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NCT00596648 · ClinicalTrials.gov registry record · Phase 1

A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 study, sponsored by Exelixis.

Completed
Registry status
Phase 1
Development phase
92
Enrollment target

NCT00596648 is a Phase 1 study that has completed, run by Exelixis. The registered enrollment target is 92 participants.

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The verdict

NCT00596648, a Phase 1 study, has completed, sponsored by Exelixis.

COMPLETED
Registry status
Phase 1
Development phase
92 participants
Enrollment target

Study Summary

The study consisted of a Phase 1 dose escalation/dose de-escalation portion to determine a safe and tolerable combination dose(s) of cabozantinib and erlotinib, and a Phase 2 Simon optimal 2-stage design portion with randomized assignment of subjects in an equal ratio to determine the objective response rate (ORR) of cabozantinib with or without erlotinib in subjects with non-small cell lung cancer (NSCLC) who have progressed after responding to treatment with erlotinib. The doses of cabozantinib used in this study were based on the salt weight, not the freebase weight.

Interventions

  • DRUG erlotinib
  • DRUG XL184

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2008-02-12
Est. Completion 2012-08-02
Phase Phase 1

Sponsor

Exelixis

48 total trials

What the Registry Record Tells You About NCT00596648

The ClinicalTrials.gov registry entry for NCT00596648 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exelixis, which has 48 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which erlotinib is the first listed.

NCT00596648 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00596648 about?

NCT00596648 is a clinical study titled "A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)". The study consisted of a Phase 1 dose escalation/dose de-escalation portion to determine a safe and tolerable combination dose(s) of cabozantinib and erlotinib, and a Phase 2 Simon optimal 2-stage design portion with randomized assignment of subjects in an equal ratio to determine the objective resp...

What is the current status of trial NCT00596648?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2008-02-12. Estimated completion is 2012-08-02.

What interventions are being tested in trial NCT00596648?

The interventions under investigation include: erlotinib (DRUG), XL184 (DRUG).

Who is sponsoring clinical trial NCT00596648?

This trial is sponsored by Exelixis, which has 48 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.