CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Lisavanbulin Phase 1 dose escalation portion +1 moredrug
Likely dose
Lisavanbulin Phase 1 dose escalation portion 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02490800
NCT02490800Phase 2Completed
CompareCT.gov

An Open-label Phase 1/2a Study of Oral BAL101553 in Adult Patients With Advanced Solid Tumors and in Adult Patients With Recurrent or Progressive Glioblastoma or High-grade Glioma

Basilea Pharmaceutica·interventional·Posted Jul 7, 2015·Updated Jun 26, 2024

In Brief

A Phase 2 clinical trial evaluating Lisavanbulin Phase 1 dose escalation portion and Lisavanbulin Phase 2a expansion portion for Neoplasms. Completed, enrolled 72 participants across 13 sites in 4 countries.

Detailed Summary

First in human, open-label, dose escalation (Phase I) and expansion study (Phase 2a) of oral lisavanbulin (BAL101553) in adult patients with advanced solid tumors and adult patients with recurrent or progressive glioblastoma (GBM) or high-grade glioma (HGG).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesBelgium, Germany, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 7, 2015
Enrollment StartMay 20, 2015
Primary CompletionSep 30, 2022
Study CompletionNov 24, 2022
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 11.0 years ago

Interventions

Lisavanbulin Phase 1 dose escalation portiondrug

Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 35 mg/day

Lisavanbulin Phase 2a expansion portiondrug

Recommended Phase 2 dose (RP2D) of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.