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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 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 52 participants.

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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.

Interventions

  • DRUG Rosiglitazone
  • DRUG Vismodegib
  • DRUG Norethindrone/ethinyl estradiol

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2010-11
Est. Completion 2012-03
Phase Phase 1

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT01209143

The ClinicalTrials.gov registry entry for NCT01209143 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Rosiglitazone is the first listed.

NCT01209143 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.