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Protein Kinase Inhibitor
Vismodegib + Erlotinib (+/- Gemcitabine) for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Charles Erlichman
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic proof of a solid tumor that is now unresectable, not amenable to any other standard therapies, or patient refuses standard therapy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Must not have
Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after completion of study treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying the side effects and best dose of a cancer drug when given with another cancer drug, with or without another drug.
Who is the study for?
This trial is for adults with metastatic pancreatic cancer or solid tumors that can't be surgically removed. They must not have curative standard therapy options, agree to use effective contraception, abstain from smoking, and be able to take oral medication. Excluded are those who've had certain recent treatments, uncontrolled illnesses, CNS metastases unless stable, pregnant/nursing women, or inadequate organ function.
What is being tested?
The study tests the side effects and optimal doses of erlotinib hydrochloride combined with GDC-0449 (vismodegib), with or without gemcitabine hydrochloride in patients. These drugs aim to stop tumor growth by killing cells or preventing cell division and blocking enzymes needed for cell growth.
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the drugs which may affect organs; fatigue; digestive issues like nausea and diarrhea; blood-related problems such as anemia; skin rash due to enzyme inhibition; and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My solid tumor cannot be surgically removed, has no other treatment options, or I refuse standard treatments.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
I can swallow pills or receive them through a G-tube.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
There is a known treatment that could cure or extend my life.
Select...
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Select...
Criterion: You cannot have received certain types of treatments within specific time frames before the study. You also cannot have certain medical conditions or be taking certain medications. Additionally, if you are pregnant, nursing, or not using reliable birth control, you cannot participate. If you have certain heart conditions, eye abnormalities, or have had specific prior treatments, you may not be eligible to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months after completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after completion of study treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose of erlotinib hydrochloride defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients
Secondary study objectives
Adverse events as assessed by NCI CTCAE v3.0
Response as assessed by modified RECIST criteria
Side effects data
From 2018 Phase 2 trial • 29 Patients • NCT0166489748%
Pneumonia
45%
Neutropenic Fever
38%
Shortness of breath
34%
Fatigue
34%
Diarrhea
31%
Lung Infection
28%
Nausea
24%
Rash
17%
Edema
17%
Muscle Aches
17%
Watery eyes
14%
Dizziness
10%
Sepsis
10%
Death
10%
Fever
3%
Tumor Lysis Syndrome
3%
Thromboembolic Event
3%
Pleuritic Pain
3%
Skin Infection
3%
Oral Mucositis
3%
Pain
3%
Seizure
3%
Blood and Lymphatic System disorder - other
3%
Espohageal Ulcer
3%
Hematoma
3%
Hyperbilirubinemia
3%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Erlotinib Hydrochloride)
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: Treatment (vismodegib, erlotinib hydrochloride, gemcitabine)Experimental Treatment4 Interventions
Patients receive Hedgehog antagonist GDC-0449 PO QD and erlotinib hydrochloride PO QD on days 1-28. Some patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vismodegib
2015
Completed Phase 4
~1880
Erlotinib Hydrochloride
2010
Completed Phase 2
~2900
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,886 Previous Clinical Trials
41,020,904 Total Patients Enrolled
Charles ErlichmanPrincipal InvestigatorMayo Clinic
5 Previous Clinical Trials
243 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a certain amount of a type of white blood cell called neutrophils in your blood.My solid tumor cannot be surgically removed, has no other treatment options, or I refuse standard treatments.My pancreatic cancer has spread and can be biopsied.I can take care of myself and am up and about more than half of the day.You are expected to live for at least 12 weeks.You need to have a negative pregnancy test within the last 7 days before joining the study.Your AST levels are not more than three times the upper limit of normal.Your creatinine level is not more than 1.5 times the upper limit of normal.Your hemoglobin level is at least 9.0 grams per deciliter.Your blood clotting level is normal.There is a known treatment that could cure or extend my life.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I can swallow pills or receive them through a G-tube.I agree to use effective birth control and not smoke.You must have at least 100,000 platelets per microliter of blood.Your bilirubin level is within the normal range.Criterion: You cannot have received certain types of treatments within specific time frames before the study. You also cannot have certain medical conditions or be taking certain medications. Additionally, if you are pregnant, nursing, or not using reliable birth control, you cannot participate. If you have certain heart conditions, eye abnormalities, or have had specific prior treatments, you may not be eligible to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (vismodegib, erlotinib hydrochloride, gemcitabine)
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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