ilorasertib (ABT348) / AbbVie - LARVOL DELTA

Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors (clinicaltrials.gov) - P2 | N=12 | Terminated | Sponsor: M.D. Anderson Cancer Center | Completed ➔ Terminated; Study terminated due to company's decision to discontinue drug development

Trial termination • Oncology • Solid Tumor • CDKN2A

Pharmaco-kinetics/dynamics (PK/PD) evaluation and individual patient cross-over studies with growth trajectory assessment to adaptively develop ilorasertib. (ASCO 2017) - P1; "The development plan adapted to the in-human PK/PD assessment. We prospectively conducted individual change-in-tumor burden cross-over studies to assess clinically the sensitivity of CDKN2A-deficient tumors."

Biosimilar • Oncology

Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Completed

Pan tumor • Trial completion • Oncology • Solid Tumor • CDKN2A

ABT-348 as monotherapy and in combination with azacitidine to treat advanced hematologic malignancies (clinicaltrials.gov) - P1, N=58; Sponsor: AbbVie (prior sponsor, Abbott); Recruiting; Completion date: Jan 2013 -> Sep 2013.

Trial completion date • Acute Myelogenous Leukemia • Oncology

ABT-348 as monotherapy and in combination with azacitidine to treat advanced hematologic malignancies (clinicaltrials.gov) - P1, N=52; Sponsor: AbbVie; Active, not recruiting -> Completed. 

Trial completion • Hematological Malignancies • Oncology

Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors (clinicaltrials.gov) - P2; N=65; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center; Initiation date: Dec 2015 ➔ Aug 2016; Trial primary completion date: Dec 2021 ➔ Aug 2022

Trial initiation date • Trial primary completion date • Biosimilar • Oncology

Clinical pharmacodynamic/exposure characterisation of the multikinase inhibitor ilorasertib (ABT-348) in a phase 1 dose-escalation trial. (PubMed, Br J Cancer) - P1; "In patients with advanced solid tumours, ilorasertib treatment resulted in evidence of engagement of the intended targets and antitumour activity, but with maximum inhibition of VEGFR family kinases occurring at lower exposures than typically required for inhibition of Aurora B in tissue."

Clinical • Journal • P1 data • PK/PD data

Ilorasertib in Treating Patients With CDKN2A-deficient Advanced or Metastatic Solid Cancers That Cannot Be Removed by Surgery (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: University of Chicago; Active, not recruiting ➔ Completed; Trial completion date: Oct 2018 ➔ Feb 2019; Trial primary completion date: Jun 2018 ➔ Feb 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date