Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

• Sponsor: EVIVE Biotechnology (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02872103
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Arms: 2
• Duration (Months): 16.6
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief Summary

This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Neutropenia	Drug: F-627; Drug: Placebo	Phase 3

Detailed Description

This is a randomized, multi-center, single dose, double-blind, placebo controlled phase III study of the efficacy and safety of once-per-cycle of F-627 in women with stage II-IV breast cancer who are receiving myelotoxic TA chemotherapy treatment (Taxotere (docetaxel) + Adriamycin(doxorubicin)). F-627 is designed to treat neutropenia, an abnormally low number of neutrophils (a type of white blood cell) in the blood. Neutropenia is often seen in cancer patients receiving myelotoxic chemotherapy.

The primary objective of this study is to evaluate the efficacy and safety of single fixed dose of F-627 in breast cancer patients experiencing myelotoxic chemotherapy in comparison to placebo. F-627 or placebo is to be administered subcutaneously 24 hours after chemotherapy in each 21-day cycle of chemotherapy treatment (up to 4 cycles). Patients randomized to placebo arm will receive F-627 except in cycle 1. The primary endpoint will be the duration of grade 4 (severe) neutropenia - the number of days in which the patient has had an absolute neutrophil count (ANC < 0.5 x 10^9/L) observed in chemotherapy cycle 1.

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
• Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Dec 20, 2017
• Actual Study Completion Date: Dec 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: F-627 F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Drug: F-627; F-627 subcutaneous injection on Day 2 of TA chemotherapy cycles. TA chemotherapy treatments are part of standard-of-care and not the study
Placebo Comparator: Placebo Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.	Drug: F-627; F-627 subcutaneous injection on Day 2 of TA chemotherapy cycles. TA chemotherapy treatments are part of standard-of-care and not the study; Drug: Placebo; Placebo subcutaneous injection on Day 2 of the first TA chemotherapy cycle. TA chemotherapy treatments are part of standard-of-care and not the study.

Outcome Measures

Primary Outcome Measures

1. The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo [The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks]

   Subjects will be randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects will either receive 20mg fixed dose F-627 or Placebo. The subject's absolute neutrophil count (ANC) will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0x10^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered. The duration of grade 4 neutropenia (ANC <0.5x10^9/L) in this cycle is the primary efficacy endpoint.

Secondary Outcome Measures

1. The Duration in Days of Grade 4 (Severe) Neutropenia (ANC < 0.5 × 10^9/L) for Chemotherapy Cycles 2, 3, and 4, and Over All Cycles. [Over all 4 cycles, about 12 weeks]

   The duration of severe neutropenia will be measured for each patient during chemotherapy cycle 2-4 and over all cycles. Each chemotherapy is expected to last 21 days.

2. The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles. [4 chemotherapy cycles, about 12 weeks]

   The duration in days of mild, moderate and severe neutropenia will be recorded for 4 chemotherapy cycles. Grade 2 neutropenia is when a patient's ANC<1.5x10^9/L, Grade 3 neutropenia is when a patient's ANC<1.0x10^9/L, and Grade 4 neutropenia is when a patient's ANC <0.5x10^9/L.

3. Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles [4 chemotherapy cycles, about 12 weeks]

   Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of >38.0°C (100.4°F) sustained for >1 hour and ANC < 0.5 x 10^9/L

4. Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles. [4 chemotherapy cycles, about 12 weeks]

   The number of subjects with grade 2, 3 and 4 neutropenia will be recorded for all 4 chemotherapy cycles.

5. The Time in Days to ANC Recovery Post Nadir for Each Chemotherapy Cycle and Over All Cycles; Recovery Defined as an ANC ≥ 2.0 × 10^9/L After the Expected ANC Nadir. [4 chemotherapy cycles, about 12 weeks]

   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).

6. The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles. [4 chemotherapy cycles, about 12 weeks]

   The depth of ANC nadir for each cycle is the minimal ANC value (× 10^9/L ) for a patient in each chemotherapy cycle

7. Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. [4 chemotherapy cycles, about 12 weeks]

   The number of subjects with infections for each arm of the study will be recorded for each and all 4 chemotherapy cycles.

8. Number of Participants With Use of Antibiotics and Pain Medications [4 chemotherapy cycles, about 12 weeks]

   Antibiotics and pain medications use will be recorded for each chemotherapy cycle and overall cycles

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.

