Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study Of PF-03732010 In Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00557505
First received: November 12, 2007
Last updated: February 21, 2012
Last verified: February 2012
Results First Received: January 10, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms
Intervention: Drug: PF-03732010

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PF-03732010 0.5 mg/kg Biweekly PF-03732010 infusion 0.5 milligram per kilogram (mg/kg) intravenously (IV) administered over 1 hour (hr) on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 1.0 mg/kg Biweekly PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-3732010 2.0 mg/kg Biweekly PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 4.0 mg/kg Biweekly PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 8.0 mg/kg Biweekly PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 15.0 mg/kg Biweekly PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 4.0 mg/kg Weekly PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 8.0 mg/kg Weekly PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 15.0 mg/kg Weekly PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).

Participant Flow:   Overall Study
    PF-03732010 0.5 mg/kg Biweekly     PF-03732010 1.0 mg/kg Biweekly     PF-3732010 2.0 mg/kg Biweekly     PF-03732010 4.0 mg/kg Biweekly     PF-03732010 8.0 mg/kg Biweekly     PF-03732010 15.0 mg/kg Biweekly     PF-03732010 4.0 mg/kg Weekly     PF-03732010 8.0 mg/kg Weekly     PF-03732010 15.0 mg/kg Weekly  
STARTED     3     3     4     3     2     3     3     5     17  
COMPLETED     0     0     0     0     0     0     0     0     0  
NOT COMPLETED     3     3     4     3     2     3     3     5     17  
Death                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Adverse Event                 0                 0                 1                 0                 0                 0                 1                 0                 0  
Global deterioration of health                 1                 0                 0                 0                 0                 0                 0                 0                 0  
Objective progression or relapse                 2                 3                 3                 2                 2                 3                 2                 5                 15  
Withdrawal by Subject                 0                 0                 0                 1                 0                 0                 0                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PF-03732010 0.5 mg/kg Biweekly PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 1.0 mg/kg Biweekly PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-3732010 2.0 mg/kg Biweekly PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 4.0 mg/kg Biweekly PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 8.0 mg/kg Biweekly PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 15.0 mg/kg Biweekly PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 4.0 mg/kg Weekly PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 8.0 mg/kg Weekly PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 15.0 mg/kg Weekly PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Total Total of all reporting groups

Baseline Measures
    PF-03732010 0.5 mg/kg Biweekly     PF-03732010 1.0 mg/kg Biweekly     PF-3732010 2.0 mg/kg Biweekly     PF-03732010 4.0 mg/kg Biweekly     PF-03732010 8.0 mg/kg Biweekly     PF-03732010 15.0 mg/kg Biweekly     PF-03732010 4.0 mg/kg Weekly     PF-03732010 8.0 mg/kg Weekly     PF-03732010 15.0 mg/kg Weekly     Total  
Number of Participants  
[units: participants]
  3     3     4     3     2     3     3     5     17     43  
Age, Customized  
[units: participants]
                   
18 to 44 years     0     1     0     1     0     1     0     1     1     5  
45 to 64 years     1     1     3     2     2     1     1     3     13     27  
Equal to or greater than 65 years     2     1     1     0     0     1     2     1     3     11  
Gender  
[units: participants]
                   
Female     1     2     1     1     1     1     1     2     7     17  
Male     2     1     3     2     1     2     2     3     10     26  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle ]

2.  Primary:   Recommended Phase-2 Dose (RP2D)   [ Time Frame: Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle ]

3.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]   [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal ]

4.  Secondary:   Time to Reach Maximum Observed Serum Concentration (Tmax)   [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal ]

5.  Secondary:   Minimum Observed Serum Trough Concentration (Cmin)   [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal ]

6.  Secondary:   Maximum Observed Serum Concentration (Cmax)   [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal ]

7.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)]   [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal ]

8.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)   [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal ]

9.  Secondary:   Clearance (CL)   [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal ]

10.  Secondary:   Apparent Volume of Distribution (Vd)   [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal ]

11.  Secondary:   Number of Participants With Objective Response of Complete Response or Partial Response   [ Time Frame: Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37 ]

12.  Other Pre-specified:   Human Anti-Human Antibody (HAHA) Levels   [ Time Frame: Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal ]

13.  Other Pre-specified:   Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET)   [ Time Frame: Baseline, cycle 3 and after 8 weeks ]

14.  Other Pre-specified:   Time to Disease Progression   [ Time Frame: Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37 ]

15.  Other Pre-specified:   Change From Baseline in Circulating Tumor Cells (CTC) Concentration in Blood   [ Time Frame: Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal ]

16.  Other Pre-specified:   Change From Baseline in Leucocyte Subtypes   [ Time Frame: Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal ]

17.  Other Pre-specified:   Change From Baseline in Cytokine Concentration   [ Time Frame: Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1 ]

18.  Other Pre-specified:   Change From Baseline in Tumor Proteins Related to P-cadherin Signaling and/or Tumor Proliferation or Apoptosis by Immunohistochemistry (IHC)   [ Time Frame: Baseline and cycle 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Results are not provided because development of the study drug was terminated, as neither anti-tumor activity nor pharmacodynamic modulation was observed.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00557505     History of Changes
Other Study ID Numbers: A9301001
Study First Received: November 12, 2007
Results First Received: January 10, 2012
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration