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NCT01106599 · ClinicalTrials.gov registry record · Phase 1

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1 study, sponsored by Genentech.

Completed
Registry status
Phase 1
Development phase
61
Enrollment target

NCT01106599 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 61 participants.

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The verdict

NCT01106599, a Phase 1 study, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 1
Development phase
61 participants
Enrollment target

Study Summary

This is an open-label, multicenter, Phase I dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) followed by an expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0623 administered orally on a 21 day on/7-day off dosing schedule.

Interventions

  • DRUG GDC-0623

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2010-04
Est. Completion 2014-08
Phase Phase 1

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT01106599

The ClinicalTrials.gov registry entry for NCT01106599 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 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 1 intervention - of which GDC-0623 is the first listed.

NCT01106599 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01106599 about?

NCT01106599 is a clinical study titled "A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors". This is an open-label, multicenter, Phase I dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) followed by an expans...

What is the current status of trial NCT01106599?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2010-04. Estimated completion is 2014-08.

What interventions are being tested in trial NCT01106599?

The interventions under investigation include: GDC-0623 (DRUG).

Who is sponsoring clinical trial NCT01106599?

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.