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CVX-060

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |Pfizer, Inc.|Last Updated: Jan 26, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00879684Safety And PK Study Of CVX-060 In Patients With Advanced Solid TumorsPHASE1 COMPLETED 34Jan 1, 2008Apr 1, 2011Jan 26, 20154 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Baseline (Day 0) up to 30 days after last dose of study medication

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.

Secondary Endpoints
Maximum Observed Serum Concentration (Cmax)
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
CVX-060BIOLOGICALWeekly, intravenous dose
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy. * Adequate coagulation, liver, and renal function. * Candidate for DCE-MRI evaluations. * ECOG (Eastern Cooperative Oncology Group) performance status of 0 ...

Countries:United States
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