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Lurbinectedin + Doxorubicin for Leiomyosarcoma
Study Summary
This trial is studying if the combination of lurbinectedin with doxorubicin is safe and tolerable in people with soft tissue sarcoma. They will also compare the two to see which is more effective in treating leiomyosarcoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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?
Media Library
- I have advanced leiomyosarcoma with no cure through combined treatments.I am not taking strong or moderate drugs that affect enzyme activity.I have had interstitial pneumonitis or pulmonary fibrosis.My hepatitis B virus load is undetectable with treatment.My organs and bone marrow are functioning well.I received palliative radiation therapy within the last week.I am 18 years old or older.I can take care of myself but may not be able to do heavy physical work.I have been diagnosed with cardiomyopathy.My cancer is an advanced leiomyosarcoma with no cure through combined treatments.I have previously been treated with lurbinectedin.I have tissue samples from previous procedures available for testing.My cancer has spread to my brain, but there are exceptions.I had hepatitis C but have been treated and cured.I have had radiation treatment to my pelvis with a dose over 45 Gy.I have taken oral cancer drugs or TKIs recently.I have had chemotherapy within the specified timeframes.My sarcoma is advanced or has spread, and there are no cure-focused treatments left for me.I do not have any uncontrolled illnesses.I have received antibody therapy like nivolumab recently.I have had 2 or fewer chemotherapy treatments for the phase 1b study, and only 1 for the phase 2 study.I have recovered from side effects of previous cancer treatments, except for minor ones.I have previously been treated with anthracycline or trabectedin.I have advanced soft-tissue sarcoma with no cure through combined treatments.
- Group 1: Lurbinectedin + Doxorubicin Phase I
- Group 2: Lurbinectedin + Doxorubicin at RP2D
- Group 3: Doxorubicin Monotherapy
- 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
Are individuals still able to join this experiment?
"Affirmative. The information on clinicaltrials.gov verifies that this medical trial is actively seeking participants, which it began doing since February 4th 2022 and most recently updated the data on February 14th 2022. 62 patients must be enrolled from two different locations for the study to proceed."
What are the desired outcomes of this clinical investigation?
"This clinical trial is slated to run for a maximum of 5 years, with the primary goal being assessing lurbinectedin's Maximum Tolerated Dose (MTD) in conjunction with doxorubicin on patients suffering from advanced soft-tissue sarcoma. Secondary endpoints include Overall Survival Rate Phase 2, Number of Participants Treatment Related Adverse Events as defined by NCI CTCAE v5.0 and Progression Free Survival Phase 1b."
Is this particular medical trial being done for the first time?
"Currently, 368 Lurbinectedin studies are actively being conducted in 1953 cities across 66 countries. In 1997, the pharmaceutical company Alfacell sponsored a study with 300 patients that eventually completed its Phase 3 trial and drug approval process. Since then, 690 research projects have been launched worldwide."
How many participants are actively engaged in this trial?
"Affirmative. Clinicaltrials.gov illustrates that this research endeavour is actively enrolling participants, having been posted on February 4th 2022 and re-edited 14 days later. Across two sites, 62 patients are required for the study's completion."
Are there any related research projects concerning Lurbinectedin?
"Currently, there are 368 studies dedicated to researching Lurbinectedin with 121 being in the advanced Phase 3 stage. Although many of these trails originate from Providence, Rhode island, a total of 23882 locations worldwide are evaluating this medication."
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