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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 below

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My solid tumor cannot be surgically removed, has no other treatment options, or I refuse standard treatments.

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I can take care of myself and am up and about more than half of the day.

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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:

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There is a known treatment that could cure or extend my life.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months after completion of study treatment for reporting.

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 • NCT01664897

48%

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

Tumor Lysis Syndrome

Thromboembolic Event

Pleuritic Pain

Skin Infection

Oral Mucositis

Pain

Seizure

Blood and Lymphatic System disorder - other

Espohageal Ulcer

Hematoma

Hyperbilirubinemia

Hypotension

100%

80%

60%

40%

20%

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