Trials / Completed
CompletedNCT01553656
Dose-Finding Study of Cabozantinib (XL184) in Japanese Subjects With Advanced Cancer
Phase 1 Multiple Ascending Dose Study of XL184 Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- Sponsor
- Exelixis · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics, pharmacogenomic (PGX) and preliminary efficacy following daily oral doses of cabozantinib (XL184) in Japanese patients with advanced or metastatic solid tumors. Also, the effect of XL184 in the treatment of non-small cell lung cancer (NSCLC) patients with various activating mutations will be evaluated at the recommended Phase 2 dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cabozantinib capsules | cabozantinib capsules administered as 25-mg and 100-mg strengths once-daily until disease progression |
| DRUG | cabozantinib tablets | cabozantinib tablets administered as 20-mg and 60-mg strengths once-daily until disease progression |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2015-05-01
- Completion
- 2015-07-01
- First posted
- 2012-03-14
- Last updated
- 2015-08-20
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01553656. Inclusion in this directory is not an endorsement.