PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
Status: | Terminated |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/10/2019 |
Start Date: | November 21, 2011 |
End Date: | March 27, 2014 |
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
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.
in patients that have received one prior systemic regimen for metastatic renal cell carcinoma
(mRCC) vs. axitinib alone.
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.
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.
Inclusion Criteria:
- Adult male or female patients with histologically or cytologically confirmed renal
cell cancer (RCC) with a component of clear cell subtype and evidence of metastasis
- Evidence of unidimensionally measurable disease
- Prior therapy: Part I: Having received 1 to 3 prior systemic regimens for treatment of
mRCC
- Part II: Evidence of disease progression following 1 prior regimen administered as 1st
line therapy for mRCC. The prior regimen must have contained one of the following:
VEGFR2 tyrosine kinase inhibitor (TKI) or other anti VEGF [Vascular Endothelial Growth
Factor] compounds, such as bevacizumab
- adequate bone marrow, liver and renal function
Exclusion Criteria:
Part I:
- Intolerant to prior AG 013736 therapy or prior treatment with compounds which contain
the core platform antibody as PF 04856884
Part II:
- Prior AG 013736 therapy, more than one systemic first-line regimen for the treatment
of mRCC and prior treatment with compounds which contain the core platform antibody as
PF 04856884
- major surgery <4 weeks or radiation therapy <2 weeks prior to start of therapy
- clinically significant gastrointestinal abnormalities
- current use or anticipated need for drugs that are known potent CYP3A4 inhibitors and
drugs that are known CYP3A4 or CYP1A2 inducers
- history of bleeding diathesis or coagulopathy
- Grade 3 or greater hemorrhage from any cause <4 weeks prior to screening;
- hemoptysis >½ teaspoon of blood per day within 2 weeks prior to screening.
We found this trial at
22
sites
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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