NCT00701324: BI 811283 in advanced solid tumors: phase 1 findings

This was a phase 1 dose-escalation study of the Aurora B kinase inhibitor BI 811283 in advanced solid tumors. The original report included 121 treated patients, using two intravenous schedules. Maximum tolerated doses were 125 mg on the twice-per-four-week-cycle schedule and 230 mg on the once-per-three-week-cycle schedule. 1 2

No objective tumor responses were observed. Nineteen patients in each schedule had stable disease, which is not the same as tumor shrinkage or demonstrated survival benefit. Dose-limiting toxicities included febrile neutropenia and grade 4 neutropenia. Other reported treatment-related problems included fatigue, leukopenia, nausea, alopecia, diarrhea, and reduced appetite. 2

The useful result is therefore the drug's early safety/dose characterization and limited observed antitumor activity, not an established treatment advantage. This small, noncomparative phase 1 study could not establish superiority over standard treatment. 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00701324. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00701324. Original study registration: sponsor, design, population, endpoints and dated history.

2. PubMed — Mross et al., original phase 1 report, 2016Research publication · Publication abstract read via Europe PMC; identifier and title cross-checked. Checked 2026-10-10. Full paper was not independently re-read for this update; abstract details should not be extended beyond what it reports.