2. Females ≥ 18 years of age and < 75 years of age.

3. Diagnosed with Stage II-IV breast cancer.

4. Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).

5. ECOG Performance status of ≤ 2.

6. White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.

7. 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.

8. 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 is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.

Exclusion Criteria:

1. Subject is <18 or ≥ 75 years of age.

2. Disease progression has occurred while receiving a taxane regimen.

3. Subject has undergone radiation therapy within 4 weeks of enrollment.

4. Subject has undergone bone marrow or stem-cell transplantation.

5. Subject has a history of prior malignancy other than breast cancer that is NOT in remission.

6. Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e. lithium) within 6 weeks of the screening period are excluded.

7. Subject has had chemotherapy within 365 days of screening.

8. Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.

9. History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.

10. Unwillingness to participate in the study.

11. 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.

12. Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.

13. Any condition, which can cause splenomegaly.

14. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.

15. ALT, AST, alkaline phosphatase, total bilirubin ≥ 2.5 upper limit of normal.

16. Subject 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.

17. Women who are pregnant or breast-feeding.

18. Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.

19. Subject 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.

20. Subjects with Sickle Cell disease

21. Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• EVIVE Biotechnology

Investigators

• Study Director: Kevin F Dreyer, EVIVE Biotechnology

Study Documents (Full-Text)

• Study Protocol - May 7, 2017
• Statistical Analysis Plan - Dec 14, 2017

More Information

Publications

None provided.

• Responsible Party: EVIVE Biotechnology
• ClinicalTrials.gov Identifier: NCT02872103
• Other Study ID Numbers: GC-627-04
• First Posted: Aug 19, 2016
• Last Update Posted: May 5, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Neoplasms; Neutropenia

Study Results

Participant Flow

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Period Title: Cycle 1
STARTED	83	39
COMPLETED	83	38
NOT COMPLETED	0	1
Period Title: Cycle 1
STARTED	83	38
COMPLETED	81	37
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	F-627	Placebo	Total
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.	Total of all reporting groups
Overall Participants	83	39	122
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.8 (9.25)	51.5 (9.00)	51.0 (9.14)
Sex: Female, Male (Count of Participants)
Female	83 100%	39 100%	122 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.2%	1 2.6%	2 1.6%
Not Hispanic or Latino	82 98.8%	38 97.4%	120 98.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 1.2%	0 0%	1 0.8%
White	82 98.8%	39 100%	121 99.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	1 1.2%	0 0%	1 0.8%
Ukraine	46 55.4%	22 56.4%	68 55.7%
Russia	32 38.6%	16 41%	48 39.3%
Hungary	4 4.8%	1 2.6%	5 4.1%
Reproductive Status (Count of Participants)
Childbearing potential	37 44.6%	15 38.5%	52 42.6%
Non-childbearing potential - Post-menopausal	42 50.6%	23 59%	65 53.3%
Non-childbearing potential - Surgically sterile	4 4.8%	1 2.6%	5 4.1%
BMI (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.2 (5.36)	27.4 (6.22)	26.6 (5.65)
Baseline ECOG (Count of Participants)
Grade 0	46 55.4%	27 69.2%	73 59.8%
Grade 1	37 44.6%	12 30.8%	49 40.2%
Cancer Stage at Screening (Count of Participants)
Stage II	43 51.8%	21 53.8%	64 52.5%
Stage III	22 26.5%	12 30.8%	34 27.9%
Stage IV	18 21.7%	6 15.4%	24 19.7%
Days from Diagnosis (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	224.5 (572.21)	445.9 (1337.99)	294.6 (888.93)

Outcome Measures

1. Primary Outcome

Title	The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo
Description	Subjects will be randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects will either receive 20mg fixed dose F-627 or Placebo. The subject's absolute neutrophil count (ANC) will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0x10^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered. The duration of grade 4 neutropenia (ANC <0.5x10^9/L) in this cycle is the primary efficacy endpoint.
Time Frame	The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Measure Participants	83	39
Mean (Standard Deviation) [days]	1.3 (1.17)	3.9 (1.35)

2. Secondary Outcome

Title	The Duration in Days of Grade 4 (Severe) Neutropenia (ANC < 0.5 × 10^9/L) for Chemotherapy Cycles 2, 3, and 4, and Over All Cycles.
Description	The duration of severe neutropenia will be measured for each patient during chemotherapy cycle 2-4 and over all cycles. Each chemotherapy is expected to last 21 days.
Time Frame	Over all 4 cycles, about 12 weeks

