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Kinase Inhibitor
Vemurafenib + Sorafenib for Pancreatic Cancer
Phase 2
Recruiting
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initiation of study treatment up to study completion, up to 2 years
Awards & highlights
Study Summary
This trial will test if two oral drugs could help people with a certain type of pancreatic cancer that has gotten worse despite treatment.
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.Check my eligibility
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.See study design
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.
Select...
My pancreatic cancer has spread, is KRAS mutated, and has not responded to at least 2 treatments.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I can swallow and keep down pills.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Control Rate of Vemurafenib in Combination with Sorafenib
Secondary outcome measures
Confirm the Incidences of Adverse Events of Vemurafenib in Combination with Sorafenib
Measure circulating ctDNA
Measure phospho ERK and phospho AKT in plasma
Other outcome measures
Clinical Activity of Vemurafenib in Combination with Sorafenib
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
~3100
Find a Location
Who is running the clinical trial?
BayerIndustry Sponsor
2,238 Previous Clinical Trials
25,332,706 Total Patients Enrolled
HonorHealth Research InstituteLead Sponsor
25 Previous Clinical Trials
894 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,887 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If I enroll, am I able to take part in this clinical research?
"This clinical trial is looking for 12 participants who currently have cancer of the pancreas and are aged 18-100. In order to be eligible, potential participants must also meet the following criteria: not be a woman of childbearing potential (WOCBP) OR be a WOCBP who agrees to follow contraceptive guidance during treatment and for at least 30 days after the last dose of trial treatment; be able to understand and willing to sign a written informed consent form; have adequate organ function; have a performance status of 0 or 1 on the ECOG performance scale; demonstrate QTC ≤ 500ms."
Answered by AI
Are there any potentially fatal side effects to taking Sorafenib?
"Because Sorafenib has only been proven safe in Phase 2 clinical trials, it received a score of 2."
Answered by AI
What types of diseases does Sorafenib typically target?
"Sorafenib offers treatment to patients with non-small cell lung carcinoma, advanced renal cell carcinoma (arcc), and unresectable melanoma."
Answered by AI
How many guinea pigs are participating in this trial?
"Yes, this is an active recruitment according to the information found on clinicaltrials.gov. The trial was posted on 10/28/2021 and has not been updated since. They are looking for 12 participants at 1 site."
Answered by AI
Are elderly citizens welcome to participate in this research?
"The age range that is eligible for this clinical trial, as specified in the inclusion criteria, is 18 to 100 years old."
Answered by AI
How can interested parties get involved in this clinical trial?
"That is correct. The clinical trial in question, which can be found on the website clinicaltrials.gov, is looking for 12 participants and is currently recruiting at 1 medical centre."
Answered by AI
Is Sorafenib a common drug in clinical trials?
"At this moment, there are one hundred and eleven active clinical trials investigating sorafenib with twenty-seven of those in phase three. The majority of these studies originate from Taibei, Taiwan; however, there are 4447 locations running these tests globally."
Answered by AI
Who else is applying?
What state do they live in?
Idaho
New York
How old are they?
18 - 65
What site did they apply to?
HonorHealth Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- HonorHealth Research Institute: < 48 hours
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