Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors

NCT00879684

Last updated date
Study Location
Scottsdale Medical Imaging, Ltd.
Scottsdale, Arizona, 85255, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, Malignancy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, MalignancySafety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
NCT00879684
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Advanced Information
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
  • Advanced Solid Tumors
  • Neoplasms
  • Carcinoma
  • Cancer
  • Malignancy
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
 (submitted: May 12, 2011)
34
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2009)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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