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Tyrosine Kinase Inhibitor
Erlotinib for Glioblastoma
Phase 2
Waitlist Available
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen
Age 18 and over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well erlotinib works in treating patients with recurrent or progressive glioblastoma multiforme.
Who is the study for?
This trial is for adults with glioblastoma multiforme that has come back or gotten worse. They should have already tried radiotherapy and chemotherapy, be able to take pills, not pregnant/nursing, use birth control if they can have kids, and have no other serious medical issues or infections.Check my eligibility
What is being tested?
The trial is testing Erlotinib's ability to block enzymes that help cancer cells grow in patients with recurrent or progressive glioblastoma multiforme. It's a Phase II study which means it focuses on the drug’s effectiveness.See study design
What are the potential side effects?
Erlotinib may cause side effects like rash, diarrhea, loss of appetite, fatigue, difficulty breathing and coughing. Liver function might also be affected leading to increased liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had radiation and at least one chemotherapy treatment before.
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I am 18 years old or older.
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My bilirubin levels are not more than twice the normal range.
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I have been diagnosed with glioblastoma multiforme.
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I do not have any current infections.
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My cancer has shown signs of growing or coming back on scans.
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I can take medications by mouth without any issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling
Efficacy of tumor EGFR amplification in predicting response to treatment
Overall survival
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Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,363,945 Total Patients Enrolled
Michael A. Vogelbaum, MD, PhDStudy ChairThe Cleveland Clinic
4 Previous Clinical Trials
803 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not receiving any other cancer treatments.My cancer recurrence was confirmed through a biopsy.I can take medications by mouth without any issues.I've had radiation and at least one chemotherapy treatment before.I am 18 years old or older.My bilirubin levels are not more than twice the normal range.I have been diagnosed with glioblastoma multiforme.I don't have any health or mental conditions that would stop me from joining the study.I do not have any current infections.I haven't had any cancer except for certain skin cancers or cervical cancer in the last 3 years.I have never taken EGFR inhibitor medication.I am not currently taking any EGFR inhibitor medications.I am not taking any seizure medications except for ones like Gabapentin or Lamotrigine.My cancer has shown signs of growing or coming back on scans.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risk factors should be considered when evaluating this treatment?
"Drawing on available data, our team at Power has assigned a score of 2 in terms of safety to this treatment. This is due to it being part of Phase 2 trials which have some clinical evidence attesting its security but none affirming efficacy."
Answered by AI
Are there opportunities for participants to enroll in this experiment?
"Clinicaltrials.gov reveals that this clinical trial has ceased to recruit participants, having been first posted on August 1st 2002 and most recently updated January 9th 2014. Luckily, there are 544 other studies actively seeking enrolment now."
Answered by AI
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