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Anti-cancer agent

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

Phase 3
Waitlist Available
Research Sponsored by Orbus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether a combination of two drugs, eflornithine and lomustine, is more effective than lomustine alone for patients with a type of brain cancer that has returned or worsened after standard treatments. Eflornithine aims to stop cancer cells from growing, while lomustine works by damaging their DNA. The study will involve about 340 patients and last several years.

Eligible Conditions
  • Anaplastic Astrocytoma
  • Brain Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 3 trial • 171 Patients • NCT01483144
21%
nausea
14%
abdominal pain
14%
upper respiratory tract infection
14%
headache
13%
abdominal pain upper
13%
gastroenteritis
13%
diarrhoea
13%
rectal haemorrhage
11%
haematochezia
11%
nasopharyngitis
11%
rash
11%
vomiting
9%
flatulence
9%
influenza like illness
9%
back pain
9%
oropharyngeal pain
7%
fatigue
7%
myalgia
7%
arthralgia
7%
dizziness
7%
influenza
7%
sinusitis
5%
constipation
5%
gastritis erosive
5%
pouchitis
5%
small bowel obstruction
5%
gastroenteritis viral
5%
neck pain
5%
cough
5%
pruritus
5%
dry skin
5%
urticaria
4%
small intestinal obstruction
4%
abdominal distension
4%
weight increased
4%
decreased appetite
4%
dyspepsia
4%
anxiety
4%
alopecia
4%
urinary tract infection
2%
seroma
2%
ileus
2%
inguinal hernia
2%
pancreatitis acute
2%
wound dehiscence
2%
bursitis
2%
pulmonary mass
2%
seasonal allergy
2%
contusion
2%
insomnia
2%
nasal congestion
2%
hyperglycaemia
2%
bronchitis
2%
nephritis
2%
renal failure acute
2%
depression
2%
lung adenocarcinoma
2%
ear pain
2%
psychotic disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eflornithine Plus Sulindac
Eflornithine Plus Sulindac Placebo
Sulindac Plus Eflornithine Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Eflornithine + LomustineExperimental Treatment2 Interventions
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
Group II: LomustineActive Control1 Intervention
Lomustine dosed every 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eflornithine
1998
Completed Phase 3
~920
Lomustine
2008
Completed Phase 3
~1750

Find a Location

Who is running the clinical trial?

Orbus Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
66 Total Patients Enrolled
~36 spots leftby Dec 2025
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