Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
NCT00879684
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Biological: CVX-060
Weekly, intravenous dose | |||
| Study Arms ICMJE | Experimental: 1
Intervention: Biological: CVX-060 | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 34 | |||
| Original Estimated Enrollment ICMJE | 45 | |||
| Actual Study Completion Date ICMJE | April 2011 | |||
| Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00879684 | |||
| Other Study ID Numbers ICMJE | B1131002 CVX-060-101 ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||