Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.
18 Years and older, Male and Female
CAR107 (primary)
NCI-2022-09477
Summary
This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages:
Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods)
Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled
in this phase once daily for 28-day cycles continuously with no interruption between cycles.
Objectives
Phase 1b:
Patients with advanced solid malignant tumor (including SCLC, NSCLC, colorectal carcinoma,
pancreatic carcinoma, hepatocellular carcinoma, ovarian cancer, neuroendocrine tumors,
non-Hodgkin's lymphoma and others) that has relapsed from or is refractory to standard
therapy or for which no standard therapy exists will be enrolled to the 35 mg, 50 mg and 65
mg dose cohorts in this stage. The starting dose is 35 mg, and each higher dose cohort will
not enroll until the lower dose is deemed safe.
After screening, eligible patients will be enrolled sequentially in 3 dose-escalating
cohorts. Based on an estimated average body weight of 60 kg, the initial dose of chiauranib
will be 35 mg once daily, and the dose will be escalated to 50 mg and 65 mg once daily,
depending on the occurrence and frequency of DLTs. The 3+3 design will be employed in dose
escalation decisions.
Each dose cohort will enroll at least 3 patients. Overenrolling dosing cohorts is allowed to
allow for potential screen failures and/or subjects who end up being not evaluable by not
completing the DLT evaluation period. Each subject will undergo both a single-dose period (6
days) and a consecutive-dose (1 cycle of 28 days) period, as described below. DLTs will be
evaluated during this period (a total of 34 days).
Phase 2:
SCLC patients with progressive disease or recurrence after at least 2 previous regimens,
including one platinum-based chemotherapy, will be enrolled in this stage. The RP2D will be
given to all subjects enrolled in this stage. Subjects will take the RP2D chiauranib once
daily for 28-day cycles continuously with no interruption between cycles.
Eligibility
- Patient is at least 18 years of age, regardless of gender. Patient has a diagnosis of histologically or cytologically confirmed advanced solid malignant tumor (including SCLC, NSCLC, colorectal carcinoma, pancreatic carcinoma, hepatocellular carcinoma, ovarian cancer, neuroendocrine tumors, non-Hodgkin's lymphoma, and others) that has relapsed from or is refractory to standard therapy or for which no standard therapy exists.
- Patient has at least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease progression, after treatment with radiotherapy or local-regional therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at enrollment.
- Major organ functions meet the following criteria (no corrective treatment, such as G CSF, erythropoietin, and blood transfusion, within 2 weeks before enrollment):
- Hematology: absolute neutrophil count (ANC) =1.5×109/L, platelet =100×109/L, hemoglobin =100 g/L.
- Biochemistry: total bilirubin =1.25×upper limit of normal (ULN), both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =1.5×ULN (=5×ULN for patients with hepatic metastasis), creatinine clearance >60 mL/min (according to Cockcroft-Gault equation), fasting triglyceride =3.0 mmol/L, fasting total cholesterol =7.75 mmol/L.
- Coagulation panel: international normalized ratio (INR) <1.5.
- Patient has a life expectancy =3 months.
- Patient is able to provide voluntary informed consent.
- Women of childbearing potential (WOCBP) must be willing and able to take highly effective contraceptive measures during the entire study treatment period and for 12 weeks after the last dose of study drug (see Appendix 11.7). Women of childbearing potential include premenopausal and not sterilized (by hysterectomy, bilateral ligation of fallopian tubes, or bilateral oophorectomy) females who have passed menarche.
- Male patients must be willing and able to use male condoms and their female partners who are WOCBP during the entire study treatment and for the 12 weeks after the last dose of the study drug.
Treatment Sites in Georgia
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