CompletedPhase 2

A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study

United States19 participantsStarted 2009-09-03

Plain-language summary

This was a multicenter, open-label extension study. Patients who received vismodegib (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who continued to receive vismodegib at the time the parent study closed were eligible for continued treatment in this protocol.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

This study only enrolled participants who took part in previous studies of vismodegib conducted by Genentech. Inclusion Criteria: * Completed vismodegib treatment within 2-4 weeks in a Genentech-sponsored parent study or continued to receive vismodegib at the time the Genentech-sponsored parent study closed. * Expectation by the investigator that the participant may continue to benefit from additional vismodegib treatment. Exclusion Criteria: * Intervening anti-tumor therapy not specified in the parent study (ie, non-protocol-specified chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).

What they're measuring

Incidence of Participants Who Experienced at Least One Adverse Event

Timeframe: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)

Incidence of Participants Who Discontinued Treatment Due to an Adverse Event

Timeframe: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)

Trial details

NCT IDNCT00959647

SponsorGenentech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-01-09

Results submitted2014-12-23

View on ClinicalTrials.gov More Ovarian Cancer trials

Who can participate

Age range18 Years

SexALL

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

Incidence of Participants Who Experienced at Least One Adverse Event

Timeframe: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)

Incidence of Participants Who Discontinued Treatment Due to an Adverse Event

Timeframe: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)