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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: Completed Phase 1 study, sponsored by Genentech.

NCT01106599 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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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
Genentech

332 total trials

What the finished NCT01106599 record still lists

NCT01106599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which GDC-0623 is the first listed.

NCT01106599 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01106599's enrollment target sits among peer trials

61 828th of 2000 higher than 1,170 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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Source: ClinicalTrials.gov NCT01106599, the US trial registry maintained by the National Library of Medicine. NCT01106599 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.