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

This study is currently recruiting participants.
Verified October 2017 by Orbus Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02796261
First Posted: June 10, 2016
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Orbus Therapeutics, Inc.
June 3, 2016
June 10, 2016
October 27, 2017
July 2016
June 2019   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: 4 years ]
Same as current
Complete list of historical versions of study NCT02796261 on ClinicalTrials.gov Archive Site
  • Progression-free survival (PFS) [ Time Frame: 4 years ]
  • Objective response rate (ORR) [ Time Frame: 4 years ]
Same as current
  • 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 ]
Same as current
 
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
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
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.

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 280 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Anaplastic Astrocytoma
  • Recurrent Anaplastic Astrocytoma
  • Drug: Eflornithine
    Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
    Other Name: DFMO
  • Drug: Lomustine
    Lomustine 90 mg/m2 administered orally once every 6 weeks
    Other Names:
    • CCNU
    • CeeNU
  • Drug: Lomustine
    Lomustine 110 mg/m2 administered orally once every 6 weeks
    Other Names:
    • CCNU
    • CeeNU
  • Experimental: Eflornithine + Lomustine
    Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
    Interventions:
    • Drug: Eflornithine
    • Drug: Lomustine
  • Active Comparator: Lomustine
    Lomustine dosed every 6 weeks
    Intervention: Drug: Lomustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
280
August 2019
June 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

  • Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
  • Unequivocal evidence of first AA tumor progression or recurrence ≤ 3 months prior to randomization based on MRI criteria for tumor progression using enlarging Gd-contrast enhancement and/or T2 hyperintensity. Patients with non-measurable Gd contrast enhancing tumors will only be eligible if there is no necrosis seen on MRI and/or histopathological confirmation of AA per standard of care procedures is obtained.
  • First tumor progression or recurrence following surgical resection or biopsy, if resection is not feasible, EBRT and temozolomide chemotherapy.
  • Completion of EBRT ≥ 6 months prior to randomization.
  • A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2/FLAIR.
  • Karnofsky Performance Status (KPS) score of ≥ 70.

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not eligible for study participation:

  • MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
  • Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
  • Prior systemic therapy for recurrence of AA.
  • Presence of extracranial or leptomeningeal disease.
  • Prior lomustine use.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
  • Pregnant or breastfeeding.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Marietta Franco, MS 6504506634 marietta.franco@orbustherapeutics.com
Contact: Kathleen Villamejor, BS 6506569424 kathleen.villamejor@orbustherapeutics.com
Belgium,   Canada,   Germany,   Italy,   Netherlands,   United States
 
 
NCT02796261
OT-15-001
Yes
Not Provided
Plan to Share IPD: No
Orbus Therapeutics, Inc.
Orbus Therapeutics, Inc.
Not Provided
Study Director: Marietta Franco, MS Orbus Therapeutics, Inc.
Orbus Therapeutics, Inc.
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP