ABT-348 as Monotherapy or Combination With Carboplatin or Docetaxel to Treat Advanced Solid Tumors

Phase 1 Completed 102 enrolled AbbVie

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel.

Timeline

Start: 2010-03
Primary completion: 2013-09
Completion: 2013-09

Publications

Maitland ML, Piha-Paul S, Falchook G, Kurzrock R, Nguyen L, Janisch L, Karovic S, McKee M, Hoening E, Wong S, Munasinghe W, Palma J, Donawho C, Lian GK, Ansell P, Ratain MJ, Hong D. Clinical pharmacodynamic/exposure characterisation of the multikinase inhibitor ilorasertib (ABT-348) in a phase 1 dose-escalation trial. Br J Cancer. 2018 Apr;118(8):1042-1050. doi: 10.1038/s41416-018-0020-2. Epub 2018 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Ilorasertib	Small molecule	8 mg	Oral
Subject	Ilorasertib	Small molecule	10 mg	Oral
Subject	Ilorasertib	Small molecule	32 mg	Oral
Subject	Ilorasertib	Small molecule	40 mg	Oral
Subject	Ilorasertib	Small molecule	180 mg	Oral
Subject	Ilorasertib	Small molecule	340 mg	Oral

ABT-348 as Monotherapy or Combination With Carboplatin or Docetaxel to Treat Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications