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CompletedNCT04740190

Talazoparib - Carboplatin for Recurrent High-grade Glioma With DDRd

Combination Talazoparib - Carboplatin for Recurrent High-grade Glioma With DNA Damage Repair Deficiency (DDRd)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
33 (actual)
Sponsor
The University of Hong Kong · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

In view of the strong biological rationale of employing PARP inhibition in high grade glioma, the current study purposes testing of talazoparib in a biomarker-enriched group of glioma. Carboplatin will be added to sensitize the tumor to PARP inhibition, and low dose radiation therapy will be applied to increase talazoparib drug penetration through blood-brain barrier. The goal is to estimate the effect size of such combinational treatment approach in recurrent high-grade glioma with DNA damage repair deficiency (dDDR)

Detailed description

Recurrent high grade glioma with dDDR, defined by genomic aberrations associated including IDH mutation, PTEN mutation and "BRCAness" signature as defined by next-generation-sequencing (NGS) based comprehensive genomic profiling, will be enrolled. Patients will receive treatment in 7-day cycle. D1-4: Oral talazoparib 0.75mg daily; D1: Carboplatin (AUC 1.5). On cycle 1 day 1 low dose whole radiation radiation therapy will be given to increase drug penetration. Primary outcome is 6-month progression free survival (PFS-6) by RANO criteria. The study intended to recruit 33 subjects

Conditions

Interventions

TypeNameDescription
DRUGTalazopariblow dose whole brain radiation, followed by combination talazoparib and carboplatin

Timeline

Start date
2021-01-01
Primary completion
2023-12-14
Completion
2023-12-14
First posted
2021-02-05
Last updated
2025-06-11

Locations

1 site across 1 country: Hong Kong

Regulatory

Source: ClinicalTrials.gov record NCT04740190. Inclusion in this directory is not an endorsement.