Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02374489
Status:
TERMINATED
Last Update Posted:
2018-04-05
First Post:
2015-02-23
Brief Title:
A Phase II Trial of LDK378 in ROS1 and or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
A Phase II Trial of LDK378 as the First or Second-line Therapy in ROS1 and or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
ROS1 in IHC and gene rearrangement result can not matchNo tumor response
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective
To investigate the objective response rate in patients with ROS1 or ALK over-expressed locally advanced or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378 Secondary objectivesThe progression-free survival The disease control rate The overall survival The toxicity profiles The correlation between clinical outcomes and the potential predictive biomarker for tumor response
To investigate the objective response rate in patients with ROS1 or ALK over-expressed locally advanced or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378 Secondary objectivesThe progression-free survival The disease control rate The overall survival The toxicity profiles The correlation between clinical outcomes and the potential predictive biomarker for tumor response
Detailed Description:
Sample size LDK378 will be considered as an active agent and deserved for further development Considering 10 dropout rate total 34 patients will be included
Step 1 LDK378 in suitable patients
Collect tumor tissue for immunohistochemistry staining to confirm the status of ROS1 or ALK expression If the patient fits all criteria LDK378 750 mg po daily with 3 week as a treatment cycle
Step 2 Evaluation of tumor response according to RECIST 11 version
1 Evaluation will be done at baseline and every 6 weeks
2 Evaluation will be performed with CT or MRI and the response is defined as follows
Complete response - the disappearance of all target lesions
Partial response - at least a 30 decrease in the sum of the longest diameter of target lesions compared to the baseline sum longest diameter
Progressive disease - at least a 20 increase in the sum of the longest diameter of target lesions compared to the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or reappearance of any lesion that had disappeared or clear worsening of any assessable disease or appearance of any new lesion or site
Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease compared to the smallest sum longest diameter since the treatment started
Step 1 LDK378 in suitable patients
Collect tumor tissue for immunohistochemistry staining to confirm the status of ROS1 or ALK expression If the patient fits all criteria LDK378 750 mg po daily with 3 week as a treatment cycle
Step 2 Evaluation of tumor response according to RECIST 11 version
1 Evaluation will be done at baseline and every 6 weeks
2 Evaluation will be performed with CT or MRI and the response is defined as follows
Complete response - the disappearance of all target lesions
Partial response - at least a 30 decrease in the sum of the longest diameter of target lesions compared to the baseline sum longest diameter
Progressive disease - at least a 20 increase in the sum of the longest diameter of target lesions compared to the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or reappearance of any lesion that had disappeared or clear worsening of any assessable disease or appearance of any new lesion or site
Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease compared to the smallest sum longest diameter since the treatment started
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None