A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer
Summary
To evaluate the safety, tolerability and preliminary evidence for efficacy of KA2507 (an orally active potent and selective HDAC6 inhibitor) in patients with advanced biliary tract cancer (BTC) previously treated with standard of care chemotherapy.
The specific aims of each part of the study are:
Part A : Phase Ib primary objective - to determine the recommended phase II dose (RP2D) of KA2507 for part B and evaluate its tolerability profile in advanced BTC.
Part B: Phase II primary objective - to assess the efficacy of KA2507 in patients with advanced BTC at the dose defined in part A.
Description
To evaluate the safety, tolerability and preliminary evidence for efficacy of KA2507 (an orally active potent and selective HDAC6 inhibitor) in patients with advanced biliary tract cancer (BTC) previously treated with standard of care chemotherapy.
The specific aims of each part of the study are:
Part A : Phase Ib primary objective - to determine the recommended phase II dose (RP2D) of KA2507 for part B and evaluate its tolerability profile in advanced BTC.
Part B: Phase II primary objective - to assess the efficacy of KA2507 in patients with advanced BTC at the dose defined in part A.
ABC-11 is an open-label, multi-centre study of HDAC6 inhibition using KA2507 in patients with advanced biliary tract cancer previously treated with standard of care chemotherapy.
Part A design (phase Ib safety - dose finding)
This is a phase Ib dose finding study to determine the recommended Phase II dose (RP2D) for Part B.
Dose escalation of KA2507 in Part A will be based on a combination of treatment-related dose limiting toxicities (DLTs) at the end of cycle 1 and (plasma) KA2507 pharmacokinetics. This dose finding study will be conducted using the modified continual reassessment method (CRM)1-3, a model-based design that informs how the dosage of KA2507 should be adapted for the next patient cohort based on past trial data. The RP2D will be defined as the highest dose that has an estimated probability of a DLT closest to a target toxicity level of 30%. Patients will be dosed in cohorts of 2, with a maximum available sample size of 8 evaluable patients.
Part B design (phase II efficacy)
This is a single-arm single-stage phase II study designed using A'Hern's methodology.
Patients for part B are comprised of two groups: 1) the patients from Part A treated at the dose to be tested in Part B; and 2) an additional expansion cohort of patients registered to part B. A fixed daily dose of KA2507 will be administered to all patients based on the RP2D determined in Part A (anticipated to be one of either 800 mg bid, 1200 mg bid or 1600 mg daily bid).
Study Design
Conditions
Biliary Tract Cancer
Intervention
KA2507
Status
Not yet recruiting
Source
Karus Therapeutics Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04186156
- ClinicalTrials.gov processed this data on December 09, 2019
Published on BioPortfolio: 2019-12-10T01:20:59-0500
Clinical Trials
A Study of OSI-7904L Versus 5-FU/LV as Treatment in Patients With Biliary Tract Cancer
Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.
This research is studying the effect of the combination of how two study drugs (Nivolumab and DKN-01) works in people with advanced biliary tract cancer.
EXIBIT: Oxaliplatin in Biliary Tract Cancer
The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST un...
The Role of ctDNA and PBMC in Treatment of Biliary Tract Cancer
Our study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of biliary tract cancer.
Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing
The purpose of this study is to investigate genetic mutations affecting prognosis using whole genome sequencing in patients with biliary tract cancer.
PubMed Articles
In biliary tract cancer (BTC), standard chemotherapy has limited benefit and no molecular targeted agents have been approved. This study investigated the genetic profile of BTC to identify potential n...
Laparoscopic left lateral sectionectomy (LLS) followed by a biliary tract exploration is used to treat left lateral hepatolithiasis. The purpose of this study was to compare the efficacy of two method...
Exome sequencing of 22 genes using tissue from patients with biliary tract cancer.
Biliary tract cancers (BTC) are a rare heterogeneous disease group with a dismal prognosis and limited treatment options. The mutational landscape consists of genetic aberrations both shared by and ch...
Self-expandable metal stents (SEMS) are a widely accepted biliary endoprosthesis for patients with unresectable malignant biliary obstruction. Here, we identified predictors for the occlusion of SEMS ...
Chemotherapy is the mainstay of systemic treatment of biliary tract cancer (BTC). However, the treatment response to chemotherapy varies between patients. Currently, no prognostic biomarkers for chemo...
Medical and Biotech [MESH] Definitions
Biliary Tract Neoplasms
Tumors or cancer in the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.
Biliary Fistula
Abnormal passage in any organ of the biliary tract or between biliary organs and other organs.
Biliary Tract Diseases
Diseases in any part of the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.
Cholangitis, Sclerosing
Chronic inflammatory disease of the BILIARY TRACT. It is characterized by fibrosis and hardening of the intrahepatic and extrahepatic biliary ductal systems leading to bile duct strictures, CHOLESTASIS, and eventual BILIARY CIRRHOSIS.
Biliary Tract Surgical Procedures
Any surgical procedure performed on the biliary tract.
More From BioPortfolio on "A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer"
Quick Links
Advanced Search |
Login |
Subscribe |
RSS 
BioPortfolio Twitter Channels (200+ Accounts)
LinkedIn