Outcome Measure Data

Analysis Population Description

Missing ANC data. No multiple imputation

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Measure Participants	83	39
Cycle 2	0.3 (0.76)	0.8 (1.20)
Cycle 3	0.3 (0.84)	0.5 (1.19)
Cycle 4	0.2 (0.62)	0.7 (1.39)
All cycles	0.5 (0.62)	1.4 (1.32)

3. Secondary Outcome

Title	The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles.
Description	The duration in days of mild, moderate and severe neutropenia will be recorded for 4 chemotherapy cycles. Grade 2 neutropenia is when a patient's ANC<1.5x10^9/L, Grade 3 neutropenia is when a patient's ANC<1.0x10^9/L, and Grade 4 neutropenia is when a patient's ANC <0.5x10^9/L.
Time Frame	4 chemotherapy cycles, about 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Measure Participants	83	39
Grade 4	0.5 (0.62)	1.4 (1.32)
Grade 3	1.2 (1.08)	1.9 (1.46)
Grade 2	1.8 (1.24)	2.7 (1.71)

4. Secondary Outcome

Title	Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles
Description	Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of >38.0°C (100.4°F) sustained for >1 hour and ANC < 0.5 x 10^9/L
Time Frame	4 chemotherapy cycles, about 12 weeks

Outcome Measure Data

Analysis Population Description

3 subjects terminated early.

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Measure Participants	83	39
Subjects with FN	4 4.8%	10 25.6%
Subject without FN	79 95.2%	29 74.4%
Subjects with FN	0 0%	1 2.6%
Subject without FN	83 100%	37 94.9%
Subjects with FN	0 0%	0 0%
Subject without FN	82 98.8%	37 94.9%
Subjects with FN	0 0%	0 0%
Subject without FN	82 98.8%	37 94.9%
Subjects with FN	4 4.8%	11 28.2%
Subject without FN	79 95.2%	28 71.8%

5. Secondary Outcome

Title	Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles.
Description	The number of subjects with grade 2, 3 and 4 neutropenia will be recorded for all 4 chemotherapy cycles.
Time Frame	4 chemotherapy cycles, about 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Measure Participants	83	39
yes	58 69.9%	37 94.9%
no	25 30.1%	2 5.1%
yes	71 85.5%	37 94.9%
no	12 14.5%	2 5.1%
yes	77 92.8%	37 94.9%
no	6 7.2%	2 5.1%

6. Secondary Outcome

Title	The Time in Days to ANC Recovery Post Nadir for Each Chemotherapy Cycle and Over All Cycles; Recovery Defined as an ANC ≥ 2.0 × 10^9/L After the Expected ANC Nadir.
Description	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).
Time Frame	4 chemotherapy cycles, about 12 weeks

Outcome Measure Data

Analysis Population Description

3 Subjects terminated early (1 in F-627 arm, 2 in the placebo arm). In addition, 1 subject in placebo arm reached her Nadir(1.81) at Day 7 but the rest of ANC values are missing. Because the recovery information is not available, this subject was removed from the Time to ANC recovery analysis.

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Measure Participants	83	39
Cycle 1	2.1 (1.08)	4.0 (2.07)
Cycle 2	1.6 (1.35)	2.0 (1.37)
Cycle 3	1.6 (1.34)	1.7 (1.79)
Cycle 4	1.9 (1.39)	1.5 (1.73)
All cycles	1.8 (0.94)	2.4 (1.20)

7. Secondary Outcome

Title	The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles.
Description	The depth of ANC nadir for each cycle is the minimal ANC value (× 10^9/L ) for a patient in each chemotherapy cycle
Time Frame	4 chemotherapy cycles, about 12 weeks

Outcome Measure Data

Analysis Population Description

3 subjects terminated early.

