SarcomaPhase 2NCT04076579
Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
A Phase 2 study testing Olaparib and Trabectedin in people with Sarcoma and Sarcoma Metastatic, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sarcoma, Sarcoma Metastatic
- What is being tested?
- Olaparib and Trabectedin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2020to 26 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years
- Advanced unresectable or metastatic sarcoma
- Cohort 1: Leiomyosarcoma (LMS)/Liposarcoma (LPS)
- Cohort 2: Other sarcoma histologies (excluding gastrointestinal stromal tumors)
- Received at least 1 prior standard chemotherapy. For cohort 1 patients, this must have included a prior anthracycline.
- Measurable disease by RECIST 1.1
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- Adequate hematologic, renal, hepatic function
- Adequate creatine phosphokinase
- ECOG performance status ≤ 1
- Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (LLN)
- Women of childbearing potential and men must agree to use adequate contraception from signing informed consent to at least 6 months (females) and 5 months (men) after study drug treatment
Who cannot join
- Prior therapy with PARP inhibitor, including olaparib
- Prior therapy with trabectedin
- Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years
- Pregnant or breastfeeding women
- Known hypersensitivity to trabectedin or olaparib
- Other exclusions per protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.
- Conditions
- Sarcoma, Sarcoma Metastatic
- Being tested
- Olaparib, Trabectedin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Olaparib taken by mouth twice daily
TrabectedinDrug
Trabectedin administered intravenously (IV) every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Olaparib + Trabectedin | Experimental | 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. Receives: Drug: Olaparib; Drug: Trabectedin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.
Measured: Up to 2 years
Secondary outcomes (4)
Progression Free Survival
Defined as the duration of time from start of treatment to time of progression. Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median and 6-month PFS will be estimated along with their 95% confidence intervals.
Measured: At 6 months
Progression Free Survival
Defined as the duration of time from start of treatment to time of progression. Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. reported as survival probability estimates
Measured: At 1 year after enrollment
Overall Survival
Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median, 1- and 2-year OS probability estimates will be estimated along with their 95% confidence intervals.
Measured: At 2 years after enrollment
Incidence of Adverse Events
The frequency and rates of adverse events occurring in at least 5% of participants and rates of grade 3-5 adverse events will be tabulated by system organ class and preferred term using Common Terminology Criteria of Adverse Events (CTCAE), within each cohort.
Measured: Up to 30 days after end of treatment, and average of 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start17 Mar 2020
- Primary completion30 Jan 2023
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Rashmi Chugh, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076579
- Sponsor's protocol ID
- UMCC 2018.132
- Other IDs
- HUM00161251
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2019
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
- ClinicalTrials.gov ID
- NCT04076579
- Acronym / sponsor ID
- UMCC 2018.132
- Conditions
- Sarcoma, Sarcoma Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, AstraZeneca
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olaparib + Trabectedin | Experimental | Drug: Olaparib, Drug: TrabectedinThere 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 16 years
- Advanced unresectable or metastatic sarcoma
- Received at least 1 prior standard chemotherapy. For cohort 1 patients, this must have included a prior anthracycline.
- Measurable disease by RECIST 1.1
- Adequate hematologic, renal, hepatic function
Key exclusion criteria (6 listed)
- Prior therapy with PARP inhibitor, including olaparib
- Prior therapy with trabectedin
- Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years
- Pregnant or breastfeeding women
- Known hypersensitivity to trabectedin or olaparib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaparibOlaparib taken by mouth twice daily | Drug | Olaparib + Trabectedin |
| TrabectedinTrabectedin administered intravenously (IV) every 21 days | Drug | Olaparib + Trabectedin |
Primary outcome
Overall Response Rate
Time frame: Up to 2 years
Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.
4 secondary outcomes
Progression Free Survival
Time frame: At 6 months
Progression Free Survival
Time frame: At 1 year after enrollment
Overall Survival
Time frame: At 2 years after enrollment
Incidence of Adverse Events
Time frame: Up to 30 days after end of treatment, and average of 4.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashmi Chugh, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaparib and Trabectedin in people with Sarcoma and Sarcoma Metastatic, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.