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Lurbinectedin for Solid Tumors
Study Summary
This trial is testing a new cancer drug, Lurbinectedin, in combination with another cancer drug, irinotecan. The trial will have two parts: first, they will test different doses of the drugs to see what is safe; then, they will expand the trial to include more people.
- Advanced Solid Tumors
- Neuroendocrine Tumors
- Small Cell Lung Cancer
- Stomach Cancer
- Glioblastoma
- Ovarian Cancer
- Endometrial Cancer
- Mesothelioma
- Pancreatic Adenocarcinoma
- Colorectal Cancer
- Soft Tissue Sarcoma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have other health conditions or diseases in addition to the one being studied.You have an extreme sensitivity or allergy to any of the study drugs or their ingredients.You have been treated with lurbinectedin, trabectedin (Yondelis®), or certain types of medications called topoisomerase I inhibitors (irinotecan, topotecan, etc.) in the past.You have cancer that has spread to your brain or the tissues surrounding your brain.You can have received any type of targeted therapy, hormonal therapy, or immunotherapy in the past.If you have glioblastoma, you must have finished radiation treatment at least 12 weeks ago, unless you have a new tumor outside the treated area or have had brain surgery to remove the tumor and the disease has been confirmed to be getting worse by examining the tissue.
- Group 1: Intermediate Escalation Group
- Group 2: Lurbinectedin Escalation Group
- Group 3: Irinotecan Escalation Group
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Would it be possible to join this clinical trial?
"The data available on clinicaltrials.gov suggests that this trial is still enrolling patients. The original posting date was May 6th, 2016 and the most recent update was November 26th, 2021."
What is the previous research on Lurbinectedin's efficacy?
"There are a total of 283 Lurbinectedin studies currently underway, 54 of which are Phase 3 trials. The majority of these active studies are based in Woolloongabba, Queensland; however, there are 8,831 clinical locations running these types of tests worldwide."
What indications does Lurbinectedin commonly address?
"Lurbinectedin is a medication that oncologists often prescribe to patients with colorectal carcinoma. Additionally, it can be effective in treating ovarian cancer, sarcoma, and metastatic colorectal carcinoma."
How many participants are needed for this clinical trial?
"That is correct. The online information on clinicaltrials.gov affirms that this study, which was first advertised on May 6th 2016, is recruiting patients at this time. They are currently looking for 320 individuals total from two different locations."
Why did researchers design this clinical study in this way?
"As stated by the study's sponsor, PharmaMar, the primary goal of this trial is to establish the Maximum Tolerated Dose (MTD) over a 66-month period. Additionally, secondary objectives include evaluating antitumor response, half-life, and clearance."
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