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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No known defect of glutathione metabolism
Bidimensionally measurable disease outside the field of prior radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study the effectiveness of T138067 in treating patients with non-small cell lung cancer that has not responded to previous chemotherapy.
Who is the study for?
Adults with advanced non-small cell lung cancer that hasn't improved after chemotherapy can join this trial. They should have a good performance status, life expectancy of at least 12 weeks, and no severe diseases or infections. Participants need normal organ function tests, not be pregnant or nursing, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of T138067 in patients with advanced non-small cell lung cancer who haven't responded to prior chemo. It's a Phase II study focusing on how well this drug works when other treatments have failed.See study design
What are the potential side effects?
While specific side effects for T138067 are not listed here, common ones from chemotherapy drugs include nausea, fatigue, hair loss, increased risk of infection due to low blood counts, and potential damage to organs like the liver and kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My body's glutathione metabolism works normally.
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My cancer can be measured and is outside the areas previously treated with radiation.
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My cancer has spread beyond its original location.
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I am 18 years old or older.
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I've had taxane as my first and only chemo for advanced cancer.
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My cancer has not spread to my brain or caused meningitis.
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My liver function tests are within normal limits and I don't have Gilbert's syndrome.
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My kidney function, measured by creatinine, is within normal limits.
Select...
My lung cancer is confirmed to be non-small cell type.
Select...
I am mostly able to care for myself and carry out daily activities.
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
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Who is running the clinical trial?
TularikLead Sponsor
6 Previous Clinical Trials
925 Total Patients Enrolled
Sean McCarthyStudy ChairTularik
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on hormonal therapy for my lung cancer.My body's glutathione metabolism works normally.My cancer can be measured and is outside the areas previously treated with radiation.It's been over 4 weeks since my last chemotherapy, 6 for certain types, and I'm not on other cancer-killing drugs.I haven't taken any experimental drugs in the last 4 weeks and I'm not on high-dose acetaminophen or anticonvulsants, unless needed for side effects from study drugs.My cancer has spread beyond its original location.I am 18 years old or older.I am not currently on immunotherapy or certain blood cell boosters.It has been over 4 weeks since my last major surgery.I've had taxane as my first and only chemo for advanced cancer.My cancer has not spread to my brain or caused meningitis.My liver function tests are within normal limits and I don't have Gilbert's syndrome.I haven't had any cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer.I don't have any severe illnesses that would stop me from joining the study.I will use effective birth control during and for 3 months after the study.My kidney function, measured by creatinine, is within normal limits.I haven't had major radiotherapy affecting my bone marrow recently.I have had chemotherapy after my main cancer treatment.My lung cancer is confirmed to be non-small cell type.I am mostly able to care for myself and carry out daily activities.
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.
Are applications presently being accepted for this investigation?
"Clinicaltrials.gov affirms that this study, posted on the 10th of October 2000 and amended January 3rd 2014, is not currently accepting participants. In contrast to this trial though, there are over two-thousand studies actively recruiting patients at present."
Answered by AI
Has this procedure obtained the regulatory approval of the FDA?
"Power has rated the safety of this treatment as a 2 due to its Phase 2 status, where evidence for efficacy is still lacking but there exists some data validating its safety."
Answered by AI
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