Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR)
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|ClinicalTrials.gov Identifier: NCT02796261|
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : November 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Astrocytoma Recurrent Anaplastic Astrocytoma||Drug: Eflornithine Drug: Lomustine||Phase 3|
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 24 months.
A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Eflornithine + Lomustine
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Other Name: DFMO
Lomustine 90 mg/m2 administered orally once every 6 weeks
Active Comparator: Lomustine
Lomustine dosed every 6 weeks
Lomustine 110 mg/m2 administered orally once every 6 weeks
- Overall survival [ Time Frame: 4 years ]
- Progression-free survival (PFS) [ Time Frame: 4 years ]
- Objective response rate (ORR) [ Time Frame: 4 years ]
- Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria [ Time Frame: 4 years ]
- OS rate at 18 months (OS-18) [ Time Frame: 18 months ]
- Relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples [ Time Frame: 4 years ]
- Pharmacokinetic Analysis - Maximum concentrations (Cmax) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]
- PK - Area under the curve (AUC) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796261
|Contact: Marietta Franco, MSfirstname.lastname@example.org|
|Contact: Kathleen Villamejor, BSemail@example.com|
|Study Director:||Marietta Franco, MS||Orbus Therapeutics, Inc.|