Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06065371
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-09-13
Brief Title:
Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I study to evaluate the safety and tolerability of sacituzumab govitecan in combination with capecitabine for advanced gastrointestinal cancers after progression on standard therapy and to assess correlation of outcomes with the biomarker Trop-2
Detailed Description:
This is a single institution open-label phase I trial that aims to assess the safety of combination sacituzumab govitecan plus capecitabine in the treatment of patients with gastrointestinal cancers after progression on standard therapy Gastrointestinal cancers eligible include pancreaticobiliary cancers colorectal cancers and upper gastrointestinal cancers such as esophageal gastroesophageal junction and gastric cancers The trial follows a 3 3 design and has three planned dose levels The starting dose of sacituzumab govitecan is 75mgkg intravenously on Days 1 and 8 The starting dose of capecitabine is 500mgm2 orally twice daily for two weeks on and one week off Plan is accrue a total of 20 patients
The primary endpoint is the recommended phase 2 dose RP2D Secondary Endpoints include adverse events objective response rate ORR duration of response DoR progression-free survival PFS and overall survival OS There is an exploratory endpoint of the correlation between Trop-2 expression and clinical outcomes
Patients will be recruited from the Gastrointestinal GI Medical Oncology clinics within the Henry Ford Cancer Institute HFCI campuses The study is divided into a Screening period Treatment period End of Treatment EOT period and Follow-up period
During Screening period patients will provide written informed consent ICF to participate in the study before completing any protocol-specified procedures or evaluations not considered to be part of the patients standard care Procedures that were performed for standard of care prior to signing informed consent may be used for screening purposes eg full physical exam as long as the procedures were completed within the 28-day screening period After signing the ICF patients will be evaluated for entry criteria during the screening period within 28 days before administration of study drugs Rescreening after screen failure will be allowed
Treatment will continue until unacceptable toxicity death progression of disease PD per RECIST 11 Investigators decision to discontinue treatment the patient withdraws consent is lost to follow-up or Institution decides to terminate the trial Patients with PD per RECIST 11 but with otherwise stable or improved performance and clinical status may continue to be treated in the event of a perceived benefit per Investigator see Section Treatment beyond progression Patients with a partial response PR or stable disease SD will continue to receive treatment until achievement of a confirmed complete response CR disease progression or intolerance to therapy It is at the discretion of the Investigator to continue treating patients with a confirmed CR
The primary endpoint is the recommended phase 2 dose RP2D Secondary Endpoints include adverse events objective response rate ORR duration of response DoR progression-free survival PFS and overall survival OS There is an exploratory endpoint of the correlation between Trop-2 expression and clinical outcomes
Patients will be recruited from the Gastrointestinal GI Medical Oncology clinics within the Henry Ford Cancer Institute HFCI campuses The study is divided into a Screening period Treatment period End of Treatment EOT period and Follow-up period
During Screening period patients will provide written informed consent ICF to participate in the study before completing any protocol-specified procedures or evaluations not considered to be part of the patients standard care Procedures that were performed for standard of care prior to signing informed consent may be used for screening purposes eg full physical exam as long as the procedures were completed within the 28-day screening period After signing the ICF patients will be evaluated for entry criteria during the screening period within 28 days before administration of study drugs Rescreening after screen failure will be allowed
Treatment will continue until unacceptable toxicity death progression of disease PD per RECIST 11 Investigators decision to discontinue treatment the patient withdraws consent is lost to follow-up or Institution decides to terminate the trial Patients with PD per RECIST 11 but with otherwise stable or improved performance and clinical status may continue to be treated in the event of a perceived benefit per Investigator see Section Treatment beyond progression Patients with a partial response PR or stable disease SD will continue to receive treatment until achievement of a confirmed complete response CR disease progression or intolerance to therapy It is at the discretion of the Investigator to continue treating patients with a confirmed CR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None