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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Generon (Shanghai) Corporation Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Generon (Shanghai) Corporation Ltd.
ClinicalTrials.gov Identifier:
NCT01648322
First received: April 27, 2012
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

This is a randomized open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage II-III breast cancer receiving chemotherapy treatment.


Condition Intervention Phase
Breast Cancer
Drug: F-627
Drug: Neulasta® (pegfilgrastim)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Multi-Centre, Open-Label, Active-Controlled, Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Resource links provided by NLM:


Further study details as provided by Generon (Shanghai) Corporation Ltd.:

Primary Outcome Measures:
  • The efficacy and safety of various single cycle doses of F-627 to measure the duration of moderate neutropenia post Chemotherapy administration as compared with the standard dosing of Neulasta [ Time Frame: The first of 4, 21 Day Chemotherapy Cycles ] [ Designated as safety issue: Yes ]
    After randomization, The subject's ANC value will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0 x 10^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered.


Secondary Outcome Measures:
  • Duration 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. ] [ Designated as safety issue: No ]
    The duration of Grade 3 & Grade 4 neutropenia will be measured for each patient during each chemotherapy cycle administered (up to 4 cycles, each cycle is expected to last 21 days). The duration of Grade 3 & 4 neutropenia is expected to be between days 4-10 (on average) during each chemotherapy cycle. Grade 3 neutropenia is when a patient's ANC < 1.0 × 10^9/L, Grade 4 neutropenia is when a patient's ANC < .5 × 10^9/L

  • The incidence rate of febrile neutropenia [ Time Frame: Measured for each of the 4, 21 day chemotherapy cycles. ] [ Designated as safety issue: Yes ]
    The incidence rate of febrile neutropenia for each arm of the study will be recorded for 4 chemotherapy cycles. Each cycle is expected to last 21 Days.

  • The duration of total grade 2 neutropenia [ Time Frame: Measured for each of the 4, 21 day chemotherapy cycles. ] [ Designated as safety issue: No ]
    After randomization, the duration of time for which grade 2 neutropenia (ANC < 1.5 × 109/L) occurs for each 21 day chemotherapy cycle will be recorded.

  • The time to ANC recovery post nadir [ Time Frame: Measured for each of the 4, 21 day chemotherapy cycles. ] [ Designated as safety issue: No ]
    The time to ANC recovery post nadir for each patient, for each of their chemotherapy cycles will be recorded; recovery for this protocol is defined as achieving an ANC ≥ 2.0 × 10^9/L after the expected ANC nadir (expected nadir is typically 4-6 days post chemotherapy administration). Each chemotherapy cycle is expected to last 21 days.


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 80 µg/kg/dose of F-627 Drug: F-627
subcutaneous injection given 1 per chemotherapy.
Experimental: 240 µg/kg/dose of F-627 Drug: F-627
subcutaneous injection given 1 per chemotherapy.
Experimental: 320 µg/kg/dose of F-627 Drug: F-627
subcutaneous injection given 1 per chemotherapy.
Active Comparator: Neulasta® (pegfilgrastim) Drug: Neulasta® (pegfilgrastim)
Single dose injection given once per chemotherapy cycle.

Detailed Description:

This is a randomized, multi-center, dose finding, open label, positive controlled Phase II study of the efficacy and safety of once-per-cycle of F-627 compared with Neulasta® (pegfilgrastim) in women with breast cancer who are receiving myelotoxic TC chemotherapy (Taxotere (docetaxel) + cyclophosphamide).

The primary objective of this study is to evaluate the efficacy and safety of various single cycle doses of F-627 as compared with the standard dosing of Neulasta® (pegfilgrastim) in breast cancer patients experiencing myelotoxic chemotherapy. Myelotoxicity in this study will be defined by the duration of moderate neutropenia; the number of days in which the patient has had an absolute neutrophil count (ANC) < 1.0 × 10^9/L during the first cycle of their chemotherapy treatment (each chemotherapy cycle is expected to last 21 days). This, by definition, includes grade 3 (moderate) and grade 4 (severe) neutropenia. Doses of F-627 to be tested are 80 µg/kg/dose, 240 µg/kg/dose, and 320 µg/kg/dose.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Show evidence of a signed (personally or by a legally acceptable representative) and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
  • Females ≥ 18 years of age.
  • Diagnosed with Stage II-III breast cancer.
  • Subject is scheduled to undergo 4 cycles of TC chemotherapy (Taxotere and cyclophosphamide, 75 and 600 mg/m2, respectively).
  • ECOG Performance status of ≤ 2.
  • White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
  • Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
  • All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide are also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.

Exclusion Criteria:

  • Subject is <18 or ≥ 75 years of age.
  • Disease progression has occurred while receiving a taxane regimen.
  • Subject has undergone radiation therapy within 4 weeks of enrollment.
  • Subject has undergone bone marrow or stem-cell transplantation.
  • Subject has a history of prior malignancy other than breast cancer.
  • Subjects that have used G-CSF within 6 weeks of the screening period are also excluded
  • Subject has had chemotherapy within 365 days of screening
  • Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.
  • History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
  • Unwillingness to participate in the study.
  • Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
  • Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.
  • Any condition, which can cause splenomegaly.
  • Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
  • ALT, AST, alkaline phosphatase > 2.5 upper limit of normal.
  • Patients with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
  • Women who are pregnant or breast-feeding.
  • Patients known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
  • Patients with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
  • Subjects with Sickle Cell disease
  • Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.
  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: NCT01648322

Contacts
Contact: Gerald McPherson 512 301-7615 gmcpherson@clincialresearchmgt.com
Contact: Diane Bedor 413 821-0022 dbedor@clinicalresearchmgt.com

Locations
United States, Indiana
Community Hospital of Anderson Recruiting
Anderson, Indiana, United States
Contact: Sara Howard, R.N.         
Sponsors and Collaborators
Generon (Shanghai) Corporation Ltd.
  More Information

No publications provided

Responsible Party: Generon (Shanghai) Corporation Ltd.
ClinicalTrials.gov Identifier: NCT01648322     History of Changes
Other Study ID Numbers: GC-627-02
Study First Received: April 27, 2012
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Generon (Shanghai) Corporation Ltd.:
Breast Cancer
Taxotere Chemotherapy
Neulasta
efficacy and safety
single cycle doses of F-627
pegfilgrastim

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014