Experimental drug cocktail targets Hard-to-Treat cancers

NCT ID NCT00878163

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This early-phase study tests a combination of two targeted drugs (vismodegib and erlotinib) with or without a standard chemotherapy drug (gemcitabine) in people with advanced pancreatic cancer or other solid tumors that cannot be removed by surgery. The main goal is to find the safest dose and understand side effects. The study involves 55 adults whose cancer has not responded to other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

55 people

The number who actually took part.

Started

Mar 2009

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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 * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Adult solid neoplasm are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.