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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00161251 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib + Trabectedin | Experimental | There are 2 cohorts. Both cohorts receive the same treatment:
Treatment consists of 21-day cycles for a maximum of 18 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | Olaparib taken by mouth twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months |
| Progression Free Survival |
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Key Inclusion Criteria
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Rashmi Chugh, M.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Both cohorts receive the same treatment:
|
| FG001 | Cohort 2 | Both cohorts receive the same treatment:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Both cohorts received the same treatment:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | one patient in cohort 2 was not evaluable | Posted | Count of Participants | Participants | Up to 2 years |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Both cohorts received the same treatment:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | ClinicalTrialsgov_CCAdmin@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2022 | Mar 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2024 | Mar 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C531550 | olaparib |
| D000077606 | Trabectedin |
| ID | Term |
|---|---|
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| Trabectedin |
| Drug |
Trabectedin administered intravenously (IV) every 21 days |
|
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 |
| 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. | 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. | Up to 30 days after end of treatment, and average of 4.5 months |
| Physician Decision |
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| Patient was deemed ineligible before starting study treatment |
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| Noncompliance |
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| Withdrawal by Subject |
|
| BG001 |
| Cohort 2 |
Both cohorts received the same treatment:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Both cohorts received the same treatment:
|
|
| Secondary | 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. | Posted | Median | 95% Confidence Interval | months | At 6 months |
|
|
|
| Secondary | 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 | Posted | Number | percentage of patients | At 1 year after enrollment |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | probability estimates | At 2 years after enrollment |
|
|
|
| Secondary | 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. | Posted | Number | number of events | Up to 30 days after end of treatment, and average of 4.5 months |
|
|
|
| 10 |
| 16 |
| 2 |
| 16 |
| 16 |
| 16 |
| EG001 | Cohort 2 | Both cohorts received the same treatment:
| 5 | 13 | 4 | 13 | 13 | 13 |
| Fever | General disorders | Non-systematic Assessment |
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| Sepsis | Infections and infestations | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
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| Bronchopulmonary hemorrhage | Cardiac disorders | Non-systematic Assessment |
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| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
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| Alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| Allergic reaction | General disorders | Non-systematic Assessment |
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| Anemia | Investigations | Non-systematic Assessment |
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| Anorexia | Psychiatric disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
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| Back pain | General disorders | Non-systematic Assessment |
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| Blood bilirubin increased | Hepatobiliary disorders | Non-systematic Assessment |
|
| Bruising | General disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Creatinine increased | Investigations | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dysgeusia | General disorders | Non-systematic Assessment |
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| Dyspepsia | General disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Ejection fraction decreased | Investigations | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Hemorrhoids | General disorders | Non-systematic Assessment |
|
| Hiccups | General disorders | Non-systematic Assessment |
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| Hypocalcemia | Investigations | Non-systematic Assessment |
|
| Hypokalemia | Investigations | Non-systematic Assessment |
|
| Mucositis oral | General disorders | Non-systematic Assessment |
|
| Myalgia | General disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
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| Platelet count decreased | Investigations | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
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| Sore throat | General disorders | Non-systematic Assessment |
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| Thrush | General disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Weight loss | General disorders | Non-systematic Assessment |
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| White blood cell decreased | Investigations | Non-systematic Assessment |
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| Edema limbs | General disorders | Non-systematic Assessment |
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| Epistaxis | Vascular disorders | Non-systematic Assessment |
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| Hyperglycemia | Investigations | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Hypoalbuminemia | Investigations | Non-systematic Assessment |
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| Hyponatremia | Investigations | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
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| Memory impairment | General disorders | Non-systematic Assessment |
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| Nasal congestion | General disorders | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Paresthesia | Nervous system disorders | Non-systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
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| D007546 |
| Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Anemia- Grade 3 |
|
| Aspartate aminotransferase increased - Grade 3 |
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| Blood bilirubin increased- Grade 3 |
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| Bronchopulmonary hemorrhage - Grade 3 |
|
| Ejection fraction decreased- Grade 4 |
|
| Fatigue- Grade 3 |
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| Fever- Grade 3 |
|
| Hypokalemia- Grade 3 |
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| Lung Infection- Grade 3 |
|
| Lymphocyte count decreased- Grade 3 |
|
| Myalgia- Grade 3 |
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| Neutrophil count decreased- Grade 3 |
|
| Neutrophil count decreased- Grade 4 |
|
| Platelet count decreased- Grade 3 |
|
| Platelet count decreased- Grade 4 |
|
| Sepsis- Grade 3 |
|
| Sinus tachycardia- Grade 3 |
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| White blood cell decreased- Grade 3 |
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| White blood cell decreased- Grade 4 |
|