Trial Outcomes & Findings for Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma (NCT NCT04076579)

Last Updated: 2025-08-29

Results Overview

Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2025-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Cohort 2 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days
Overall Study STARTED	16	13
Overall Study COMPLETED	12	9
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Cohort 2 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days
Overall Study Adverse Event	2	0
Overall Study discontinued due to toxicity	1	0
Overall Study Physician Decision	1	0
Overall Study Patient was deemed ineligible before starting study treatment	0	1
Overall Study Noncompliance	0	1
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=16 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Cohort 2 n=13 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: one patient in cohort 2 was not evaluable

Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.

Outcome measures

Outcome measures
Measure	Cohort 1 n=16 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Cohort 2 n=12 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days
Overall Response Rate	0 Participants	2 Participants

SECONDARY outcome

Timeframe: At 6 months

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=16 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Cohort 2 n=12 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days
Progression Free Survival	4.1 months Interval 3.3 to not reportable per biostatistician. The "NA" values appear because the upper confidence limit for the median could not be estimated. The upper confidence limit requires the upper confidence bound of the survival curve to fall below 50 percent. If it remains above 50 percent throughout follow-up, the upper limit cannot be estimated and will be reported as "NA" or "NE." This is what happened here.	3.8 months Interval 2.2 to not reportable per biostatistician. The "NA" values appear because the upper confidence limit for the median could not be estimated. The upper confidence limit requires the upper confidence bound of the survival curve to fall below 50 percent. If it remains above 50 percent throughout follow-up, the upper limit cannot be estimated and will be reported as "NA" or "NE." This is what happened here.

SECONDARY outcome

Timeframe: At 1 year after enrollment

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

Outcome measures

Outcome measures
Measure	Cohort 1 n=16 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Cohort 2 n=12 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days
Progression Free Survival	8.9 percentage of patients	20.2 percentage of patients

SECONDARY outcome

Timeframe: At 2 years after enrollment

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=16 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Cohort 2 n=12 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days
Overall Survival 1 year post enrollment	0.52 probability estimates Interval 0.28 to 0.94	0.48 probability estimates Interval 0.24 to 0.94
Overall Survival 2 year post enrollment	0 probability estimates Interval 0.0 to 0.0	0.12 probability estimates Interval 0.02 to 0.74

SECONDARY outcome

Timeframe: Up to 30 days after end of treatment, and average of 4.5 months

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=16 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Cohort 2 n=14 Participants Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days
Incidence of Adverse Events White blood cell decreased- Grade 3	11 number of events	1 number of events
Incidence of Adverse Events White blood cell decreased- Grade 4	4 number of events	1 number of events
Incidence of Adverse Events Acute Kidney Injury- Grade 3	0 number of events	1 number of events
Incidence of Adverse Events Alanine aminotransferase increased- Grade 3	1 number of events	3 number of events
Incidence of Adverse Events Anemia- Grade 3	5 number of events	1 number of events
Incidence of Adverse Events Aspartate aminotransferase increased - Grade 3	1 number of events	1 number of events
Incidence of Adverse Events Blood bilirubin increased- Grade 3	1 number of events	0 number of events
Incidence of Adverse Events Bronchopulmonary hemorrhage - Grade 3	0 number of events	1 number of events
Incidence of Adverse Events Ejection fraction decreased- Grade 4	0 number of events	1 number of events
Incidence of Adverse Events Fatigue- Grade 3	2 number of events	0 number of events
Incidence of Adverse Events Fever- Grade 3	1 number of events	0 number of events
Incidence of Adverse Events Hypokalemia- Grade 3	0 number of events	1 number of events
Incidence of Adverse Events Lung Infection- Grade 3	0 number of events	1 number of events
Incidence of Adverse Events Lymphocyte count decreased- Grade 3	0 number of events	1 number of events
Incidence of Adverse Events Myalgia- Grade 3	1 number of events	0 number of events
Incidence of Adverse Events Neutrophil count decreased- Grade 3	31 number of events	8 number of events
Incidence of Adverse Events Neutrophil count decreased- Grade 4	11 number of events	9 number of events
Incidence of Adverse Events Platelet count decreased- Grade 3	8 number of events	1 number of events
Incidence of Adverse Events Platelet count decreased- Grade 4	3 number of events	0 number of events
Incidence of Adverse Events Sepsis- Grade 3	1 number of events	0 number of events
Incidence of Adverse Events Sinus tachycardia- Grade 3	0 number of events	1 number of events

Adverse Events

Cohort 1

Serious events: 2 serious events

Other events: 16 other events

Deaths: 10 deaths

Cohort 2

Serious events: 4 serious events

Other events: 13 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=16 participants at risk Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days	Cohort 2 n=13 participants at risk Both cohorts received 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: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days
Investigations Blood bilirubin increased	6.2% 1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.	0.00% 0/13 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.
General disorders Fever	6.2% 1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.	0.00% 0/13 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.
Infections and infestations Sepsis	6.2% 1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.	0.00% 0/13 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.
Renal and urinary disorders Acute kidney injury	0.00% 0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.	7.7% 1/13 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.
Cardiac disorders Bronchopulmonary hemorrhage	0.00% 0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.	7.7% 1/13 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.
Infections and infestations Lung infection	0.00% 0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.	7.7% 1/13 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.
Vascular disorders Thromboembolic event	0.00% 0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.	7.7% 1/13 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period. Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.

Other adverse events

Additional Information

Clinical Trials Admin

University of Michigan Rogel Cancer Center

Phone: 734-936-9499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place