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Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

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ClinicalTrials.gov Identifier: NCT01648322
Recruitment Status : Completed
First Posted : July 24, 2012
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Generon (Shanghai) Corporation Ltd.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer
Neutropenia
Interventions: Drug: F-627
Drug: Neulasta® (pegfilgrastim)

  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
80 µg/kg/Dose of F-627

This dose of F-627 given only to subjects that are to have TC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

240 µg/kg/Dose of F-627

This dose of F-627 given to subjects receiving TC or TAC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

320 µg/kg/Dose of F-627

This dose of F-627 given to subjects receiving TC or TAC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

Neulasta® (Pegfilgrastim)

Given to subjects receiving TC or TAC chemotherapy.

Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle.


Participant Flow:   Overall Study
    80 µg/kg/Dose of F-627   240 µg/kg/Dose of F-627   320 µg/kg/Dose of F-627   Neulasta® (Pegfilgrastim)
STARTED   35   67   65   65 
COMPLETED   33   62   60   61 
NOT COMPLETED   2   5   5   4 



  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
80 µg/kg/Dose of F-627

This dose of F-627 given only to subjects that are to have TC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

240 µg/kg/Dose of F-627

This dose of F-627 given to subjects receiving TC or TAC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

320 µg/kg/Dose of F-627

This dose of F-627 given to subjects receiving TC or TAC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

Neulasta® (Pegfilgrastim)

Given to subjects receiving TC or TAC chemotherapy.

Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle.

Total Total of all reporting groups

Baseline Measures
   80 µg/kg/Dose of F-627   240 µg/kg/Dose of F-627   320 µg/kg/Dose of F-627   Neulasta® (Pegfilgrastim)   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   67   65   65   232 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.7  (10.3)   47.9  (10.1)   48.9  (10.3)   48.2  (10.9)   48.4  (10.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      35 100.0%      67 100.0%      65 100.0%      65 100.0%      232 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
weight 
[Units: Kg]
Mean (Standard Deviation)
 73.28  (17.12)   70.89  (14.44)   70.22  (12.94)   71.28  (14.09)   71.18  (14.32) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 164.88  (5.66)   163.58  (8.15)   162.90  (5.66)   162.80  (6.99)   163.37  (6.83) 
ECOG status [1] 
[Units: Participants]
Count of Participants
         
Grade 0   25   40   42   41   148 
Grade 1   10   27   23   24   84 
Grade 2   0   0   0   0   0 
[1]

The ECOG Scale of Performance Status describes a patient’s level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.).

GRADE 0. Fully active

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all self care but unable to carry out any work activities

A subject's ECOG grade is determined by the study doctor based on the established criteria listed above.

Grade 0 is best. Grade 2 is worse than Grade 1.

Cancer Stage at screen 
[Units: Participants]
         
 1   12   12   9   34 
II   25   28   32   31   116 
III   9   23   18   23   73 
IV   0   4   3   2   9 


  Outcome Measures

1.  Primary:   Duration of Moderate Neurtopenia Post First Chemotherapy Administration   [ Time Frame: The first of 4, 21 Day Chemotherapy Cycles ]

2.  Secondary:   Duration in Days of Grade 3 and Grade 4 Neutropenia for Each of 4 Chemotherapy Cycles.   [ Time Frame: Measured for each of the 4, 21 day chemotherapy cycles. ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  

3.  Secondary:   The Incidence Rate of Febrile Neutropenia   [ Time Frame: Measured for each of the 4, 21 day chemotherapy cycles. ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  

4.  Secondary:   The Duration in Days of Total Grade 2 Neutropenia   [ Time Frame: Measured for each of the 4, 21 day chemotherapy cycles. ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  

5.  Secondary:   The Time to ANC Recovery Post Nadir   [ Time Frame: Measured for each of the 4, 21 day chemotherapy cycles. ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  

6.  Secondary:   The Incidence Rates of Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles   [ Time Frame: Measured for each of the 4, 21 day chemotherapy cycles. ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  

7.  Secondary:   The Depth of the ANC Nadir for All Chemotherapy Cycles   [ Time Frame: Measured for each of the 4, 21 day chemotherapy cycles ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  


  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
No text entered.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Generon (shanghai) corporation
phone: 8621-61760866
e-mail: tangt@generonbiomed.com



Responsible Party: Generon (Shanghai) Corporation Ltd.
ClinicalTrials.gov Identifier: NCT01648322     History of Changes
Other Study ID Numbers: GC-627-02
First Submitted: April 27, 2012
First Posted: July 24, 2012
Results First Submitted: August 26, 2016
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018