- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00879684
Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
January 15, 2015 updated by: Pfizer
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
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85258
- Premiere Oncology of Arizona
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Scottsdale, Arizona, United States, 85255
- Scottsdale Medical Imaging, Ltd.
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California
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Santa Monica,, California, United States, 90404
- Premiere Oncology, A Medical Corporation
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 or 1.
Exclusion Criteria:
- Evidence of significant bleeding problems.
- History of certain gastrointestinal problems including fistula and abscess.
- Chronic, uncontrolled hypertension.
- Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Weekly, intravenous dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time Frame: 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.
|
Baseline (Day 0) up to 30 days after last dose of study medication
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Serum Concentration (Cmax)
Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
|
Serum Decay Half-Life (t1/2)
Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
|
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)]
Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Apparent Volume of Distribution (Vss)
Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Apparent Clearance (CL)
Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).
Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
|
Recommended Phase 2 Dose (RP2D): Stage 1
Time Frame: Baseline (Day 0) up to 42 days after the last dose of study medication
|
RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings.
DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.
|
Baseline (Day 0) up to 42 days after the last dose of study medication
|
Number of Participants With Anti-CVX-060 Antibodies
Time Frame: Baseline (Day 0) up to 42 days after last dose
|
Baseline (Day 0) up to 42 days after last dose
|
|
Number of Samples From Participants With Anti-CVX-060 Antibodies
Time Frame: Baseline (Day 0) up to 42 days after last dose
|
Baseline (Day 0) up to 42 days after last dose
|
|
Number of Participants With Best Overall Response (BOR)
Time Frame: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
|
BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response (CR): disappearance of all lesions.
Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions.
PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions.
Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start.
CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response.
SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks.
Participants with >=3 treatments cycles were reported.
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Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
April 9, 2009
First Submitted That Met QC Criteria
April 9, 2009
First Posted (Estimate)
April 10, 2009
Study Record Updates
Last Update Posted (Estimate)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 15, 2015
Last Verified
January 1, 2015
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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