Trials / Completed
CompletedNCT00709995
A Study for Participants With Metastatic Renal Cell Carcinoma
Dose Finding and Randomized, Multicenter, Placebo-Controlled, Phase 2 Study of Enzastaurin and Sunitinib Versus Placebo and Sunitinib in Patients With Metastatic Renal Cell Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.
Detailed description
This is a multicenter, Phase 2 study of enzastaurin and sunitinib versus placebo and sunitinib as first-line therapy in participants with metastatic renal cell carcinoma, containing 2 parts. Part 1 is a safety lead-in study with 12 participants and possible dose escalation. Part 2 is a randomized, double-blind, Phase 2 study in 110 participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enzastaurin | Administered orally |
| DRUG | Sunitinib | Administered orally |
| DRUG | Placebo | Administered orally |
Timeline
- Start date
- 2008-06-30
- Primary completion
- 2010-02-15
- Completion
- 2018-09-05
- First posted
- 2008-07-03
- Last updated
- 2019-09-30
- Results posted
- 2019-09-30
Locations
4 sites across 4 countries: Austria, France, Italy, Poland
Source: ClinicalTrials.gov record NCT00709995. Inclusion in this directory is not an endorsement.