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A Safety, Tolerability, And Pharmacokinetic Trial With CVX-241 In Patients With Advanced Solid Tumors

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NCT01004822

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Premiere Oncology of Arizona
Scottsdale, Arizona, 85258 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
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 solid tumors unresponsive to current therapy or for which there is no
standard therapy.

- Stage 2 only: Histologically or cytologically documented EOC or PPC with 3 previous anti-cancer therapies, but at least 1 prior platinum containing regimen.

- Adequate coagulation, liver, and renal function.

- Candidate for Dynamic Contrast-Enhanced Magnetic Resonance Imaging [DCE-MRI]
evaluation

- Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1

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

- History of clinically significant toxicity to Vascular Endothelial Growth Factor
[VEGF] inhibition.

- Evidence of bleeding problems.

- Uncontrolled hypertension.

- Patients with primary brain cancer and/or non-small cell lung cancer of squamous cell
histology

NCT01004822
Pfizer
Terminated
A Safety, Tolerability, And Pharmacokinetic Trial With CVX-241 In Patients With Advanced Solid Tumors

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A Safety, Tolerability, And Pharmacokinetic Trial With CVX-241 In Patients With Advanced Solid Tumors
A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Study Of Cvx-241, A Selective Angiopoietin-2 And Vascular Endothelial Growth Factor Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors
The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when given as weekly infusions to adult patients with advanced solid tumors.
The study was prematurely discontinued on 14 September 2011 due to no significant pharmacological effects (safety/PD/efficacy) through 25 mg/kg cohort, the T1/2 based on VEGF binding was shorter than expected and the current and/or higher doses were not considered feasible for further development. There were no safety concerns associated with the decision to terminate the program/study.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
  • Drug: CVX-241
    0.3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
    Other Name: PF-05057459
  • Drug: CVX-241
    1 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
    Other Name: PF-05057459
  • Drug: CVX-241
    3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
    Other Name: PF-05057459
  • Drug: CVX-241
    6 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
    Other Name: PF-05057459
  • Drug: CVX-241
    12 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
    Other Name: PF-05057459
  • Drug: CVX-241
    15 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
    Other Name: PF-05057459
  • Drug: CVX-241
    18 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
    Other Name: PF-05057459
  • Drug: CVX-241
    25 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
    Other Name: PF-05057459
Experimental: Active Drug
Weekly infusions of CVX-241 at specified doses
Interventions:
  • Drug: CVX-241
  • Drug: CVX-241
  • Drug: CVX-241
  • Drug: CVX-241
  • Drug: CVX-241
  • Drug: CVX-241
  • Drug: CVX-241
  • Drug: CVX-241
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed solid tumors unresponsive to current therapy or for which there is no standard therapy.
  • Stage 2 only: Histologically or cytologically documented EOC or PPC with < or equal to 3 previous anti-cancer therapies, but at least 1 prior platinum containing regimen.
  • Adequate coagulation, liver, and renal function.
  • Candidate for Dynamic Contrast-Enhanced Magnetic Resonance Imaging [DCE-MRI] evaluation
  • Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1

Exclusion Criteria:

  • History of clinically significant toxicity to Vascular Endothelial Growth Factor [VEGF] inhibition.
  • Evidence of bleeding problems.
  • Uncontrolled hypertension.
  • Patients with primary brain cancer and/or non-small cell lung cancer of squamous cell histology
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01004822
B1561001
CVX-241-101 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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