Pancreatic CancerPhase 2NCT02428270
A Study of GSK2256098 and Trametinib in Advanced Pancreatic Cancer
A Phase 2 study testing GSK2256098 and Trametinib in people with Pancreatic Cancer and Adenocarcinoma, run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
This is a phase 2 study (the second phase in testing a new drug or combination to see how effect the drug or combination is) of investigational drugs GSK2256098 and Trametinib. The purpose of the study is to evaluate the antitumor activity of GSK2256098 and Trametinib in patients with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Adenocarcinoma
- What is being tested?
- GSK2256098 and Trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesCanada
- Study dates
- Apr 2016to 27 Oct 2022
- Phase
- Phase 2
- 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
- Male or female, 18 years or older, able to give written consent
- Pancreatic adenocarcinoma that is not responsive to standard therapies or for which there is no approved or curative therapy or for patients who refuse standard therapy
- Have clinical, radiographic, or serologic progression after one prior line of chemotherapy for advanced disease. Patients who have received two or more prior lines of chemotherapy for advanced disease are not eligible.
- Performance Status score of 0 or 1
- Measureable disease by RECIST version 1.1
- Able to swallow and retain oral medication
Show all 10Show fewer
- Have malignant disease that is amenable to biopsy and agree to collection of mandatory tumor biopsy samples.
- Agrees to use contraception
- Not pregnant
- Adequate organ system function
Who cannot join
- Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapy including investigational drugs within 28 days or 5 half lives. No prior MEK inhibitor, RAF inhibitors or a FAK inhibitors
- Current use of a prohibited medication
- Unresolved toxicity greater than Grade 1 from previous anticancer therapy unless the ongoing toxicity will not introduce additional risk factors and will not interfere with the study procedures.
- Presence of active GI disease or other condition that could affect gastrointestinal absorption or predisposed to GI ulceration
- Evidence of mucosal or internal bleeding
- Anticoagulation with warfarin
Show all 24Show fewer
- Major surgery within the last four weeks
- Malignancies related to HIV or HBV/HCV
- Known active infection requiring parenteral or oral anti-infective treatment
- Leptomeningeal disease.
- Brain metastases
- QTcF interval ≥ 480 msecs
- History or evidence of current clinically significant uncontrolled arrhythmias
- History of acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting within six months of screening.
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Other clinically significant ECG abnormalities
- Intra-cardiac defibrillators.
- Presence of cardiac metastases.
- Serious or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety or providing informed consent.
- Known immediate or delayed hypersensitivity to any of the components of the study treatment(s).
- Evidence of severe or uncontrolled systemic diseases
- Pregnant or lactating
- History of retinal vein occlusion
- History of interstitial lung disease or pneumonitis
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Juravinski Cancer Center
Hamilton, Ontario, L8V 5C2
London Regional Cancer Centre
London, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies: A Phase II Trial of GSK2256098 and Trametinib in Patients With Advanced Pancreatic Cancer
This is a phase 2 study (the second phase in testing a new drug or combination to see how effect the drug or combination is) of investigational drugs GSK2256098 and Trametinib.
The purpose of the study is to evaluate the antitumor activity of GSK2256098 and Trametinib in patients with advanced pancreatic cancer.
Read the detailed description
Trametinib is a drug that works by binding to and blocking certain proteins called mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working. MEK1 and MEK2 are important proteins that contribute to the growth of cancer cells.
GSK2256098 is a drug that blocks a protein called focal adhesion kinase-1 (FAK) which is an important protein that contribute to the growth of cancer cells.
- Conditions
- Pancreatic Cancer, Adenocarcinoma
- Being tested
- GSK2256098, Trametinib
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2256098Drug
Small molecule inhibitor of focal adhesion kinase (FAK)
TrametinibDrug
Also called Mekinist
Allosteric inhibitor of mitogen-activated extracellular signal-regulated kinase (MEK)1 and MEK2 activation and kinase activity.
| Study group | Role | What they receive |
|---|---|---|
| GSK2256098 and Trametinib | Experimental | GSK2256098, orally, at 0.375 or 0.5 mg, once daily, continuously every 28 day cycles.
