At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 52 enrolled
Drug / intervention
Vismodegib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib, Open-Label, Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists
In Brief
A Phase 1 clinical trial evaluating Vismodegib, Rosiglitazone, and 1 other intervention for Solid Cancers. Completed, enrolled 52 participants across 3 sites.
Detailed Summary
This is a single-arm, multicenter, Phase Ib study designed to describe the effect of GDC-0449 on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with advanced solid tumors who are refractory to treatment or for whom no standard therapy exists.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Cancers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartNov 2010
Primary CompletionMar 2012
TodayJul 2026
First PostedSep 27, 2010
Enrollment StartNov 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.8 years ago
Interventions
Vismodegibdrug
Vismodegib was supplied in hard gelatin capsules.
Rosiglitazonedrug
Rosiglitazone was supplied in tablets.
Norethindrone/ethinyl estradioldrug
Norethindrone/ethinyl estradiol was supplied in tablets.