Phase 2
Completed N=19
A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
Source: ClinicalTrials.gov NCT00959647 ↗Enrolled (actual)
19
Serious AEs
15.8%
Results posted
Jan 2015
Primary outcomePrimary: Incidence of Participants Who Experienced at Least One Adverse Event — 17 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Participants Who Experienced at Least One Adverse Event |
17 | — |
| PRIMARY Incidence of Participants Who Discontinued Treatment Due to an Adverse Event |
2 | — |
| SECONDARY Incidence of All Adverse Events and Serious Adverse Events by Highest Severity Grade According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 |
17; 4; 7; 6 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00959647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.