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Investigation of Oral OKN-007 in Recurrent High-grade Glioma Participants

NCT03649464 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-10-07

No results posted yet for this study

Summary

The objective of this study is to investigate tolerability, safety, pharmacokinetics (PK) and efficacy of oral OKN-007 in participants with recurrent high-grade glioma.

Conditions

Interventions

DRUG

OKN-007

Dose escalation/PK cohort (Phase Ib): 1000mg twice daily (BID), 1000mg thrice daily (TID), 1500mg thrice daily (TID). Expansion cohort (Phase 2): MTD defined in the dose escalation (Phase Ib) study.

Sponsors & Collaborators

  • Oblato, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2025-04-30
Completion
2025-08-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649464 on ClinicalTrials.gov