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Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma

ConditionsGlioblastoma, IDH-wildtypeGlioblastomaGlioblastoma MultiformeGlioblastoma IDH (Isocitrate Dehydrogenase) WildtypeGBMAstrocytomaAstrocytoma, IDH-Mutant
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrbus Therapeutics, Inc.

About this trial

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A/B intact) per WHO 2021 tumor classification.

Completed external beam radiation therapy per standard of care.

Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.

Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.

Disqualifiers

Recent history of recurrent or metastatic cancer that could confound response assessments

Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).

Prior Optune treatment.

Active infection or serious intercurrent medical illness.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Eflornithine (Dose Level 1)

    Drug

    Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

  • Eflornithine (Dose Level 2)

    Drug

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

  • Eflornithine (Dose Level -1)

    Drug

    Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

  • Temozolomide

    Drug

    Temozolomide 150 mg/m2 (with option to escalate per USPI maintenance phase instructions) administered orally once daily on a 5 days on, 23 days off schedule

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Eflornithine Dose Level 1 + TemozolomideExperimental treatment 2 interventions
Group B: Eflornithine Dose Level 2 + TemozolomideExperimental treatment 2 interventions
Group C: Eflornithine Dose Level -1 + TemozolomideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Assessment of Dose Limiting Toxicities

Protocol Defined Dose Limiting Toxicities

Time frame
8 weeks
2

Incidence of TEAEs All Grades

All Grades

Time frame
From enrollment to the follow-up visit 4 weeks after end of treatment
3

Incidence of TEAEs Grade 3+

Grade 3+

Time frame
From enrollment to the follow-up visit 4 weeks after end of treatment
4

Incidence of TEAEs Serious

Serious

Time frame
From enrollment to the follow-up visit 4 weeks after end of treatment

Secondary outcomes

1

Overall Survival

Until death or initiation of new anticancer therapy

Time frame
From enrollment to up to 2 years after last dose
2

Progression Free Survival

Per RANO Criteria as assessed by MRI

Time frame
From enrollment to the follow-up visit 4 weeks after end of treatment
3

Overall Response Rate

Per RANO Criteria as assessed by MRI

Time frame
From enrollment to the follow-up visit 4 weeks after end of treatment
4

Pharmacokinetics Cmax

observed maximum concentration

Time frame
Baseline to Steady State (2 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orbus Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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