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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.