Study design and patient selection
bleeding, squamous cell non-small cell lung cancer, ICH, Tumors, gastrointestinal perforation, fistula, hematologic, hepatic, and renal function
UNCONTROLLED HYPERTENSION, BLEEDING, THROMBOEMBOLIC EVENT, CARDIOVASCULAR DISEASE, SOLID TUMORS, TUMORS, GASTROINTESTINAL PERFORATION, ONCOLOGY
This was an open-label, phase 1/1b study of fruquintinib that enrolled U.S. patients with advanced solid tumors of any type (except squamous cell non-small cell lung cancer) conducted at 9 study centers in the U.S. In the dose escalation phase, eligible patients were adults ≥ 18 years old with histologically or cytologically confirmed, locally advanced or metastatic solid tumors who had progressed on approved systemic therapy and for which no effective treatment or standard of care was available. Additional key inclusion criteria included body weight ≥ 40 kg; at least 1 measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; and adequate hematologic, hepatic, and renal function. Key exclusion criteria included prior use of a VEGF inhibitor; systemic antineoplastic therapy or any investigational therapy within 4 weeks or 5 half-lives (whichever was shorter) of the first dose of study drug; uncontrolled hypertension; history of recent bleeding; history of gastrointestinal perforation or fistula; active cardiovascular disease; or recent thromboembolic events.This study was conducted in accordance with the protocol, the ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals of Human Use (ICH) Good Clinical Practice (GCP) and other guidelines, and applicable laws and regulations. Informed consent was obtained before the patient was entered into the study.