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Adult Solid NeoplasmPhase 1NCT00878163

GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery

A Phase 1 study testing Diagnostic Laboratory Biomarker Analysis, Erlotinib Hydrochloride and Gemcitabine Hydrochloride in people with Adult Solid Neoplasm and Pancreatic Acinar Cell Carcinoma, run by National Cancer Institute (NCI) at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Diagnostic Laboratory Biomarker Analysis, Erlotinib Hydrochloride and Gemcitabine Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
4 sitesUnited States
Study dates
31 Mar 2009to 6 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic proof of a solid tumor that is now unresectable, not amenable to any other standard therapies, or patient refuses standard therapy
  • Metastatic adenocarcinoma of the pancreas amenable to biopsies (cohort II MTD only)
  • Absolute neutrophil count (ANC) >= 1,500/μL
  • Platelets >= 100,000/μL
  • Total bilirubin =< upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) =< 3 times upper limit of normal (ULN)
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  • Creatinine =< 1.5 times ULN
  • Hemoglobin >= 9.0 g/dL
  • International Normalized Ratio (INR) within normal limits (for patients treated at the MTD)
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic for follow up
  • Life expectancy >= 12 weeks
  • Willingness to provide the biologic specimens as required by the protocol
  • Negative serum pregnancy test done =< 7 days prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • Able to swallow or have medication administered through a G-tube and absorb the medication
  • Participant agrees to use an acceptable form of contraception; acceptable forms of contraception:
  • Latex condom (always used with spermicide)
  • Diaphragm (always used with spermicide)
  • Cervical cap (always used with spermicide)
  • Acceptable forms of secondary contraceptions, when used along with a barrier method:
  • Hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e. "Mini-pill")
  • Tubal ligation
  • Partner's vasectomy
  • Intrauterine device (IUD) (non-progesterone T)
  • Vaginal sponge (containing spermicide)
  • 100% commitment to abstinence
  • Unacceptable forms of contraception for women of childbearing potential:
  • Oral contraception containing progestins only
  • IUD progesterone T
  • Female condom
  • Natural family planning (rhythm method) or breastfeeding
  • Fertility awareness
  • Withdrawal
  • Cervical shield
  • Willing to abstain from smoking
  • Willing to complete a daily pill diary

Who cannot join

  • 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
  • Any of the following prior therapies:
  • Chemotherapy =< 4 weeks prior to registration
  • Mitomycin C/nitrosoureas =< 6 weeks prior to registration
  • Immunotherapy =< 4 weeks prior to registration
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  • Biologic therapy =< 4 weeks prior to registration
  • Radiation therapy =< 4 weeks prior to registration
  • Radiation to > 25% of bone marrow
  • Failure to fully recover from acute, reversible effects of prior therapy regardless of interval since last treatment
  • New York Heart Association classification III or IV
  • Seizure disorder
  • Central nervous system (CNS) metastases if not stable for at least 2-3 months based on imaging, clinical assessment, and use of steroids, or seizure disorder
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception until 12 months after last study drug dose
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
  • Current therapy with a CYP3A4 inhibitor or inducer
  • Immunocompromised patients (other than that related to the use of corticosteroids) including patients receiving highly active antiretroviral therapy (HAART) treatment
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
  • History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
  • More than 2 prior chemotherapy regimens for the current metastatic malignancy; full dose chemotherapy used in conjunction with concurrent radiation therapy will be included as prior therapy; Note: prior hormonal therapy (e.g. leuprolide, aromatase inhibitors, tamoxifen) will be allowed and not included as a prior chemotherapy
  • Previous therapy with a hedgehog inhibitor

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Phase I Trial of the Combination of Vismodegib GDC-0449 and Erlotinib +/- Gemcitabine

This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with erlotinib hydrochloride with or without gemcitabine hydrochloride may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 with or without gemcitabine hydrochloride in patients with unresectable solid tumors.

