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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01004822
First received: October 28, 2009
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: CVX-241
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Determine maximum tolerated dose of weekly infusions of CVX-241 (PF-05057459) in patients with advanced solid tumors [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Dose Limiting Toxicities [DLTs], Adverse Events [AEs] and Serious Adverse Events [SAEs] [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters of CVX-241 (AUC, Cmax, Cmin, Clearance, and T1/2) [ Time Frame: Days 1, 5, 8, 15, and 22 ] [ Designated as safety issue: No ]
  • Change from baseline in serum Ang2 and plasma VEGF concentrations during and following CVX-241 therapy [ Time Frame: Baseline - Safety Follow-up ] [ Designated as safety issue: No ]
  • Immunogenicity determined by measuring anti-CVX-241 antibodies following therapy [ Time Frame: Baseline - Safety Follow-Up ] [ Designated as safety issue: Yes ]
  • Response rate (Stable Disease [SD], Partial Response [PR], Complete Response [CR]) by Response Evaluation Criterion In Solid Tumors [RECIST] and tumor response as determined by CA-125 in patients with EOC/PPC (stage 2). [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug
Weekly infusions of CVX-241 at specified doses
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004822

Locations
United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85258
United States, California
Pfizer Investigational Site
Santa Monica,, California, United States, 90404
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01004822     History of Changes
Other Study ID Numbers: B1561001, CVX-241-101
Study First Received: October 28, 2009
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Treatment Non-Randomized Single Group Assignment Safety Study Neoplasms Carcinoma Cancer Malignancy

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014