hepatic impairment (Total bilirubin > 1.5-3 x ULN and ALT level = Any), or severe hepatic
impairment (Total bilirubin > 3 x ULN and ALT level = Any). All participants were
administered one 50 mg dose of alisertib on Day 1, Cycle 1. Alisertib was administered again
on Days 8 through 14 of Cycle 1, followed by a 14-day rest period. Doses administered on Days
8-14 were 50, 30, or 20 mg of alisertib, depending on hepatic function. Alisertib was then
continued at the same dose as in Cycle 1, Days 8-14 in 21-day cycles (7 days of alisertib
followed by a 14-day rest period) for up to 1 year (approximately 16 cycles).
This multicenter trial was conducted in USA only. The overall time to participate in this
study was up to 312 Days. Participants made multiple visits to the clinic including an
end-of-study visit 30 days after the last dose of study drug for a follow-up assessment.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04972981 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT05086822 -
A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03260322 -
A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT06040541 -
Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05862831 -
Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03641794 -
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT03665129 -
IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06413680 -
A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05914116 -
A Study of DB-1311 in Advanced/Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01693562 -
A Phase 1/2 Study to Evaluate MEDI4736
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04387916 -
A Study of KC1036 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT04095273 -
Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug
|
Phase 1 | |
| Not yet recruiting |
NCT03692520 -
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02997176 -
An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
|
Phase 1 | |
| Recruiting |
NCT04446260 -
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT02253992 -
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06076291 -
An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03545971 -
A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.
|
Phase 1 |