Trametinib, orally at 250 mg or 500 mg, twice daily, continuously every 28 day cycles. Receives: Drug: GSK2256098; Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who experience complete response, partial response, or stable disease
Measured: 24 weeks
Secondary outcomes (4)
Adverse events based on frequency and proportion of total patients, by system organ class and preferred term.
Measured: 2 years
Percentage of patients achieving either a complete or partial tumor response.
Measured: 2 years
Interval between the date of randomization and the earliest date of disease progression or death due to any cause
Measured: 2 years
Interval between the first date of CR or PR and the earliest date of disease progression or death due to any cause.
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 posted28 Apr 2015 (estimated)
- Study startApr 2016
- Primary completionJun 2017
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Philippe Bedard, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428270
- Sponsor's protocol ID
- MOBILITY-002
- Status last verified
- Oct 2022
- First submitted
- 23 Apr 2015
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies: A Phase II Trial of GSK2256098 and Trametinib in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02428270
- Acronym / sponsor ID
- MOBILITY-002
- Conditions
- Pancreatic Cancer, Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 28 Apr 2015 (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 2 study (the second phase in testing a new drug or combination to see how effect the drug or combination is) of investigational drugs GSK2256098 and Trametinib.
The purpose of the study is to evaluate the antitumor activity of GSK2256098 and Trametinib in patients with advanced pancreatic cancer.
Detailed description
Trametinib is a drug that works by binding to and blocking certain proteins called mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working. MEK1 and MEK2 are important proteins that contribute to the growth of cancer cells.
GSK2256098 is a drug that blocks a protein called focal adhesion kinase-1 (FAK) which is an important protein that contribute to the growth of cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK2256098 and Trametinib | Experimental | Drug: GSK2256098, Drug: TrametinibGSK2256098, orally, at 0.375 or 0.5 mg, once daily, continuously every 28 day cycles. Trametinib, orally at 250 mg or 500 mg, twice daily, continuously every 28 day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, 18 years or older, able to give written consent
- Pancreatic adenocarcinoma that is not responsive to standard therapies or for which there is no approved or curative therapy or for patients who refuse standard therapy
- Have clinical, radiographic, or serologic progression after one prior line of chemotherapy for advanced disease. Patients who have received two or more prior lines of chemotherapy for advanced disease are not eligible.
- Performance Status score of 0 or 1
- Measureable disease by RECIST version 1.1
Key exclusion criteria (24 listed)
- Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapy including investigational drugs within 28 days or 5 half lives. No prior MEK inhibitor, RAF inhibitors or a FAK inhibitors
- Current use of a prohibited medication
- Unresolved toxicity greater than Grade 1 from previous anticancer therapy unless the ongoing toxicity will not introduce additional risk factors and will not interfere with the study procedures.
- Presence of active GI disease or other condition that could affect gastrointestinal absorption or predisposed to GI ulceration
- Evidence of mucosal or internal bleeding
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 |
|---|---|---|
| GSK2256098Small molecule inhibitor of focal adhesion kinase (FAK) | Drug | GSK2256098 and Trametinib |
| TrametinibAlso: MekinistAllosteric inhibitor of mitogen-activated extracellular signal-regulated kinase (MEK)1 and MEK2 activation and kinase activity. | Drug | GSK2256098 and Trametinib |
Primary outcome
Percentage of patients who experience complete response, partial response, or stable disease
Time frame: 24 weeks
4 secondary outcomes
Adverse events based on frequency and proportion of total patients, by system organ class and preferred term.
Time frame: 2 years
Percentage of patients achieving either a complete or partial tumor response.
Time frame: 2 years
Interval between the date of randomization and the earliest date of disease progression or death due to any cause
Time frame: 2 years
Interval between the first date of CR or PR and the earliest date of disease progression or death due to any cause.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Philippe Bedard, M.D. principal investigator
Princess Margaret Cancer Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK2256098 and Trametinib in people with Pancreatic Cancer and Adenocarcinoma, run by University Health Network, Toronto at 4 sites in Canada.
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 10 inclusion and 24 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: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients who experience complete response, partial response, or stable disease (time frame: 24 weeks). 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 1 Nov 2022.