Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy (NCT04868773) | Clinical Trial Compass
CompletedPhase 1
Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy
United States15 participantsStarted 2021-07-16
Plain-language summary
This is a phase I clinical trial assessing the safety and recommended phase II dose of cabozantinib in combination with trifluridine/tipiracil (TAS102) in patients with metastatic colorectal carcinoma (mCRC).
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. leukocytes ≥ 3,000/mcL
✓. absolute neutrophil count ≥ 1,500/mcL
✓. platelets ≥ 100,000/mcl
✓. total bilirubin within normal institutional limits
✓. AST(SGOT)/ALT(SPGT) ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present
✓. creatinine \<1.5 ULN
✓. hemoglobin ≥ 8 g/dL
✓. Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg
Exclusion criteria
✕. ongoing or active infection
✕. Cardiovascular disorders: Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias; uncontrolled hypertension defined as sustained blood pressure (BP) \> 140 mm Hg systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment; Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #3.2.8) for at least 1 week before first dose of study treatment.
✕. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.
What they're measuring
1
Dose Limiting Toxicity [DLT]
Timeframe: From the start date of treatment until 4 weeks after the last patient has started treatment, an average of 1 year.
2
Recommended Phase 2 Dose [RP2D]
Timeframe: From the start date of treatment until 4 weeks after the last patient has started treatment, an average of 1 year.
✕. Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.
✕. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
✕. Lesions invading any major blood vessels. Subjects with lesions invading the intrahepatic vasculature, including portal vein, hepatic vein, and hepatic artery, are eligible.
✕. Other clinically significant disorders that would preclude safe study participation:
✕. Active infection requiring systemic treatment (based on investigator assessment). Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection.