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Enzyme Depletion
ADI-PEG 20 + Gemcitabine + Docetaxel for Lung Cancer
Phase 1 & 2
Recruiting
Led By Brian A Van Tine, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with NSCLC with a driver mutation (EGFR, ALK, ROS1) must have been treated with an FDA approved targeted therapy and subsequent platinum doublet therapy, if eligible
Normal bone marrow and organ function as defined below:
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough the first 4 weeks of treatment for all phase i enrolled participants (estimated to be 12 months and 4 weeks)
Awards & highlights
No Placebo-Only Group
Study Summary
This trial tests a 3-drug combo to treat lung cancer that has progressed on frontline treatment; first, a phase I will test different doses, then phase II will use the recommended dose to assess efficacy.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have advanced stage lung cancer that has spread and did not respond to initial treatment. Your doctor thinks you are suitable for treatment with gemcitabine and docetaxel.
Select...
If you have a certain type of lung cancer without a specific gene mutation, you must have already received a certain type of treatment as your first option.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through the first 4 weeks of treatment for all phase i enrolled participants (estimated to be 12 months and 4 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the first 4 weeks of treatment for all phase i enrolled participants (estimated to be 12 months and 4 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Non-Small Cell Lung Carcinoma
Recommended phase II dose (Phase I only)
Therapeutic procedure
Secondary outcome measures
Non-Small Cell Lung Carcinoma
Non-Small Cell Lung Carcinoma
Non-Small Cell Lung Carcinoma
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxelExperimental Treatment3 Interventions
ADI-PEG 20 is given as an intramuscular injection on a weekly basis (Day 1, 8 and 15) at a dose of 36 mg/m^2. ADI-PEG 20 dosing will start one week prior to the initiation of gemcitabine + docetaxel on Day -7 prior to the initiation of Cycle 1.
Gemcitabine is given intravenously at the assigned dose level on Day 2 of each cycle.
Docetaxel is given intravenously at the assigned dose level on Day 1 of each cycle.
A cycle is defined as 21 days.
After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) per physician discretion or patient request.
Treatment may continue for up to 34 cycles.
Group II: Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxelExperimental Treatment3 Interventions
ADI-PEG 20 is given as an intramuscular injection on a weekly basis (Day 1, 8 and 15) at a dose of 36 mg/m^2. ADI-PEG 20 dosing will start one week prior to the initiation of gemcitabine + docetaxel on Day -7 prior to the initiation of Cycle 1.
Gemcitabine is given intravenously at the assigned dose level on Day 2 of each cycle.
Docetaxel is given intravenously at the assigned dose level on Day 1 of each cycle.
A cycle is defined as 21 days.
After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) per physician discretion or patient request.
Treatment may continue for up to 34 cycles.
Group III: Phase I: ADI-PEG + gemcitabine + docetaxelExperimental Treatment3 Interventions
ADI-PEG 20 is given as an intramuscular injection on a weekly basis (Day 1, 8 and 15) at a dose of 36 mg/m^2. ADI-PEG 20 dosing will start one week prior to the initiation of gemcitabine + docetaxel on Day -7 prior to the initiation of Cycle 1.
Gemcitabine is given intravenously at the assigned dose level on Day 2 of each cycle.
Docetaxel is given intravenously at the assigned dose level on Day 1 of each cycle.
A cycle is defined as 21 days.
After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) per physician discretion or patient request.
Treatment may continue for up to 34 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADI-PEG 20
2013
Completed Phase 2
~190
Gemcitabine
2017
Completed Phase 3
~2070
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,900 Previous Clinical Trials
2,280,849 Total Patients Enrolled
Polaris GroupIndustry Sponsor
24 Previous Clinical Trials
3,179 Total Patients Enrolled
Brian A Van Tine, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
238 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had skin cancer (basal cell or squamous cell carcinoma) that was removed with surgery only.You are currently taking any experimental medications.You have previously been treated with ADI-PEG 20 or gemcitabine, but prior treatment with docetaxel is allowed.You have had allergic reactions to drugs that are similar to ADI-PEG 20, gemcitabine, or pegylated compounds used in the study.You have a history of seizures that are not caused by your cancer.You have moderate or severe nerve damage (neuropathy).You have advanced stage lung cancer that has spread and did not respond to initial treatment. Your doctor thinks you are suitable for treatment with gemcitabine and docetaxel.You have had a previous cancer, but there are some types of cancer that are allowed.You have other types of tumors that have been discussed with the study doctor.You have brain metastases that have not been treated or are not stable. If you have received treatment for your brain metastases and they are not getting worse, you can still participate in the study.If you have a certain type of lung cancer without a specific gene mutation, you must have already received a certain type of treatment as your first option.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: ADI-PEG + gemcitabine + docetaxel
- Group 2: Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
- Group 3: Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
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 patients currently being signed up for this clinical trial?
"The clinical trial in question is no longer recruiting patients, as indicated by its last update on November 14th, 2022. However, out of the 2210 other trials seeking participants, this one was initially posted most recently on January 31st, 2023."
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