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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 : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Orbus Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 3, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date March 15, 2019
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
Overall survival [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02796261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
  • Progression-free survival (PFS) [ Time Frame: 4 years ]
  • Objective response rate (ORR) [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2016)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
Official Title  ICMJE 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
Brief 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.
Detailed 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anaplastic Astrocytoma
  • Recurrent Anaplastic Astrocytoma
Intervention  ICMJE
  • 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
    • Gleostine
  • Drug: Lomustine
    Lomustine 110 mg/m2 administered orally once every 6 weeks
    Other Names:
    • CCNU
    • CeeNU
    • Gleostine
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
340
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2016)
280
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:

    1. Gd-contrast lesion margins are not clearly defined,
    2. Gd-contrast lesions are only measurable in one dimension,
    3. Gd-contrast lesion has two perpendicular diameters less than 10 mm,
    4. Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
    5. Recent histopathological confirmation of WHO grade 3 AA
  • Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marietta Franco, MS 6504506634 marietta.franco@orbustherapeutics.com
Contact: Kathleen Villamejor, BS 6506569424 kathleen.villamejor@orbustherapeutics.com
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796261
Other Study ID Numbers  ICMJE OT-15-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Orbus Therapeutics, Inc.
Study Sponsor  ICMJE Orbus Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marietta Franco, MS Orbus Therapeutics, Inc.
PRS Account Orbus Therapeutics, Inc.
Verification Date March 2019

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