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Monoclonal Antibodies
Lurbinectedin + Paclitaxel + Bevacizumab for Ovarian Cancer
Phase 1
Recruiting
Led By Shannon Westin, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial will study if adding a new drug to existing cancer treatments can help advanced cancer patients.
Who is the study for?
This trial is for adults with ovarian, fallopian tube, or peritoneal carcinoma that's resistant to platinum-based treatments. Participants must be in good physical condition (ECOG 0-1), have had any number of prior therapies but no recent anti-cancer treatments, and not be pregnant or breastfeeding. They should not have serious heart issues, uncontrolled infections, significant bleeding disorders, or known allergies to the drugs being tested.Check my eligibility
What is being tested?
The study tests if adding lurbinectedin to paclitaxel and bevacizumab can better control advanced ovarian cancer. It's a Phase 1b trial which means it’s early in testing this combination treatment and focuses on safety and how well patients tolerate the drug mix.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, increased risk of infection due to immune system suppression by chemotherapy drugs like paclitaxel and lurbinectedin; high blood pressure or bleeding from bevacizumab; nerve damage; fatigue; gastrointestinal complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation and Dose ExpansionExperimental Treatment3 Interventions
Pariticipants will be assigned to a dose level of combined paclitaxel, bevacizumab, and lurbinectedin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lurbinectedin
2022
Completed Phase 2
~90
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,251 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,312 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,711 Patients Enrolled for Ovarian Cancer
Shannon Westin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
439 Total Patients Enrolled
2 Trials studying Ovarian Cancer
71 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart condition is unstable.I have not had major surgery in the last 4 weeks.I have been treated with anti-VEGF therapy for platinum-resistant cancer.I haven't had cancer treatment like radiation or chemotherapy in the last 2 weeks.I am fully active or can carry out light work.I have a wound, ulcer, or bone fracture that is not healing.I am 18 years old or older.I have a history or current infection of hepatitis or HIV.I do not have any serious mental or physical health issues that could affect my treatment.I do not have severe nerve damage in my hands or feet.I have had multiple treatments for my condition.My organs and bone marrow are functioning well.I am willing and able to follow the study's treatment plan and attend all visits.I haven't taken any cancer drugs or experimental drugs in the last 28 days or less.I am not on any cancer treatment except for steroids.I have coughed up blood in the past month.I am allergic to lurbinectedin, paclitaxel, bevacizumab, or their ingredients.I have a condition that could worsen stomach or intestine problems.I am post-menopausal or not currently pregnant.I have brain lesions that are causing symptoms.My cancer is in the ovary, fallopian tube, or peritoneum and doesn't respond well to platinum treatment. I haven't had anti-VEGF with chemo for this condition.I do not have an active infection needing IV drugs.I haven't had any bleeding issues or ulcers in the last month.I am using effective birth control methods and have a negative pregnancy test if applicable.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation and Dose Expansion
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.
Have the FDA issued a license for Dose Escalation and Dose Expansion?
"Our experts at Power have assigned Dose Escalation and Dose Expansion a safety rating of 1 due to the limited evidence in Phase One trials that suggests efficacy for this intervention."
Answered by AI
Is there still time to partake in the experiment?
"As noted on clinicaltrials.gov, this medical trial has already ceased recruiting patients; the first post was made on May 31st 2023 and its last update occurred November 23rd 2022. Notwithstanding, 678 other studies are still actively seeking participants at present moment."
Answered by AI
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