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Trial record 1 of 1 for:    NCT00879684
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Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00879684
Recruitment Status : Completed
First Posted : April 10, 2009
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 9, 2009
First Posted Date  ICMJE April 10, 2009
Results First Submitted Date  ICMJE January 15, 2015
Results First Posted Date  ICMJE January 26, 2015
Last Update Posted Date January 26, 2015
Study Start Date  ICMJE January 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2009)
  • To determine safety and tolerability of CVX-060 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors [ Time Frame: Throughout duration of study ]
  • To identify and characterize CVX-060-related adverse events (AEs) [ Time Frame: Throughout duration of study ]
Change History Complete list of historical versions of study NCT00879684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • Maximum Observed Serum Concentration (Cmax) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ]
  • 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) ]
    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) ]
    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) ]
    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) ]
    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) ]
  • Recommended Phase 2 Dose (RP2D): Stage 1 [ Time Frame: Baseline (Day 0) up to 42 days after the last dose of study medication ]
    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 ]
  • Number of Samples From Participants With Anti-CVX-060 Antibodies [ Time Frame: Baseline (Day 0) up to 42 days after last dose ]
  • 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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2009)
  • To evaluate the plasma pharmacokinetics (PK) of CVX-060 [ Time Frame: Days 0, 4, 7, 14, 28 ]
  • To determine a recommended Phase 2 dose of CVX-060 [ Time Frame: End of study ]
  • To evaluate the potential for immunogenicity of CVX-060 [ Time Frame: Day 0, 14, 1st day of each cycle, EOS, 42 Day FU ]
  • To document any preliminary evidence of antitumor activity [ Time Frame: Every 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors
  • Neoplasms
  • Carcinoma
  • Cancer
  • Malignancy
Intervention  ICMJE Biological: CVX-060
Weekly, intravenous dose
Study Arms  ICMJE Experimental: 1
Intervention: Biological: CVX-060
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2011)
34
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2009)
45
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00879684
Other Study ID Numbers  ICMJE B1131002
CVX-060-101 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP