CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
BAL101553 +1 moredrug
Likely dose
BAL101553 48-hour intravenous infusion on days 1, 8, and 15 of each 28-day cycle; maximum tolerated dose (MTD)AI-extracted
Key inclusion· 6
  • ✓Age ≥18 years
  • ✓Phase 1: histologically or cytologically confirmed advanced or recurrent solid tumor that has failed standard therapy or has no effective standard therapy available
  • ✓Phase 2a: platinum-resistant/refractory ovarian, fallopian tube, or primary peritoneal cancer (high-grade serous, endometrioid, or carcinosarcoma) or glioblastoma in first relapse
  • ✓Measurable disease (RECIST v1.1 for solid tumors; contrast-enhancing MRI for glioblastoma)
Key exclusion· 11
  • ✕Prior chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks for solid tumors (or unrecovered from side effects)
  • ✕For glioblastoma: radiotherapy within 12 weeks unless new enhancement outside radiation field or histologic confirmation of progression
  • ✕For glioblastoma: prior chemotherapy within 4 weeks or within 6 weeks for nitrosoureas
  • ✕For glioblastoma: surgical resection within 4 weeks or stereotactic/core biopsy within 1 week

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

Search/NCT02895360
NCT02895360Phase 2Completed
CompareCT.gov

An Open-label Phase 1/2a Study of BAL101553 Administered as Intravenous 48-hour Infusions in Adult Patients With Advanced Solid Tumors or Recurrent Glioblastoma

Basilea Pharmaceutica·interventional·Posted Sep 9, 2016·Updated May 10, 2023

In Brief

A Phase 2 clinical trial evaluating BAL101553 and BAL101553 at MTD for Neoplasms. Completed, enrolled 43 participants across 6 sites.

Detailed Summary

Single-agent, open-label, multi-center sequential dose escalation and expansion study of BAL101553, administered as an intravenous (IV) infusion over 48 hours to adults with advanced or recurrent solid tumors or recurrent glioblastoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesSwitzerland
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 9, 2016
Enrollment StartAug 24, 2016
Primary CompletionAug 7, 2020
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.8 years ago

Interventions

BAL101553drug

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; oral capsule daily for one week during Cycle 2 (study days 15-21)

BAL101553 at MTDdrug

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; treatment with maximum tolerated dose (MTD)