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New pill shrinks tough skin cancers in early trial

NCT ID NCT00833417

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase II trial tested the drug vismodegib in 104 people with advanced basal cell carcinoma, a type of skin cancer that had spread or could not be surgically removed. Participants took a daily capsule until their cancer worsened or side effects became too severe. The study measured how many patients had their tumors shrink or disappear. Results showed that many patients responded, but the drug is not a cure and requires ongoing treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vismodegib (GDC-0449) - a targeted cancer drug taken as a capsule
What this could lead to
If successful, this could provide a new treatment option for people with advanced basal cell carcinoma that cannot be removed by surgery.
What could go wrong
This is a Phase II trial with only 104 participants, so results may not hold in larger groups. The drug can cause side effects like muscle spasms, hair loss, and fatigue, and tumors may still grow or require lifelong treatment.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

104 people

The number who actually took part.

Started

Feb 2009

Finished

Apr 2014

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Men and women ≥ 18 years of age. * For patients with metastatic basal cell carcinoma (BCC), histological confirmation of distant BCC metastasis (eg, lung, liver, lymph nodes, or bone), with metastatic disease that is Response Evaluation Criteria in Solid Tumors (RECIST) measurable using computed tomography (CT) or magnetic resonance imaging (MRI). * For patients with locally advanced BCC, histologically confirmed disease that is considered to be inoperable. * For patients with locally advanced BCC, radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate. For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation. * For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of vismodegib (GDC-0449). * For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of vismodegib. Exclusion Criteria: * Prior treatment with vismodegib or other Hedgehog pathway inhibitors. * Pregnancy or lactation. * Life expectancy of \< 12 weeks. * Patients with superficial multifocal BCC who may be considered unresectable due to breadth of involvement. * Concurrent non-protocol-specified anti-tumor therapy (eg, chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy). * Recent, current, or planned participation in an experimental drug study. * History of other malignancies within 3 years of the first day of treatment with vismodegib in this study (Day 1), except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix. * Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.

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Conditions

The condition(s) this trial relates to.

basal cell carcinoma basal cell neoplasm skin basal cell carcinoma

As listed by the trial registrant

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

Basal cell carcinoma

Contacts and locations

Locations

  • Advanced Derm & Cosmetic Surg

    Ormond Beach, Florida, 32174, United States

  • Angeles Clinic & Rsch Inst

    Los Angeles, California, 90025, United States

  • Arthur G. James Cancer Hosp

    Columbus, Ohio, 43210, United States

  • Centre Hospitalier Lyon Sud; Dermatologie

    Pierre-Bénite, 69495, France

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Med Center

    Lebanon, New Hampshire, 03756, United States

  • Hopital Claude Huriez

    Lille, 59037, France

  • Hopital Hotel Dieu Et Hme; Clinique Dermatologique

    Nantes, 44093, France

  • Hopital Saint Louis; Dermatologie 1

    Paris, 75475, France

  • Institut Jules Bordet

    Anderlecht, 1070, Belgium

  • Johns Hopkins Univ Med Center

    Baltimore, Maryland, 21231, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4095, United States

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Rochester; Medical Oncology

    Rochester, Minnesota, 55905, United States

  • Mount Sinai School of Medicine; Dermatology

    New York, New York, 10029, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Poole Hospital; Dorset Cancer Centre

    Poole, BH15 2JB, United Kingdom

  • Princess AleXandra Hospital; Department of Medical Oncology

    Woolloongabba, Queensland, 4102, Australia

  • Royal Marsden Hospital - London

    London, SW3 6JJ, United Kingdom

  • Sint Augustinus Wilrijk, Apotheek

    Wilrijk, 2610, Belgium

  • Siouxland Hematology/Oncology

    Sioux City, Iowa, 51101, United States

  • St George Hospital

    Kogarah, New South Wales, 2217, Australia

  • Stanford University Medical Center

    Palo Alto, California, 94304, United States

  • The Sarah Cannon Research Inst

    Nashville, Tennessee, 37203, United States

  • Univ No Carolina School of Med; Physicians Office Bldg

    Chapel Hill, North Carolina, 27599-7305v, United States

  • Univ of Calif-San Francisco

    San Francisco, California, 94115, United States

  • Univ of Colorado Hlth Sci Ctr

    Aurora, Colorado, 80045, United States

  • Universitaets-Hautklinik Tuebingen

    Tübingen, 72076, Germany

  • Universitatsklinikum Wurzburg; Derma

    Würzburg, 97080, Germany

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

    Essen, 45122, Germany

  • Universitätsklinikum Schleswig

    Kiel, 24105, Germany

  • VA Southern Nevada Healthcare

    Las Vegas, Nevada, 89103, United States

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