Biliary Tract Carcinoma Clinical Trial
Official title:
A Randomized Phase II Trial of MEK Inhibitor Selumetinib (AZD6244) Combined Continuously or Sequentially With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Patients With Advanced Biliary Cancer
Verified date | January 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase II study (the second stage of testing a new drug or new drug combinations) to see how useful two different schedules of study drug selumetinib with cisplatin and gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer. Selumetinib, an oral drug which plays an important role in the regulation of cell growth (MEK 1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. Selumetinib has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary tract cancer. Cisplatin and gemcitabine are intravenous drugs that work by damaging DNA in tumor cells so that they are unable to grow and divide.
Status | Active, not recruiting |
Enrollment | 57 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Unresectable, recurrent or metastatic, measurable biliary tract cancer or gall bladder cancer - No prior systemic therapy - Performance status 0, 1, or 2 - Age 18 years or older - Estimated life expectancy > 3 months - Adequate hematological, liver, renal function - No evidence of active uncontrolled infection - Capable of giving written consent - Acceptable recovery of previous side effects Exclusion Criteria: - Progressing within 3 or 6 months of receiving certain treatments - Prior chemotherapy for non-resectable or metastatic disease or a MEK inhibitor - Progressing within 6 months of adjuvant treatment. - May not have received prior chemotherapy for non-resectable/metastatic disease. - Prior MEK, RAS, or RAF inhibitors or history of hypersensitivity to study drugs. - Ampullary carcinoma - Incomplete recovery from previous surgery - Undergoing treatment with curative intent - Prior malignancy that could interfere with the response evaluation - Severe or uncontrolled systemic diseases or lab finding that makes it undesirable for patient to participate - Any psychiatric or other disorder likely to impact consent - Pregnant or breastfeeding - Patients with significant cardiac-related issues - History of eye-related issues. - Systemic disease, active infection, bleeding diatheses or renal transplant, including hep B, hep C or HIV - Receiving potent inhibitors or inducers of CYP3A4/5, CYP2C19 and CYP1A2 can continue with caution |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in tumor size in millimetres | Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 10 weeks post initiation of therapy | |
Secondary | Number of participants with objective response and/or stable disease | 6 months post initiation of therapy | ||
Secondary | Percentage of patients without progressive disease | 10 weeks post initiation of therapy | ||
Secondary | Progression-free survival in months | Enrollment to disease progression or death | ||
Secondary | Overall survival in months | Time from enrollment to date of death | ||
Secondary | Total incidence of adverse events | 2 years | ||
Secondary | Total rate of grade 3 and 4 toxicities | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05009953 -
Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
|
Phase 2 | |
Recruiting |
NCT05285358 -
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
|
Phase 1 | |
Recruiting |
NCT04430738 -
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04853017 -
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT05222854 -
Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma"
|
||
Not yet recruiting |
NCT05681949 -
Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards
|
N/A | |
Terminated |
NCT01855724 -
Clinical Trial to Investigate the Efficacy of Treatment With Gemcitabine/Pazopanib in Patients With Biliary Tree Cancer
|
Phase 2 | |
Withdrawn |
NCT02105350 -
A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer
|
Phase 1 | |
Recruiting |
NCT04183712 -
Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA
|
Phase 2 | |
Active, not recruiting |
NCT02834013 -
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
|
Phase 2 | |
Completed |
NCT02649712 -
Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction
|
N/A | |
Recruiting |
NCT05194072 -
A Study of SGN-B7H4V in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT03581435 -
A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients
|
||
Completed |
NCT03201458 -
Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
|
Phase 2 | |
Completed |
NCT04740164 -
A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP
|
N/A | |
Completed |
NCT02333188 -
Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer
|
Phase 1 | |
Recruiting |
NCT05712356 -
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT00767234 -
Permission to Collect Blood Over Time for Research
|
N/A | |
Recruiting |
NCT03702491 -
Apapitatin Combined With SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
|
Phase 2 | |
Recruiting |
NCT04068194 -
Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
|
Phase 1/Phase 2 |