BridgeMD
New treatment option for Gastrointestinal Cancer
Official title Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy
ClinicalTrials.gov ID: NCT06065371
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for gastrointestinal cancer.
Also referred to as Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Female or male patients, 18 years of age or older, able to understand and give written informed consent
- Patients with the histologically or cytologically documented metastatic adenocarcinoma of gastrointestinal origin, including gastroesophageal...
- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute...
- Adequate hepatic function (bilirubin ≤ 1.5x upper limit normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5xULN...
- Adequate renal function (Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation.
You likely can't join if
- Positive serum pregnancy test or women who are breastfeeding.
- Known hypersensitivity to the study drug(s), its metabolites, or formulation excipient.
- Requirement for ongoing therapy with or prior use of any prohibited medications listed in protocol.
- Have had a prior anticancer biologic agent within 4 weeks prior to enrolment or have had prior chemotherapy, targeted small molecule therapy, or...
- Have previously received topoisomerase 1 inhibitors.
- Have an active second malignancy. Note: patients with a history of malignancy that have been completely treated, with no evidence of active cancer...
See the full eligibility criteria
- Female or male patients, 18 years of age or older, able to understand and give written informed consent
- Patients with the histologically or cytologically documented metastatic adenocarcinoma of gastrointestinal origin, including gastroesophageal, colorectal, and pancreaticobiliary that have failed standard therapy
- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1500/mm3, and platelets ≥ 100,000/μL).
- Adequate hepatic function (bilirubin ≤ 1.5x upper limit normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5xULN or ≤ 5xULN if known liver metastases, and serum albumin \> 3 g/dL).
- Adequate renal function (Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation.
- Male and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. Females of childbearing potential must not have had unprotected...
- Male people who are partners of women of childbearing potential must use a condom and spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods...
- Willing and able to comply with the requirements and restrictions in this protocol
- Positive serum pregnancy test or women who are breastfeeding.
- Known hypersensitivity to the study drug(s), its metabolites, or formulation excipient.
- Requirement for ongoing therapy with or prior use of any prohibited medications listed in protocol.
- Have had a prior anticancer biologic agent within 4 weeks prior to enrolment or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not...
- Have previously received topoisomerase 1 inhibitors.
- Have an active second malignancy. Note: patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrolment, or patients with surgically cured tumors...
- Have unstable brain metastases. Note: Patients with stable brain metastasis can be included. "Stable" brain metastases may be defined as: Prior local treatment by radiation, surgery, or stereotactic surgery, imaging -...
- Met any of the following criteria for cardiac disease:
- Myocardial infarction or unstable angina pectoris within 6 months of enrolment.
- History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for...
- New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of \< 40%.
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrolment.
- Have active serious infection requiring antibiotics.
- Have known history of HIV-1 or 2 (or positive HIV-1/2 antibody, if done at screening) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
- Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for...
- Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive...
- Patients who test positive for HIV antibody.
- Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow- up examinations.
- Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study [list examples as necessary].
- Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.