Experimental drug cocktail targets Hard-to-Treat cancers
NCT ID NCT00878163
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 Hide 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.
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.
- Can a new drug shrink advanced solid tumors?
- Can a Triple-Drug combo outsmart pancreatic cancer?
- A Spleen-Saving surgery for pancreatic cancer faces its biggest test
- Can we decode pancreatic cancer's resistance to chemotherapy?
- Can a genetic test choose the right chemo for pancreatic cancer?
- Can a triple therapy outsmart pancreatic cancer?