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Measure Participants	83	39
Cycle 1	0.7 (1.16)	0.2 (0.57)
Cycle 2	2.0 (1.71)	1.6 (1.71)
Cycle 3	1.7 (1.58)	1.8 (1.63)
Cycle 4	1.7 (1.45)	2.3 (2.01)
All cycles	1.5 (1.20)	1.4 (1.23)

8. Secondary Outcome

Title	Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles.
Description	The number of subjects with infections for each arm of the study will be recorded for each and all 4 chemotherapy cycles.
Time Frame	4 chemotherapy cycles, about 12 weeks

Outcome Measure Data

Analysis Population Description

Some subjects terminated earlier

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Measure Participants	83	39
Subjects with infection	2 2.4%	3 7.7%
Subjects without infection	81 97.6%	36 92.3%
Subjects with infection	1 1.2%	2 5.1%
Subjects without infection	82 98.8%	36 92.3%
Subjects with infection	5 6%	3 7.7%
Subjects without infection	77 92.8%	34 87.2%
Subjects with infection	1 1.2%	0 0%
Subjects without infection	81 97.6%	37 94.9%
Subjects with infection	9 10.8%	8 20.5%
Subjects without infection	74 89.2%	31 79.5%

9. Secondary Outcome

Title	Number of Participants With Use of Antibiotics and Pain Medications
Description	Antibiotics and pain medications use will be recorded for each chemotherapy cycle and overall cycles
Time Frame	4 chemotherapy cycles, about 12 weeks

Outcome Measure Data

Analysis Population Description

3 subjects terminated early

Arm/Group Title	F-627	Placebo
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Measure Participants	83	39
antibiotic and pain medications use	9 10.8%	13 33.3%
no antibiotic and pain medications use	74 89.2%	26 66.7%
antibiotic and pain medications use	3 3.6%	2 5.1%
no antibiotic and pain medications use	80 96.4%	36 92.3%
antibiotic and pain medications use	2 2.4%	1 2.6%
no antibiotic and pain medications use	80 96.4%	36 92.3%
antibiotic and pain medications use	1 1.2%	0 0%
no antibiotic and pain medications use	81 97.6%	37 94.9%
antibiotic and pain medications use	13 15.7%	15 38.5%
no antibiotic and pain medications use	70 84.3%	24 61.5%

Adverse Events

Time Frame	AEs and SAEs were collected from the time of randomization until 28 days after completion of the trial (a total of 16 weeks) or 28 days after premature withdrawal of a subject from the trial.
Arm/Group Title	Cycle 1 F-627		Cycle 1 Placebo		All 4 Cycles F-627		Cycle 1 Placebo and Cycle 2-4 F-627
Arm/Group Description	F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.		Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle 1		F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.		Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
All Cause Mortality
	Cycle 1 F-627		Cycle 1 Placebo		All 4 Cycles F-627		Cycle 1 Placebo and Cycle 2-4 F-627
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/39 (0%)		0/83 (0%)		0/39 (0%)
Serious Adverse Events
	Cycle 1 F-627		Cycle 1 Placebo		All 4 Cycles F-627		Cycle 1 Placebo and Cycle 2-4 F-627
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/83 (4.8%)		10/39 (25.6%)		4/83 (4.8%)		11/39 (28.2%)
Blood and lymphatic system disorders
Febrile Neutropenia	3/83 (3.6%)		10/39 (25.6%)		3/83 (3.6%)		11/39 (28.2%)
Gastrointestinal disorders
Diarrhea	0/83 (0%)		1/39 (2.6%)		0/83 (0%)		1/39 (2.6%)
Infections and infestations
Pneumonia	0/83 (0%)		0/39 (0%)		0/83 (0%)		1/39 (2.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage	1/83 (1.2%)		0/39 (0%)		1/83 (1.2%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Cycle 1 F-627		Cycle 1 Placebo		All 4 Cycles F-627		Cycle 1 Placebo and Cycle 2-4 F-627
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/83 (20.5%)		5/39 (12.8%)		26/83 (31.3%)		9/39 (23.1%)
Gastrointestinal disorders
Nausea	6/83 (7.2%)		1/39 (2.6%)		8/83 (9.6%)		3/39 (7.7%)
Diarrhea	4/83 (4.8%)		1/39 (2.6%)		5/83 (6%)		2/39 (5.1%)
Stomatitis	3/83 (3.6%)		2/39 (5.1%)		4/83 (4.8%)		2/39 (5.1%)
General disorders
Fatigue	3/83 (3.6%)		2/39 (5.1%)		4/83 (4.8%)		4/39 (10.3%)
Musculoskeletal and connective tissue disorders
Bone pain	4/83 (4.8%)		0/39 (0%)		5/83 (6%)		1/39 (2.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.