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Kinase Inhibitor
Vemurafenib + Sorafenib for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Erkut Borazanci, MD, MS
Research Sponsored by HonorHealth Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be ≥ 18 years of age on day of signing informed consent.
Histologically confirmed cancer of the pancreas (KRAS mutated) with metastases and progression on at least ≥ 2 prior treatment regimens for their disease.
Must not have
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1/Day 1 or who has not recovered (i.e. NCI-CTC AE Version 5.0 ≤ Grade 1 at the time of signing informed consent) from adverse events due to a previously administered agent(s).
Patient with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v5.0 ≥ Grade 2 within 4 weeks before initiating study treatment; any other hemorrhage/bleeding event of NCI-CTCAE v5.0 ≥ Grade 3 within 4 weeks before initiating study treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initiation of study treatment up to study completion, up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two types of cancer-fighting pills, Vemurafenib and Sorafenib, in patients with a specific type of pancreatic cancer. These patients have not improved with standard treatments. The pills work by blocking signals that help the cancer cells grow. Sorafenib is an oral multiple kinase inhibitor that has been approved for the treatment of advanced liver and kidney cancers.
Who is the study for?
This trial is for adults over 18 with KRAS mutated pancreatic cancer that has spread and worsened after at least two prior treatments. Participants must be able to take oral meds, have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have no major health issues that could interfere with the study.
What is being tested?
The trial tests Vemurafenib and Sorafenib's effectiveness in treating advanced pancreatic cancer with a specific mutation. These are oral chemotherapy drugs given to those who haven't responded well to standard treatments.
What are the potential side effects?
Potential side effects of Vemurafenib and Sorafenib may include fatigue, skin reactions, digestive problems, liver issues, high blood pressure, bleeding risks, heart rhythm changes (QT prolongation), and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My pancreatic cancer has spread, is KRAS mutated, and has not responded to at least 2 treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can swallow and keep down pills.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had cancer treatment in the last 2 weeks and have recovered from past treatment side effects.
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I have not had serious lung bleeding or any severe bleeding in the last month.
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I am not allergic to sorafenib, vemurafenib, or any related drugs.
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I am currently being treated for an infection.
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I have a history of bleeding or clotting disorders.
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I have seizures that are not controlled by medication.
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I have been diagnosed with Neurofibromatosis Type 1 or a similar condition.
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I have previously used a BRAF inhibitor like vemurafenib.
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I haven't taken any medications that affect heart rhythm recently.
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I haven't taken strong medication that affects liver enzymes in the last 28 days.
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I am able to follow the study's requirements and attend all follow-up visits.
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I have a wound, ulcer, or bone fracture that is not healing.
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I do not have any serious heart conditions.
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I have had an organ transplant.
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I have had pneumonitis treated with steroids or have it now.
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I have had significant surgery on my stomach or intestines.
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My high blood pressure is not controlled even with medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initiation of study treatment up to study completion, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initiation of study treatment up to study completion, up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease Control Rate of Vemurafenib in Combination with Sorafenib
Secondary study objectives
Confirm the Incidences of Adverse Events of Vemurafenib in Combination with Sorafenib
Measure circulating ctDNA
Measure phospho ERK and phospho AKT in plasma
Other study objectives
Clinical Activity of Vemurafenib in Combination with Sorafenib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Vemurafenib in Combination with SorafenibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib
2014
Completed Phase 3
~1670
Vemurafenib
2015
Completed Phase 3
~3550
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer, such as Vemurafenib and Sorafenib, work by targeting specific molecular pathways involved in cancer cell growth and survival. Vemurafenib inhibits the BRAF protein, which is part of the MAPK/ERK signaling pathway often mutated in cancers, thereby reducing uncontrolled cell proliferation.
Sorafenib, a multi-kinase inhibitor, targets several kinases involved in tumor growth and blood vessel formation, including RAF kinases, VEGFR, and PDGFR. These targeted therapies are significant for pancreatic cancer patients as they offer a more precise approach to treatment, potentially improving outcomes and reducing side effects compared to conventional chemotherapy.
MiR-338-5p Inhibits EGF-Induced EMT in Pancreatic Cancer Cells by Targeting EGFR/ERK Signaling.Current and future strategies for combined-modality therapy in pancreatic cancer.
MiR-338-5p Inhibits EGF-Induced EMT in Pancreatic Cancer Cells by Targeting EGFR/ERK Signaling.Current and future strategies for combined-modality therapy in pancreatic cancer.
Find a Location
Who is running the clinical trial?
BayerIndustry Sponsor
2,270 Previous Clinical Trials
25,508,720 Total Patients Enrolled
HonorHealth Research InstituteLead Sponsor
25 Previous Clinical Trials
894 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,555 Previous Clinical Trials
569,288 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment in the last 2 weeks and have recovered from past treatment side effects.I have not had serious lung bleeding or any severe bleeding in the last month.I know my cancer's KRAS and BRAF mutation status or have a sample for testing.I have stable brain metastases and haven't used steroids in the last 7 days.I am not allergic to sorafenib, vemurafenib, or any related drugs.My organs are functioning well.I am 18 years old or older.I am currently being treated for an infection.I have a history of bleeding or clotting disorders.I haven't had a stroke or blood clot in the last 6 months.I have seizures that are not controlled by medication.I have been diagnosed with Neurofibromatosis Type 1 or a similar condition.I have previously used a BRAF inhibitor like vemurafenib.I haven't taken any medications that affect heart rhythm recently.I haven't taken strong medication that affects liver enzymes in the last 28 days.I am able to follow the study's requirements and attend all follow-up visits.My pancreatic cancer has spread, is KRAS mutated, and has not responded to at least 2 treatments.I am fully active or restricted in physically strenuous activity but can do light work.I am a woman who can have children and have had a negative pregnancy test within the last 24 hours.I am not pregnant or breastfeeding and either cannot become pregnant or will follow the contraceptive guidelines if I can.You have a disease that can be measured using a specific set of guidelines.I agree to use birth control and not donate sperm during and for 30 days after treatment.Your heart's QTC should be less than 500 milliseconds.I can swallow and keep down pills.I have a wound, ulcer, or bone fracture that is not healing.I do not have any serious heart conditions.I have had cancer before, but it was not pancreatic, and I've been cancer-free for over 3 years.I have had an organ transplant.I have had pneumonitis treated with steroids or have it now.I have had significant surgery on my stomach or intestines.I am still recovering from major surgery complications.My high blood pressure is not controlled even with medication.
Research Study Groups:
This trial has the following groups:- Group 1: Vemurafenib in Combination with Sorafenib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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