Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
Not provided
The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy.
The main question it aims to answer is:
• What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma?
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab govitecan-hziy | Drug | 10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Objective response is defined a confirmed overall response of complete response (CR) or partial response (PR) as assessed by RECIST v1.1. The objective response rate (ORR) will be estimated number of evaluable patients with a documented objective response divided by the total number of evaluable patients. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | DOR will be evaluated in evaluable patients who had a documented objective response. This is the time from the documented objective response, as assessed by RECIST v1.1, until disease progression or death, whichever occurs first. Patients who are alive without a documented disease progression will be censored at the time of their last disease evaluation. | 1 year |
Not provided
Inclusion Criteria:
Age >/= 18 years at time of signing informed consent form (ICF)
Ability to understand and the willingness to sign a written informed consent document
Patients with histologically confirmed advanced thymoma or thymic carcinoma
Patients who have experienced disease progression after treatment with at least one prior systemic therapy
Measurable disease per RECIST v1.1
Availability of pre-treatment tumor tissue (archival or fresh); If archival tissue is not available and a fresh biopsy is not considered safe and medically feasible by the Investigator, the patient may be approved for enrollment after consultation with the Principal Investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (1500/uL) without filgrastim support
Platelet count >/= 100 x 10^9/L (100,000/uL) without transfusion
Hemoglobin (Hgb) >/= 80 g/L (8 g/dL). Patients may be transfused to meet this criterion.
Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) </= 2.5 x upper limit of normal (ULN), with the following exceptions:
Creatinine clearance >/= 30 mL/min (calculated using the Cockcroft-Gault formula, see Appendix 2)
For patients not receiving therapeutic anticoagulation: INR and aPTT </= 1.5 x ULN
Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chul Kim, MD | Contact | 202-444-2223 | Chul.Kim@gunet.georgetown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chul Kim, MD | Chul.Kim@gunet.georgetown.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Recruiting | Palo Alto | California | 94304 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time from the time of treatment initiation until disease progression or death, whichever occurs first. Patients who are alive without a documented progression will be censored at the time of their last disease evaluation | 1 year |
| Overall survival (OS) | Overall survival (OS) is defined as the time of treatment initiation until death. Patients who are alive will be censored at the time of their last contact. | 1 year |
| Lombardi Comprehensive Cancer Center, Georgetown University | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
|
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
|
| John Theurer Cancer Center at Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |