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NCT01209143 · ClinicalTrials.gov registry record · Phase 1
A Study of 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
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01209143: Completed Phase 1 study, sponsored by Genentech.
NCT01209143 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01209143, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study 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.
Primary Outcome
On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculat
Interventions
- DRUG Rosiglitazone
- DRUG Vismodegib
- DRUG Norethindrone/ethinyl estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01209143 record still lists
NCT01209143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 3 interventions - of which Rosiglitazone is the first listed.
NCT01209143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01209143 about?
NCT01209143 is a clinical study titled "A Study of 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". 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.
What is the current status of trial NCT01209143?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2010-11. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01209143?
The interventions under investigation include: Rosiglitazone (DRUG), Vismodegib (DRUG), Norethindrone/ethinyl estradiol (DRUG).
Who is sponsoring clinical trial NCT01209143?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01209143's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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