CompletedPhase 2

STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Argentina, Australia, Austria1,232 participantsStarted 2011-07-01

Plain-language summary

This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients, \>/=18 years of age * Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Exclusion Criteria: * Concurrent anti-tumor therapy * Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment * Uncontrolled medical illness

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs)

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Exposure to Study Treatment: Duration on Treatment

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Exposure to Study Treatment - Dose Intensity

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Trial details

NCT IDNCT01367665

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-14

Results submitted2018-06-13

View on ClinicalTrials.gov More Basal Cell Carcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs)

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Exposure to Study Treatment: Duration on Treatment

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Exposure to Study Treatment - Dose Intensity

Timeframe: Baseline to the data cut-off of 14 June 2017 (up to 6 years)