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

NCT02796261 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2022-01-21

No results posted yet for this study

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.

Conditions

  • Anaplastic Astrocytoma
  • Recurrent Anaplastic Astrocytoma

Interventions

DRUG

Eflornithine

Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule

DRUG

Lomustine

Lomustine 90 mg/m2 administered orally once every 6 weeks

DRUG

Lomustine

Lomustine 110 mg/m2 administered orally once every 6 weeks

Sponsors & Collaborators

  • Orbus Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

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

Study Locations

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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 NCT02796261 on ClinicalTrials.gov