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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: Completed Phase 1 study, sponsored by Exelixis.
NCT00596648 is a Phase 1 study that has completed, run by Exelixis. The registered enrollment target is 92 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment duration was defined as the number of days from the first dose to the last dose (measured in weeks), including any days of treatment interruption that occurred before the last dose of study drug.
Interventions
- DRUG erlotinib
- DRUG XL184
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2008-02-12 |
| Est. Completion | 2012-08-02 |
| Phase | Phase 1 |
What the finished NCT00596648 record still lists
NCT00596648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 2 interventions - of which erlotinib is the first listed.
NCT00596648 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00596648's enrollment target sits among peer trials
92 625th of 2000 higher than 1,375 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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