A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors
NCT00879554
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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 evaluation.
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
- Evidence of bleeding problems.
- Uncontrolled hypertension.
- Certain gastrointestinal problems including fistula and abscess.
- Patients with primary brain cancer.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors | |||
| Official Title ICMJE | A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, In Patients With Advanced Solid Tumors | |||
| Brief Summary | The purpose of the study is to determine safety and tolerability of CVX-045 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-045
Weekly, intravenous dose | |||
| Study Arms ICMJE | Experimental: 1
Intervention: Biological: CVX-045 | |||
| 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 | 40 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | November 2010 | |||
| Actual Primary Completion Date | March 2009 (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 | NCT00879554 | |||
| Other Study ID Numbers ICMJE | B1121003 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||