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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)

Must not have

Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 24 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My kidney function is within the required range.

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My pancreatic cancer is advanced but cannot be surgically removed.

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I am fully active and can carry on all pre-disease activities without restriction.

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My bilirubin levels are normal and I don't have Gilbert's syndrome.

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I am 18 years old or older.

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My liver tests are within the required limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pneumonitis treated with steroids or have it now.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I have not had major surgery in the last 28 days.

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I have an immune system disorder or am on long-term steroids or other drugs that weaken my immune system.

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I haven't taken any P-gp affecting drugs in the last 14 days.

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I have an active tuberculosis infection.

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I must keep taking warfarin and cannot switch to another blood thinner.

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I have not received a live vaccine in the last 30 days.

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I need procedures to remove excess fluid from my abdomen or chest.

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I do not have any uncontrolled illnesses like infections or high blood pressure.

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I have not been treated with specific immune system targeting drugs before.

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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.

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I cannot take pills by mouth or have issues absorbing them due to stomach surgery or active bowel inflammation.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) (Experimental Arm only)

Secondary study objectives

Distant metastasis progression-free survival (DM-PFS) (Experimental Arm only)

Local control (Experimental Arm only)

Number of participants with acute adverse events (Experimental Arm only)

+3 more

Side effects data

From 2014 Phase 1 trial • 9 Patients • NCT01943292

67%

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%

Study treatment Arm

Defactinib 400 mg Bid

Defactinib 200 mg Bid

Defactinib 600 mg Bid

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adaptive SBRT + DefactinibExperimental Treatment4 Interventions

* Participants in this study will receive 5 fractions of magnetic resonance adaptive 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: Adaptive SBRTActive Control2 Interventions

-Participants in this study will receive 5 fractions of magnetic resonance adaptive stereotactic body radiation therapy (SBRT)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tumor biopsy

2014

Completed Phase 2

~280

Research blood draw

2022