Ignite Creation Date:
2024-05-06 @ 3:47 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02375880
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2015-02-18
Brief Title:
Study of DKN-01 and GemcitabineCisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder
Sponsor:
Leap Therapeutics Inc
Organization:
Leap Therapeutics Inc
Study Overview
Official Title:
A Dose Escalation and Cohort Expansion Study of DKN-01 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Carcinoma Primary to the Intra- or Extra-hepatic Biliary System or Gallbladder
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
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:
DKN-01 is a humanized monoclonal antibody Mab with neutralizing activity against Dkk-1 and is being developed as an anti-neoplastic agent This study is designed to evaluate the safety tolerability pharmacokinetics and anti-tumor activity of DKN-01 in combination with gemcitabine and cisplatin in patients with carcinoma primary to the intra- or exta-hepatic biliary system or gallbladder
Detailed Description:
In Part A escalating doses of DKN-01 will be administered to different cohorts of patients to evaluate safety and dose limiting toxicities DLTs and to establish the maximum tolerated dose of DKN-01 when administered in combination with gemcitabine and cisplatin
Part B is an expansion cohort in which patients are treated at the MTD of DKN-01 or highest dose tested if the MTD is not defined to further characterize safety tolerability pharmacokinetics and efficacy within the defined patient population
Part B is an expansion cohort in which patients are treated at the MTD of DKN-01 or highest dose tested if the MTD is not defined to further characterize safety tolerability pharmacokinetics and efficacy within the defined patient population
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