Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00879684
First received: April 9, 2009
Last updated: January 15, 2015
Last verified: January 2015
  Purpose

The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.


Condition Intervention Phase
Advanced Solid Tumors
Neoplasms
Carcinoma
Cancer
Malignancy
Biological: CVX-060
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 Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) 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:
  • Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) up to 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.


Secondary Outcome Measures:
  • Maximum Observed Serum Concentration (Cmax) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ] [ Designated as safety issue: No ]
  • Serum Decay Half-Life (t1/2) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ] [ Designated as safety issue: No ]
    Serum decay half-life is the time measured for the serum concentration to decrease by one half.

  • Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ] [ Designated as safety issue: No ]
    AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).

  • Apparent Volume of Distribution (Vss) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ] [ Designated as safety issue: No ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.

  • Apparent Clearance (CL) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ] [ Designated as safety issue: No ]
    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.

  • Time to Reach Maximum Observed Serum Concentration (Tmax) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ] [ Designated as safety issue: No ]
  • Recommended Phase 2 Dose (RP2D): Stage 1 [ Time Frame: Baseline (Day 0) up to 42 days after the last dose of study medication ] [ Designated as safety issue: No ]
    RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.

  • Number of Participants With Anti-CVX-060 Antibodies [ Time Frame: Baseline (Day 0) up to 42 days after last dose ] [ Designated as safety issue: Yes ]
  • Number of Samples From Participants With Anti-CVX-060 Antibodies [ Time Frame: Baseline (Day 0) up to 42 days after last dose ] [ Designated as safety issue: Yes ]
  • Number of Participants With Best Overall Response (BOR) [ Time Frame: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133) ] [ Designated as safety issue: No ]
    BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported.


Enrollment: 34
Study Start Date: January 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: CVX-060
Weekly, intravenous dose

  Eligibility

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

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 evaluations.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

Exclusion Criteria:

  • Evidence of significant bleeding problems.
  • History of certain gastrointestinal problems including fistula and abscess.
  • Chronic, uncontrolled hypertension.
  • Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
  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: NCT00879684

Locations
United States, Arizona
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85258
Scottsdale Medical Imaging, Ltd.
Scottsdale, Arizona, United States, 85255
United States, California
Premiere Oncology, A Medical Corporation
Santa Monica,, California, United States, 90404
United States, Pennsylvania
Fox Chase Cancer Center
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: NCT00879684     History of Changes
Other Study ID Numbers: B1131002, CVX-060-101
Study First Received: April 9, 2009
Results First Received: January 15, 2015
Last Updated: January 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Tumors
CVX-060

ClinicalTrials.gov processed this record on August 03, 2015