Trials / Completed
CompletedNCT00853372
AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib
Phase 2 Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Sunitinib Malate in Combination With AMG 386 as First Line or Second Line Therapy for Subjects With Metastatic Renal Cell Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sunitinib | Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants. |
| DRUG | Trebananib | Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death. |
Timeline
- Start date
- 2009-05-28
- Primary completion
- 2011-08-08
- Completion
- 2019-06-25
- First posted
- 2009-03-02
- Last updated
- 2020-07-01
- Results posted
- 2020-07-01
Source: ClinicalTrials.gov record NCT00853372. Inclusion in this directory is not an endorsement.