A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors
Sponsor study identifier
Secondary identifiers
OTHER · Alias Study Number
interventional
34
1 country
4
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Actual (reported)Study Completion
April 2011
Actual (reported)The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 9, 2009
Actual (reported)April 10, 2009
Actual (reported)April 2011
Actual (reported)April 2011
Actual (reported)January 26, 2015
Actual (reported)Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Baseline (Day 0) up to 30 days after last dose of study medication
Maximum Observed Serum Concentration (Cmax)
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Weekly, intravenous dose
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Scottsdale Medical Imaging, Ltd.
Scottsdale, Arizona, 85255, United States
Premiere Oncology of Arizona
Scottsdale, Arizona, 85258, United States
Premiere Oncology, A Medical Corporation
Santa Monica, California, 90404, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Designation of outcomes as primary, secondary was based on study team's input as study did not specify them as primary or secondary.
Pfizer CT.gov Call Center
Pfizer
34 participants (actual enrollment reported by the registry).
First Submitted
April 9, 2009
First Posted
April 10, 2009
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Serum Decay Half-Life (t1/2)
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Apparent Volume of Distribution (Vss)
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Apparent Clearance (CL)
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Contact the study team to confirm eligibility.
Primary Completion
April 2011
Actual (reported)Study Completion
April 2011
Actual (reported)Last Updated
January 26, 2015
Results First Posted
January 26, 2015
Record last verified: 2015-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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