Trial · NCT04076579

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

NCT04076579, Phase 2, Completed, University of Michigan Rogel Cancer Center; results first posted 2024-07-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma. Trials, record NCT04076579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04076579

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
NCT number: NCT04076579
Status: Completed
Phases: Phase 2
Enrollment: 29 participants, actual
Lead sponsor: University of Michigan Rogel Cancer Center
Conditions: Sarcoma, Sarcoma Metastatic
Interventions: Olaparib, Trabectedin
First posted: 2019-09-03
Last updated: 2025-08-29
Results first posted: 2024-07-29

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate	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.
Secondary	Progression Free Survival	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.
Secondary	Progression Free Survival	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
Secondary	Overall Survival	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.
Secondary	Incidence of Adverse Events	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate	Up to 2 years	one patient in cohort 2 was not evaluable	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival	At 6 months		months	MEDIAN
SECONDARY	Progression Free Survival	At 1 year after enrollment		percentage of patients	NUMBER
SECONDARY	Overall Survival	At 2 years after enrollment		probability estimates	NUMBER
SECONDARY	Incidence of Adverse Events	Up to 30 days after end of treatment, and average of 4.5 months		number of events	NUMBER

Source ClinicalTrials.gov

Results by group52

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Response Rate	Cohort 1		0		Participants
Overall Response Rate	Cohort 2		2		Participants
Progression Free Survival	Cohort 1		4.1	95% Confidence Interval 3.3 to NA	months
Progression Free Survival	Cohort 2		3.8	95% Confidence Interval 2.2 to NA	months
Progression Free Survival	Cohort 1		8.9		percentage of patients
Progression Free Survival	Cohort 2		20.2		percentage of patients
Overall Survival	Cohort 1	1 year post enrollment	0.52	95% Confidence Interval 0.28 to 0.94	probability estimates
Overall Survival	Cohort 2	1 year post enrollment	0.48	95% Confidence Interval 0.24 to 0.94	probability estimates
Overall Survival	Cohort 1	2 year post enrollment	0	95% Confidence Interval 0 to 0	probability estimates
Overall Survival	Cohort 2	2 year post enrollment	0.12	95% Confidence Interval 0.02 to 0.74	probability estimates

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1	16
Overall Study	STARTED	Cohort 2	13
Overall Study	COMPLETED	Cohort 1	12
Overall Study	COMPLETED	Cohort 2	9
Overall Study	NOT COMPLETED	Cohort 1	4
Overall Study	NOT COMPLETED	Cohort 2	4

Source ClinicalTrials.gov

Adverse events128

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	General disorders	Cohort 1	3	16	3
other	Abdominal pain	General disorders	Cohort 2	1	13	1
other	Alanine aminotransferase increased	Investigations	Cohort 1	7	16	13
other	Alanine aminotransferase increased	Investigations	Cohort 2	4	13	7
other	Alkaline phosphatase increased	Investigations	Cohort 1	1	16	1
other	Alkaline phosphatase increased	Investigations	Cohort 2	2	13	3
other	Allergic reaction	General disorders	Cohort 1	1	16	1
other	Allergic reaction	General disorders	Cohort 2	0	13	0
other	Anemia	Investigations	Cohort 1	11	16	28
other	Anemia	Investigations	Cohort 2	6	13	15

1 to 10 of 128Source ClinicalTrials.gov

See all 128 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1	10	16
Total, all-cause mortality	Cohort 2	5	13
Total, other adverse events	Cohort 1	16	16
Total, other adverse events	Cohort 2	13	13
Total, serious adverse events	Cohort 1	2	16
Total, serious adverse events	Cohort 2	4	13

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Cohort 1 vs Cohort 2: Overall Response Rate	Trial comparisons
Cohort 1 vs Cohort 2: deaths from any cause	Trial comparisons
Cohort 1 vs Cohort 2: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04076579

GET https://conductscience.org/api/trials/v1/NCT04076579/results?page=2

API reference For AI assistants