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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Epithelial Ovarian Cancer (EOC) or Primary Peritoneal Cancer (PPC)

Thank you

Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine maximum tolerated dose of weekly infusions of CVX-241 (PF-05057459) in patients with advanced solid tumors

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1561001

NCT ID:

NCT01004822

Start Date:

March 2010

Completion Date:

August 2013

Related Keywords:

  • Advanced Solid Tumors
  • Epithelial Ovarian Cancer (EOC) or Primary Peritoneal Cancer (PPC)
  • Treatment Non-Randomized Single Group Assignment Safety Study Neoplasms Carcinoma Cancer Malignancy
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535