Trabectedin + Olaparib for Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of combining trabectedin and olaparib to treat sarcoma, a type of cancer that cannot be surgically removed or has spread. Trabectedin, a chemotherapy drug, stops cancer cells from growing, while olaparib (also known as Lynparza) blocks cell repair pathways to prevent tumor growth. Researchers aim for this combination to shrink or halt the tumor. Individuals with advanced sarcoma who have already undergone at least one chemotherapy treatment might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of trabectedin and olaparib has been tested for safety in patients with advanced illnesses. Some studies found that this combination caused many side effects, indicating high toxicity rates. Specifically, patients with leiomyosarcoma and liposarcoma (types of cancer) did not benefit from the treatment, and side effects were a concern.
Since this trial is in phase 2, researchers continue to study how well patients can handle this treatment. Phase 2 trials generally assess both the effectiveness and safety of a treatment, so more information will become available as the study progresses. Prospective participants should discuss these findings and any potential risks with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Trabectedin and Olaparib for treating sarcomas because it represents a novel approach compared to standard treatments like doxorubicin and ifosfamide. Trabectedin is unique because it targets the DNA of cancer cells directly, interfering with their ability to multiply. Olaparib adds another layer of action by inhibiting a protein involved in DNA repair, which may enhance the cancer-killing effects of Trabectedin. This dual-action approach has the potential to be more effective than existing therapies, particularly for challenging sarcomas like leiomyosarcoma and liposarcoma.
What evidence suggests that trabectedin and olaparib might be effective treatments for sarcoma?
Research has shown that combining the drugs trabectedin and olaparib may help treat advanced sarcomas, a type of cancer. In earlier studies, trabectedin delayed the progression of certain sarcomas. Olaparib, which blocks cancer cell repair, has shown benefits when combined with other treatments. Early results suggest that using these two drugs together might shrink tumors or slow their growth. Although more research is needed, these findings offer hope for people with sarcoma that cannot be surgically removed or has spread. Participants in this trial will receive the combination of trabectedin and olaparib to evaluate its effectiveness in treating various sarcoma histologies.14678
Who Is on the Research Team?
Rashmi Chugh, M.D.
Principal Investigator
University of Michigan Rogel Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults and teens (16+) with advanced sarcoma that can't be surgically removed or has spread. Participants must have tried at least one chemotherapy, which for certain sarcomas includes an anthracycline. They need to have measurable disease, good heart function, and normal blood, kidney, and liver tests. Women who can bear children and men must use birth control during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive trabectedin and olaparib in 21-day cycles for a maximum of 18 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Olaparib
- Trabectedin
Trial Overview
The trial is testing a combination of two drugs: Trabectedin (a chemotherapy drug) and Olaparib (blocks cell repair), to see if they work together to stop tumor growth in patients with advanced sarcoma. It's a phase II study designed to assess how well these tumors respond when both drugs are given.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
There are 2 cohorts. Both cohorts receive the same treatment: * Cohort 1: Leiomyosarcoma and liposarcoma * Cohort 2: Other bone or soft tissue sarcoma histologies Treatment consists of 21-day cycles for a maximum of 18 months.
Olaparib is already approved in European Union, United States for the following indications:
- Breast cancer
- Ovarian cancer
- Fallopian tube cancer
- Peritoneal cancer
- Pancreatic cancer
- Prostate cancer
- Endometrial cancer
- Ovarian, fallopian tube, and primary peritoneal cancer
- Breast cancer
- Prostate cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Janssen Scientific Affairs, LLC
Industry Sponsor
Joaquin Duato
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Citations
1.
aacrjournals.org
aacrjournals.org/clincancerres/article/31/14/2919/763503/A-Phase-II-Multicenter-Trial-of-Trabectedin-inA Phase II Multicenter Trial of Trabectedin in Combination with ...
We conducted a phase II study to assess the efficacy and safety of trabectedin and olaparib in patients with advanced disease.
Therapeutic advances in leiomyosarcoma - PMC
In a uterine LMS specific subset analysis of this phase 3 trial, trabectedin provided a median PFS of 4.0 months compared with 1.5 months for ...
Results of a phase Ib study of olaparib with concomitant ...
Our study aimed to evaluate the safety and potential efficacy of combining olaparib with radiotherapy in soft-tissue sarcoma patients. We present the results ...
Alliance A092104: A randomized phase 2/3 study of ...
Background: Advanced uterine leiomyosarcoma (uLMS) is an aggressive malignancy with poor prognosis. Standard-of-care treatments, including ...
Phase II Study of Olaparib and Temozolomide for Advanced ...
In summary, the combination of olaparib and temozolomide provided encouraging activity in pretreated uLMS, an aggressive sarcoma subtype without an effective ...
A Phase II Multicenter Trial of Trabectedin in Combination with ...
Conclusions: Trabectedin plus olaparib conferred high rates of toxicity and failed to demonstrate ORs in leiomyosarcoma and liposarcoma.
Study Details | NCT03838744 | Randomized Trial in ...
Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a ...
NCT02398058 | Trabectedin Plus Olaparib in Metastatic or ...
This is a Phase 1b, multi-site, open-label, non-randomized clinical trial evaluating the safety, tolerability, and pharmacokinetics of escalating doses of ...
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