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



Status:Terminated
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2010
End Date:May 2014

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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

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.

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
We found this trial at
3
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Scottsdale, Arizona 85260
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Philadelphia, Pennsylvania 19111
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Santa Monica, California 90404
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Santa Monica, CA
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