Sitravatinib
DrugAdministered orally as a capsule
Other names: MGCD516
NCT Number: NCT03941873
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of sitravatinib as monotherapy and in combination with tislelizumab in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) or gastric/gastroesophageal junction (G/GEJ) cancer.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
This was an open-label, multicenter Phase 1/2 clinical study for participants with histologically or cytologically confirmed unresectable locally advanced or metastatic HCC or G/GEJ cancer. All participants received study treatment (s) until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered orally as a capsule
Other names: MGCD516
Administered intravenously
Other names: BGB-A317, Tevimbra
Time frame: Up to approximately 4 years and 1 month
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), including relevant physical examination, electrocardiograms, and laboratory assessments. Safety analysis set is presented by dose, as prespecified in the statistical analysis plan (SAP).
Time frame: Up to approximately 4 years and 1 month
ORR is defined as the percentage of participants whose best overall response (BOR) is the confirmed complete response (CR) or partial response (PR) assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.
Time frame: Up to approximately 4 years and 1 month
DOR is defined as the time from the first determination of an objective response until the first documentation of progressive disease as assessed by investigator per RECIST v1.1, or death, whichever comes first. Results are reported for indication groups with responders, defined as complete response (CR) or partial response (PR). Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.
Time frame: Up to approximately 4 years and 1 month
DCR is defined as the percentage of participants with BOR as CR, PR, or stable disease (SD) assessed by investigator per RECIST v1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.
Time frame: Up to approximately 4 years and 1 month
PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first. Safety analysis set is presented by indication group, as prespecified in the statistical analysis plan.
Time frame: Predose and up to 24 hours postdose on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 21 (C1D21) (21 days in each cycle)
Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Time frame: Predose and 6 hours postdose in Cycle 5 Day 1 (21 days in each cycle)
BeiGene
Industry
A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib as Monotherapy and in Combination With Tislelizumab in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04962958
Adenocarcinoma, Antimetabolites
Guangzhou, Guangdong, China
View Trial DetailsNCT05461430
Adenocarcinoma, Adenoma
Oakland, California, United States
View Trial DetailsNCT05848947
Adenocarcinoma, Carcinoma
Spokane, Washington, United States
View Trial DetailsNCT04008082
Adenocarcinoma, Carcinoma
Osaka, Japan
View Trial Details