SECONDARY OBJECTIVES:

  1. To describe the adverse events profile associated with these treatment regimens.

II. To describe the responses in patients treated with these regimens. III. To assess the effect of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 on selected biomarkers in circulating tumor cells and tumor biopsy samples from patients with metastatic pancreatic cancer.

IV. To assess the effect of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 on fludeoxyglucose F 18 positron emission tomography imaging in patients with metastatic pancreatic cancer.

  1. To study the association between clinical (toxicity and/or tumor response or activity) and biologic (pharmacodynamic) results associated with erlotinib hydrochloride and Hedgehog antagonist GDC-0449 in patients with metastatic pancreatic cancer.

OUTLINE: This is a dose-escalation study of erlotinib hydrochloride.

Patients receive Hedgehog antagonist GDC-0449 orally (PO) once daily (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.

Patients treated at the maximum tolerated dose undergo fludeoxyglucose F 18 positron emission tomography at baseline and on day 28. These patients also undergo tumor tissue and blood sample collection at baseline and periodically during study for correlative laboratory studies. Samples are analyzed for tyrosine phosphorylated or total MAP-K, EGFR, AKT, and other potential biomarkers of activity/response and for levels of genes transcriptionally activated (e.g., BCL-2, GLI, BFL-1/A1, 4-1BB, PTC1) by immunofluorescence, IHC, and quantitative-PCR.

After completion of study therapy, patients are followed at 3 months.

Being tested
Diagnostic Laboratory Biomarker Analysis, Erlotinib Hydrochloride, Gemcitabine Hydrochloride, Vismodegib
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic Laboratory Biomarker AnalysisOther

    Correlative studies

  • Erlotinib HydrochlorideDrug

    Also called CP 358, CP-358, Cp-358,774, CP358

    Given PO

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar

    Given IV

  • VismodegibDrug

    Also called Erivedge, GDC 0449, GDC-0449, GDC0449

    Given PO

Study groups in NCT00878163
Study groupRoleWhat they receive
Treatment (vismodegib, erlotinib hydrochloride, gemcitabine)ExperimentalPatients 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.
Receives: Other: Diagnostic Laboratory Biomarker Analysis; Drug: Erlotinib Hydrochloride; Drug: Gemcitabine Hydrochloride; Drug: Vismodegib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    DLT will be defined as an adverse event, according to CTCAE version 3.0, attributed (definitely, probably, or possibly to the study treatment.

    Measured: 28 days

Secondary outcomes (7)

  1. Adverse events as assessed by NCI CTCAE v3.0

    The number and severity of all adverse events (overall, and by dose-level) will be tabulated and summarized.

    Measured: Up to 3 months after completion of study treatment

  2. Toxicity, defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, graded using the NCI CTCAE version 3.0

    Measured: Up to 3 months after completion of study treatment

  3. Response as assessed by modified RECIST criteria

    Summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease.

    Measured: Up to 3 months after completion of study treatment

  4. Time until treatment related grade 3+ toxicity

    Measured: Up to 3 months after completion of study treatment

  5. Time until hematologic nadirs (WBC, ANC, platelets)

    Measured: Up to 3 months after completion of study treatment

  6. Time to progression

    Measured: Up to 3 months after completion of study treatment

  7. Time to treatment failure

    Measured: From registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2009 (estimated)
  2. Study start31 Mar 2009
  3. Primary completion22 Jan 2013
  4. Study completion6 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00878163
Sponsor's protocol ID
NCI-2011-01400
Other IDs
NCI-2011-01400, CDR0000638302, MAYO-MC0811, MC0811, 8231, P30CA015083, P50CA102701, U01CA069912
Status last verified
Sep 2026
First submitted
7 Apr 2009
Last updated
8 Sep 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Diagnostic Laboratory Biomarker Analysis, Erlotinib Hydrochloride and Gemcitabine Hydrochloride in people with Adult Solid Neoplasm and Pancreatic Acinar Cell Carcinoma, run by National Cancer Institute (NCI) at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00878163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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