## Protocol Section
### Identification Module
**NCT ID:** NCT04076579

**Brief Title:** Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

**Official Title:** Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

#### Organization Study ID Info
**ID:** UMCC 2018.132
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan Rogel Cancer Center
#### Secondary ID Infos
**Domain:** University of Michigan
**ID:** HUM00161251
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Last Update Post Date
**Date:** 2023-08-31

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-30

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-01-30

**Type:** ACTUAL

#### Start Date
**Date:** 2020-03-17

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2019-09-03
**Type:** ACTUAL
**Study First Submit Date:** 2019-08-29
**Study First Submit QC Date:** 2019-08-29
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Janssen Scientific Affairs, LLC

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan Rogel Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief 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 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 Module

**Conditions:**

- Sarcoma

- Sarcoma Metastatic

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 29

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: Olaparib

- Drug: Trabectedin

**Label:** Olaparib + Trabectedin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Olaparib + Trabectedin

**Description:** Olaparib taken by mouth twice daily

**Name:** Olaparib

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Olaparib + Trabectedin

**Description:** Trabectedin administered intravenously (IV) every 21 days

**Name:** Trabectedin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Overall response rate

**Time Frame:** Up to 2 years

#### Secondary Outcomes

**Description:** 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.

**Measure:** Progression free survival

**Time Frame:** At 6 months

**Description:** 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.

**Measure:** Progression free survival

**Time Frame:** At approximately 2 years after enrollment

**Description:** Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median, 1- and 2-year OS will be estimated along with their 95% confidence intervals.

**Measure:** Overall survival

**Time Frame:** At approximately 2 years after enrollment

**Description:** 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.

**Measure:** Incidence of adverse events

**Time Frame:** Up to 30 days after end of treatment

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria

* 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
* 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

Key Exclusion Criteria

* 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

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan Rogel Cancer Center

**State:** Michigan

**Zip:** 48109

#### Overall Officials

**Official 1:**

**Affiliation:** University of Michigan Rogel Cancer Center

**Name:** Rashmi Chugh, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15327

- Name: Sarcoma

- Relevance: HIGH

- As Found: Sarcoma

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T5284

- Name: Soft Tissue Sarcoma

- Relevance: HIGH

- As Found: Sarcoma

### Condition Browse Module - Meshes

- ID: D000012509

- Term: Sarcoma

### Intervention Browse Module - Ancestors

- ID: D000067856

- Term: Poly(ADP-ribose) Polymerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000018906

- Term: Antineoplastic Agents, Alkylating

- ID: D000000477

- Term: Alkylating Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M233003

- Name: Olaparib

- Relevance: HIGH

- As Found: Fentanyl

- ID: M1862

- Name: Trabectedin

- Relevance: HIGH

- As Found: Excluded

- ID: M205

- Name: Poly(ADP-ribose) Polymerase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20942

- Name: Antineoplastic Agents, Alkylating

- Relevance: LOW

- As Found: Unknown

- ID: M3820

- Name: Alkylating Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000531550

- Term: Olaparib

- ID: D000077606

- Term: Trabectedin

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2024-03-18

##### Submission Infos

- MCP Release N: 10

- Release Date: 2024-03-18

- Reset Date: 2024-04-12

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- MCP Release N: 11

- Release Date: 2024-05-06

- Reset Date: 2024-05-15

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
