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

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ClinicalTrials.gov Identifier: NCT00557505
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : March 26, 2012
Last Update Posted : March 26, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neoplasms
Intervention: Drug: PF-03732010

  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

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 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 1

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

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

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 ]
  Show Outcome Measure 17

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 ]
  Show Outcome Measure 18


  Serious Adverse Events


  Other Adverse Events


  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

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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00557505     History of Changes
Other Study ID Numbers: A9301001
First Submitted: November 12, 2007
First Posted: November 14, 2007
Results First Submitted: January 10, 2012
Results First Posted: March 26, 2012
Last Update Posted: March 26, 2012