Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03873532
Status:
UNKNOWN
Last Update Posted:
2020-02-13
First Post:
2019-03-12
Brief Title:
A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients
Sponsor:
Hutchison Medipharma Limited
Organization:
Hutchmed
Study Overview
Official Title:
A Randomized Open Multi-center Phase IIbIII Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Capecitabine in Advanced or Metastatic Biliary Tract Carcinoma BTC Patients
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized open-label active-control multi-center phase IIbIII clinical study to evaluate the efficacy and safety of surufatinib vs Capecitabine as a second-line therapy in patients with unresectable or metastatic biliary tract cancer BTC About 298 subjects are randomly assigned to two study treatment groups in the ratio of 11 by Interactive Web Response System IWRS
Active group 300 mg of surufatinibonce a day for 3 weeks as a cycle
Control group In each 3-week cycle Capecitabine is given at 1250 mgm2 by oral administration twice a day for 2 weeks followed by 1 week rest period equivalent to 2500 mgm2 total daily dose
All patients will be treated based on the arm to which they have been randomized Treatment on study will continue until disease progression death intolerable toxicity or other criteria for discontinuation from study treatment The tumor assessments are performed with imaging every 6 weeks 3 days until progressive disease RECIST v11 or death on the study treatment period and the treatment and survival of the patients after progressive disease are recorded Safety indicators include adverse events laboratory tests vital signs and changes in electrocardiograms and echocardiograms
Active group 300 mg of surufatinibonce a day for 3 weeks as a cycle
Control group In each 3-week cycle Capecitabine is given at 1250 mgm2 by oral administration twice a day for 2 weeks followed by 1 week rest period equivalent to 2500 mgm2 total daily dose
All patients will be treated based on the arm to which they have been randomized Treatment on study will continue until disease progression death intolerable toxicity or other criteria for discontinuation from study treatment The tumor assessments are performed with imaging every 6 weeks 3 days until progressive disease RECIST v11 or death on the study treatment period and the treatment and survival of the patients after progressive disease are recorded Safety indicators include adverse events laboratory tests vital signs and changes in electrocardiograms and echocardiograms
Detailed Description:
This is a randomized open-label active-control multi-center phase IIbIII clinical study to evaluate the efficacy and safety of surufatinib vs Capecitabine as a second-line therapy in patients with unresectable or metastatic biliary tract cancer BTC About 298 subjects are randomly assigned to two study treatment groups in the ratio of 11 by IWRS
Active group 300 mg of surufatinib is given by oral administration once a day QD every 3 weeks
Control group In each 3-week cycle Capecitabine is given at 1250 mgm2 by oral administration twice a day BID for 2 weeks followed by 1 week rest period equivalent to 2500 mgm2 total daily dose
Patients are randomized with the following stratification factors
Eastern Cooperative Oncology Group ECOG Performance Status 0 or 1
Years from the first diagnosis of BTC to the randomization date 1 year or 1 year
The primary site of the tumor intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma or gallbladder cancer
All patients will be treated based on the arm to which they have been randomized Treatment on study will continue until disease progression death intolerable toxicity or other criteria for discontinuation from study treatment The tumor assessments are performed with imaging every 6 weeks 3 days until progressive disease RECIST v11 or death on the study treatment period and the treatment and survival of the patients after progressive disease are recorded Safety indicators include adverse events laboratory tests vital signs and changes in electrocardiograms and echocardiograms
Active group 300 mg of surufatinib is given by oral administration once a day QD every 3 weeks
Control group In each 3-week cycle Capecitabine is given at 1250 mgm2 by oral administration twice a day BID for 2 weeks followed by 1 week rest period equivalent to 2500 mgm2 total daily dose
Patients are randomized with the following stratification factors
Eastern Cooperative Oncology Group ECOG Performance Status 0 or 1
Years from the first diagnosis of BTC to the randomization date 1 year or 1 year
The primary site of the tumor intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma or gallbladder cancer
All patients will be treated based on the arm to which they have been randomized Treatment on study will continue until disease progression death intolerable toxicity or other criteria for discontinuation from study treatment The tumor assessments are performed with imaging every 6 weeks 3 days until progressive disease RECIST v11 or death on the study treatment period and the treatment and survival of the patients after progressive disease are recorded Safety indicators include adverse events laboratory tests vital signs and changes in electrocardiograms and echocardiograms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None