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Anti-cancer agent

Eflornithine for Anaplastic Astrocytoma (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 4 years
Awards & highlights

STELLAR Trial Summary

This trial is testing whether adding eflornithine to the standard treatment for this cancer will help patients live longer.

Eligible Conditions
  • Anaplastic Astrocytoma

STELLAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
Objective response rate (ORR)
Progression-free survival (PFS)
Other outcome measures
Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria
OS rate at 18 months (OS-18)
PK - Area under the curve (AUC) of eflornithine in plasma will be determined.
+2 more

Side effects data

From 2019 Phase 3 trial • 171 Patients • NCT01483144
21%
nausea
14%
abdominal pain
14%
upper respiratory tract infection
14%
headache
13%
gastroenteritis
13%
abdominal pain upper
13%
diarrhoea
13%
rectal haemorrhage
11%
haematochezia
11%
nasopharyngitis
11%
rash
11%
vomiting
9%
back pain
9%
influenza like illness
9%
flatulence
9%
oropharyngeal pain
7%
dizziness
7%
arthralgia
7%
myalgia
7%
fatigue
7%
influenza
7%
sinusitis
5%
neck pain
5%
pouchitis
5%
cough
5%
gastritis erosive
5%
gastroenteritis viral
5%
small bowel obstruction
5%
pruritus
5%
constipation
5%
dry skin
5%
urticaria
4%
weight increased
4%
small intestinal obstruction
4%
decreased appetite
4%
abdominal distension
4%
dyspepsia
4%
anxiety
4%
alopecia
4%
urinary tract infection
2%
bursitis
2%
pulmonary mass
2%
contusion
2%
wound dehiscence
2%
seroma
2%
ileus
2%
pancreatitis acute
2%
inguinal hernia
2%
seasonal allergy
2%
nasal congestion
2%
insomnia
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

STELLAR 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
~830
Lomustine
2008
Completed Phase 3
~1540

Find a Location

Who is running the clinical trial?

Orbus Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
66 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different facilities are managing this clinical trial?

"This clinical trial has 46 patients enrolled at the moment, with University of Pennsylvania in Philadelphia, Saint Luke's Cancer Institute in Kansas City, and University of California Irvine Medical Center in Orange being a few of the participating locations."

Answered by AI

Are there similar studies that have been done with Eflornithine?

"Eflornithine was first researched in 2003 at the M. D. Anderson Cancer Center. In the last 17 years, there have been a total of 38 clinical studies completed, with 32 more currently underway. Some of the major locations for these active trials include Philadelphia, Pennsylvania."

Answered by AI

Are there any available spots left for this clinical trial?

"According to the information available on clinicaltrials.gov, this study is not currently recruiting patients. The trial was posted on 7/1/2016 and the most recent update was on 1/19/2022. There are 1165 other studies that are currently looking for participants."

Answered by AI

For what reasons is Eflornithine commonly given to patients?

"Eflornithine can be used to treat brain conditions, hair removal therapy, and meningoencephalitic stage trypanosoma brucei gambiense infection."

Answered by AI

Are there any short- or long-term dangers linked to Eflornithine use?

"Eflornithine's safety is based on clinical evidence from Phase 3 trials, and it thus received a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
2016. "Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02796261.
All > Anaplastic Ependymoma > Anaplastic Astrocytoma
~39 spots leftby Apr 2025
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