A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors

NCT00879554

Last updated date
Study Location
Pfizer Investigational Site
Scottsdale, Arizona, 85258, 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 evaluation.

- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

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


- Evidence of bleeding problems.


- Uncontrolled hypertension.


- Certain gastrointestinal problems including fistula and abscess.


- Patients with primary brain cancer.

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Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, MalignancyA Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors
NCT00879554
  1. Scottsdale, Arizona
  2. Santa Monica,, California
  3. Philadelphia, Pennsylvania
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18 Years+
years
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Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, MalignancySafety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
NCT00879684
  1. Scottsdale, Arizona
  2. Scottsdale, Arizona
  3. Santa Monica,, California
  4. Philadelphia, Pennsylvania
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Advanced Information
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
  • Advanced Solid Tumors
  • Neoplasms
  • Carcinoma
  • Cancer
  • Malignancy
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
 (submitted: April 9, 2009)
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:

  • 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.

Exclusion Criteria:

  • Evidence of bleeding problems.
  • Uncontrolled hypertension.
  • Certain gastrointestinal problems including fistula and abscess.
  • Patients with primary brain cancer.
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 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
Study Director:Pfizer CT.gov Call CenterPfizer
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