Trials / Terminated
TerminatedNCT01441414
PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
A PHASE II TRIAL OF PF-04856884 (CVX-060), A SELECTIVE ANGIOPOIETIN-2 (ANG-2) INHIBITOR IN COMBINATION WITH AG-013736 (AXITINIB) IN PATIENTS WITH PREVIOUSLY TREATED METASTATIC RENAL CELL CARCINOMA
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736) in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.
Detailed description
The study was prematurely discontinued on 06Nov2012 due to tolerability findings in patients treated in Part I of the study that have prompted the Sponsor to re-evaluate the strategic development of the program. An unexpected frequency of arterial thrombotic events (ATEs) and venous thrombotic events (VTEs) were reported in patients treated in Part I.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PF-04856884 | 15 mg/kg/week intravenously \[IV\] until toxicity or disease progression |
| DRUG | Axitinib (AG-013736) | 5 mg PO BID |
| DRUG | Axitinib (AG-013736) | 5 mg PO BID |
Timeline
- Start date
- 2011-11-21
- Primary completion
- 2014-03-27
- Completion
- 2014-03-27
- First posted
- 2011-09-27
- Last updated
- 2019-01-08
- Results posted
- 2016-01-18
Locations
29 sites across 2 countries: United States, Czechia
Source: ClinicalTrials.gov record NCT01441414. Inclusion in this directory is not an endorsement.