Biliary Tract CarcinomaPhase 1NCT02105350
A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer
A Phase 1 study testing MEK 162, Gemcitabine and Oxaliplatin in people with Biliary Tract Carcinoma and Gallbladder Carcinoma, run by University Health Network, Toronto.
Trial summary
This is a phase I study (an early study to check the safety of a new drug or drug combination) to find the safest and most tolerated dose of the combination of oxaliplatin with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers and cancers associated with the bile ducts leading from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Carcinoma, Gallbladder Carcinoma
- What is being tested?
- MEK 162, Gemcitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological or cytological diagnosis of non-resectable, recurrent or metastatic biliary tract (intra- or extra-hepatic) or gallbladder carcinoma.
- Have measurable disease.
- Not received prior systemic therapy for advanced biliary cancer.
- Age 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Estimated life expectancy is greater than 3 months.
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- Have adequate hematological function.
- Have adequate cardiac function.
- All radiology studies performed within 4 weeks prior to the start of therapy.
- No evidence of active uncontrolled infection.
- Ability to understand and willing to sign a written informed consent document.
- Ongoing prior toxicities related to previous treatments received to grade 1 or less at time of registration.
- Able to take oral medications.
Who cannot join
- Progressing within 6 months of receiving adjuvant treatment for biliary tract cancer.
- Not have received prior chemotherapy for non-resectable or metastatic disease or MEK inhibitor.
- Histopathological or cytological diagnosis of ampullary carcinoma.
- Incomplete recovery from previous surgery.
- Undergoing current treatment with curative intent.
- History of prior malignancy that could interfere with the response evaluation.
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- Any evidence of severe or uncontrolled systemic diseases or laboratory findings that may affect participation in the trial.
- Any psychiatric or other disorder likely to impact on informed consent.
- Pregnant or nursing (lactating) women.
- Agree to use highly effective methods of contraception throughout the study and for 6 months after study drug discontinuation.
- Significant cardiac disease.
- History of retinal degenerative disease.
- History of Gilbert's syndrome.
- Known positive serology for HIV, active hepatitis B, and/or active hepatitis C infection.
- Neuromuscular disorders that are associated with elevated creatine kinase.
- Planning on embarking on a new strenuous exercise regimen after first dose of study treatment.
- Impairment of gastrointestinal function or gastrointestinal disease.
- Any other condition that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.
About this study
Official title: A Phase I Trial of MEK Inhibitor MEK 162 Combined Sequentially With Gemcitabine-Oxaliplatin (GEMOX) in Patients With Advanced Biliary Cancer
This is a phase I study (an early study to check the safety of a new drug or drug combination) to find the safest and most tolerated dose of the combination of oxaliplatin with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers and cancers associated with the bile ducts leading from the gallbladder and to and from the liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where cancer started). Everyone will receive the same standard doses of oxaliplatin and gemcitabine but may receive different doses of MEK 162.
MEK 162 is a new drug which plays an important role in the regulation of cell growth and has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. This type of drug 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 cancer.
- Conditions
- Biliary Tract Carcinoma, Gallbladder Carcinoma
- Being tested
- MEK 162, Gemcitabine, Oxaliplatin
- Keywords
- MEK162, Gemcitabine, Oxaliplatin, Non-resectable, Recurrent or metastatic
- Medical subject headings
- Gallbladder Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEK 162Drug
GemcitabineDrug
Also called Gemzar
OxaliplatinDrug
Also called Eloxatin
| Study group | Role | What they receive |
|---|---|---|
| MEK 162, gemcitabine, and oxaliplatin | Experimental | MEK 162 (30 mg or 45 mg by mouth), twice a day, every day. Gemcitabine (1000 mg/m2 by vein), followed by oxaliplatin (85 mg/m2 by vein) every 2 weeks. Receives: Drug: MEK 162; Drug: Gemcitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total incidence of grade 3 and 4 adverse events
Measured: 2 years
Total rate of grade 3 and 4 adverse events
Measured: 2 years
Maximum dose level at which 0/3 patients or 1/6 patients experience dose-limiting toxicity
Measured: 2 years
Secondary outcomes (1)
Number of patients with objective response rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Study was never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Knox, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105350
- Sponsor's protocol ID
- Biliary GEMOX / MEK
- Status last verified
- Feb 2018
- First submitted
- 2 Apr 2014
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of MEK Inhibitor MEK 162 Combined Sequentially With Gemcitabine-Oxaliplatin (GEMOX) in Patients With Advanced Biliary Cancer
- ClinicalTrials.gov ID
- NCT02105350
- Acronym / sponsor ID
- Biliary GEMOX / MEK
- Conditions
- Biliary Tract Carcinoma, Gallbladder Carcinoma
- Keywords
- MEK162, Gemcitabine, Oxaliplatin, Non-resectable, Recurrent or metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I study (an early study to check the safety of a new drug or drug combination) to find the safest and most tolerated dose of the combination of oxaliplatin with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers and cancers associated with the bile ducts leading from the gallbladder and to and from the liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where cancer started). Everyone will receive the same standard doses of oxaliplatin and gemcitabine but may receive different doses of MEK 162.
MEK 162 is a new drug which plays an important role in the regulation of cell growth and has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. This type of drug 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 cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEK 162, gemcitabine, and oxaliplatin | Experimental | Drug: MEK 162, Drug: Gemcitabine, Drug: OxaliplatinMEK 162 (30 mg or 45 mg by mouth), twice a day, every day. Gemcitabine (1000 mg/m2 by vein), followed by oxaliplatin (85 mg/m2 by vein) every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histopathological or cytological diagnosis of non-resectable, recurrent or metastatic biliary tract (intra- or extra-hepatic) or gallbladder carcinoma.
- Have measurable disease.
- Not received prior systemic therapy for advanced biliary cancer.
- Age 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Key exclusion criteria (18 listed)
- Progressing within 6 months of receiving adjuvant treatment for biliary tract cancer.
- Not have received prior chemotherapy for non-resectable or metastatic disease or MEK inhibitor.
- Histopathological or cytological diagnosis of ampullary carcinoma.
- Incomplete recovery from previous surgery.
- Undergoing current treatment with curative intent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEK 162 | Drug | MEK 162, gemcitabine, and oxaliplatin |
| GemcitabineAlso: Gemzar | Drug | MEK 162, gemcitabine, and oxaliplatin |
| OxaliplatinAlso: Eloxatin | Drug | MEK 162, gemcitabine, and oxaliplatin |
Primary outcome
Total incidence of grade 3 and 4 adverse events
Time frame: 2 years
Total rate of grade 3 and 4 adverse events
Time frame: 2 years
Maximum dose level at which 0/3 patients or 1/6 patients experience dose-limiting toxicity
Time frame: 2 years
1 secondary outcome
Number of patients with objective response rate
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Knox, M.D. principal investigator
Princess Margaret Cancer Centre
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEK 162, Gemcitabine and Oxaliplatin in people with Biliary Tract Carcinoma and Gallbladder Carcinoma, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total incidence of grade 3 and 4 adverse events (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.