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NCT02796261 Clinical Trial

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

Anaplastic Astrocytoma Clinical Trial

— STELLAR  

Official title:
A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02796261
Other study ID # OT-15-001
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 2016
Est. completion date June 2023

Study information
Verified date January 2022
Source Orbus Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Description:

This study will consist of 4 study periods of up to 50 months in total, consisting of: Screening Period - A maximum screening duration of 4 weeks. Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months. End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms. Follow-Up Period - Up to approximately 36 months, or until patient death. A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Eflornithine
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
• Lomustine
Lomustine 90 mg/m2 administered orally once every 6 weeks
• Lomustine
Lomustine 110 mg/m2 administered orally once every 6 weeks
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Sponsors (1)
Lead Sponsor Collaborator
Orbus Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria 4 years
Other OS rate at 18 months (OS-18) 18 months
Other Relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples 4 years
Other Pharmacokinetic Analysis - Maximum concentrations (Cmax) of eflornithine in plasma will be determined. 1 Month
Other PK - Area under the curve (AUC) of eflornithine in plasma will be determined. 1 Month
Primary Overall survival 4 years
Secondary Progression-free survival (PFS) 4 years
Secondary Objective response rate (ORR) 4 years
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