Spots Global Cancer Trial Database for Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.
Official Title: A Phase 1b/2, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced Solid Tumors and Relapsed/Refractory SCLC
Study ID: NCT05271292
Interventions
Study Description
Brief 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Cancer Associates-Encintas, Encinitas, California, United States
Providence/St. Joe Cancer Institute/Crosson Cancer Institute, Fullerton, California, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Dana Farber Cancer Institue, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
OU Health, Oklahoma City, Oklahoma, United States
Sarah Cannon Research Center, Nashville, Tennessee, United States
North Houston Cancer Clinics, Huntsville, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Contact Details
Name: Cabilia Pichardo, MD
Affiliation: Executive Director of Clinical Development
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
