Basal Cell Carcinoma, Metastatic Colorectal Cancer, Ovarian Cancer
Conditions
Keywords
Hedgehog pathway inhibitor
Brief 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.
Interventions
DRUGVismodegib
Vismodegib was supplied in capsules.
DRUGFOLFOX
FOLFOX (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and oxaliplatin \[OX\]) was supplied as solutions for intravenous administration.
DRUGFOLFIRI
FOLFIRI (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and irinotecan \[IRI\]) was supplied as solutions for intravenous administration.
DRUGBevacizumab
Bevacizumab was supplied as a solution for intravenous administration.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Participants Who Experienced at Least One Adverse Event | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | The investigator used the adverse event (AE) grading (severity) scale found in the NCI CTCAE v3.0 to assess AE severity, with grades ranging from 1 to 5 having the following descriptions: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is very severe, life threatening or disabling, and Grade 5 is death related to AE. |
Countries
United States
Contacts
STUDY_DIRECTORJosina Reddy, MD, PhD
Genentech, Inc.
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vismodegib 150 mg Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Vismodegib 150 mg |
|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 15.4 |
| Race/Ethnicity, Customized White | 19 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 19 |
| other Total, other adverse events | 17 / 19 |
| serious Total, serious adverse events | 3 / 19 |
Outcome results
Primary
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event
Time frame: Baseline until 30 days following the last administration of study treatment
Population: Safety population: All participants who had received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vismodegib 150 mg | Percentage of Participants Who Discontinued Treatment Due to an Adverse Event | 10.5 Percentage of participants |
Primary
Percentage of Participants Who Experienced at Least 1 Adverse Event
Time frame: Baseline until 30 days following the last administration of study treatment
Population: Safety population: All participants who had received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vismodegib 150 mg | Percentage of Participants Who Experienced at Least 1 Adverse Event | 89.5 Percentage of participants |
Secondary
Incidence and Severity of All Adverse Events and Serious Adverse Events
Time frame: 30 days following the last administration of study treatment
Secondary
Incidence of Adverse Events Leading to GDC-0449 Discontinuation
Time frame: 30 days following the last administration of study treatment