Your session is about to expire
← Back to Search
Defactinib + Radiotherapy for Pancreatic Cancer
Phase 2
Recruiting
Led By Hyun Kim, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance ≤ 1.5 x IULN or glomerular filtration rate of ≥ 60 mL/min
Histologically or cytologically confirmed locally advanced pancreas adenocarcinoma that is considered borderline resectable or unresectable per institutional standardized criteria of unresectability or medical inoperability (NCCN guidelines 2.2021 PANC-C 1 of 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 24 months)
Awards & highlights
Study Summary
This trial is testing whether adding the drug defactinib to standard chemotherapy and radiotherapy treatment for pancreas cancer will help patients live longer without the cancer progressing. Patients will be randomly assigned to either the experimental arm, which will receive defactinib, or the control arm, which will not. The first 6 patients in the experimental arm will be closely monitored for side effects before the trial continues with more patients. The primary outcome being measured is progression-free survival (PFS).
Who is the study for?
Adults over 18 with advanced pancreatic adenocarcinoma that's borderline resectable or unresectable, who've had at least 3 months of chemo without disease progression. Participants must have a life expectancy over 3 months, adequate organ function, and agree to use effective contraception. Excluded are those with other recent cancers, certain health conditions like uncontrolled hypertension or active infections, prior FAK inhibitor treatment, known allergies to study drugs' components, or inability to swallow pills.Check my eligibility
What is being tested?
The trial is testing if adding the drug defactinib to standard chemotherapy and stereotactic body radiotherapy (SBRT) improves survival in patients with advanced pancreas cancer compared to SBRT alone. Patients will be randomly assigned in a ratio of 6:1 to either the experimental group receiving defactinib or the control group not receiving it.See study design
What are the potential side effects?
Potential side effects include reactions related to radiation therapy such as skin changes and fatigue; defactinib may cause gastrointestinal symptoms like nausea and diarrhea, blood clots, muscle pain, eye problems and possible heart rhythm abnormalities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range.
Select...
My pancreatic cancer is advanced but cannot be surgically removed.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My bilirubin levels are normal and I don't have Gilbert's syndrome.
Select...
I am 18 years old or older.
Select...
My liver tests are within the required limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 24 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 24 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Distant metastasis progression-free survival
Local control
Objective response rate
+3 moreSide effects data
From 2014 Phase 1 trial • 9 Patients • NCT0194329267%
Blood Bilirubin Increased
33%
Decreased Appetite
33%
Cancer Pain
33%
Diarrhea
33%
Pain in Extremity
33%
Abdominal Distension
33%
Nasopharyngitis
33%
Blood Creatinine Increased
33%
Blood Pressure Increased
33%
Cough
33%
Pain of Skin
33%
Fatigue
33%
Headache
33%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Defactinib 400 mg Bid
Defactinib 200 mg Bid
Defactinib 600 mg Bid
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MR-guided SBRT + DefactinibExperimental Treatment4 Interventions
Participants in this study will receive 5 fractions of magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) and seventeen 21-day cycles of defactinib (beginning on Day 2 of radiation).
Participants who are candidates for surgical resection will undergo standard of care surgery at 2 weeks post-end of SBRT (+/- 1 weeks) or 12 weeks post-end of SBRT (+/- 1 week). These participants will discontinue defactinib the day prior to the operation and will resume taking it for the remainder of the 17 cycles 4 to 6 weeks after surgery. Participants who are not candidates for surgical resection will continue to receive defactinib uninterrupted. All participants should receive 17 cycles of defactinib unless they experience disease progression or intolerable toxicity.
Group II: MR-guided SBRTActive Control2 Interventions
-Participants in this study will receive 5 fractions of magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tumor biopsy
2014
Completed Phase 2
~240
Research blood draw
2022
Completed Phase 2
~240
Defactinib
2013
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,812 Total Patients Enrolled
Verastem, Inc.Industry Sponsor
38 Previous Clinical Trials
2,556 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,936 Previous Clinical Trials
2,299,648 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids or have it now.My bone marrow and organs are functioning normally.Your corrected QT interval is less than 480 milliseconds.My blood clotting time is normal or managed with medication.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have not had major surgery in the last 28 days.I've completed 3 months of chemotherapy for my condition without the disease getting worse.My kidney function is within the required range.You have a history of hepatitis B or currently have hepatitis C.You have previously developed antibodies against human antibodies.My cancer has spread to nearby lymph nodes only, as confirmed by a radiation oncologist.My pancreatic cancer is advanced but cannot be surgically removed.You have enough infection-fighting white blood cells in your body.I have an immune system disorder or am on long-term steroids or other drugs that weaken my immune system.I am fully active and can carry on all pre-disease activities without restriction.You are expected to live for more than 3 months.I haven't taken any P-gp affecting drugs in the last 14 days.Your hemoglobin level must be at least 9.0 grams per deciliter.I have an active tuberculosis infection.My blood clotting time is within a safe range, even if I'm on blood thinners.I must keep taking warfarin and cannot switch to another blood thinner.My bilirubin levels are normal and I don't have Gilbert's syndrome.Your albumin level is at least 2.5 mg/dL.Your platelet count is at least 100,000 per microliter.You have had allergic reactions to drugs similar to defactinib.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I had cancer before, but I finished treatment over 2 years ago and am now cancer-free.I need procedures to remove excess fluid from my abdomen or chest.I do not have any uncontrolled illnesses like infections or high blood pressure.I have not been treated with specific immune system targeting drugs before.I have HIV but my CD4+ T-cell count is above 350 and I haven't had an AIDS-related infection in the last year.I cannot take pills by mouth or have issues absorbing them due to stomach surgery or active bowel inflammation.You have had a bad reaction to the non-active ingredients in the study drug.You have been diagnosed with COVID-19 in the last 28 days before starting the study treatment.My liver tests are within the required limits.
Research Study Groups:
This trial has the following groups:- Group 1: MR-guided SBRT + Defactinib
- Group 2: MR-guided SBRT
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.
Are there still vacancies available for participation in this experiment?
"Affirmative. The details on clinicaltrials.gov demonstrate that this research project, which was first published in July 2021, is actively recruiting participants. 42 volunteers need to be enrolled from a single medical centre."
Answered by AI
Are there prior experiments involving Defactinib that have been conducted?
"Currently, 9 distinct clinical trials are underway for Defactinib with none in the advanced Phase 3 of testing. San Diego, California is home to most of these investigations but there are 1557 different medical sites conducting research on this drug."
Answered by AI
To what extent does Defactinib guarantee patient safety?
"The safety of Defactinib was assessed as a 2, given that while prior data supports its security profile, there is yet to be any evidence confirming efficacy."
Answered by AI
How many individuals have been included in the participant pool of this clinical trial?
"That is correct. The details found on clinicaltrials.gov indicate that patient recruitment for this medical trial commenced July 21st 2021 and was recently updated November 16th 2022. Forty-two individuals need to be enrolled from one specific healthcare facility."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger