Trial Outcomes & Findings for Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (NCT NCT02872103)

NCT ID: NCT02872103

Last Updated: 2021-05-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 122 participants
• Primary outcome timeframe: The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks
• Results posted on: 2021-05-05

Participant Flow

Participant milestones

Measure	F-627 F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	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.
Cycle 1 STARTED	83	39
Cycle 1 COMPLETED	83	38
Cycle 1 NOT COMPLETED	0	1
Cycle 2-4 STARTED	83	38
Cycle 2-4 COMPLETED	81	37
Cycle 2-4 NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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 n=122 Participants Total of all reporting groups
Age, Continuous	50.8 years STANDARD_DEVIATION 9.25 • n=93 Participants	51.5 years STANDARD_DEVIATION 9.00 • n=4 Participants	51.0 years STANDARD_DEVIATION 9.14 • n=27 Participants
Sex: Female, Male Female	83 Participants n=93 Participants	39 Participants n=4 Participants	122 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=93 Participants	38 Participants n=4 Participants	120 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	82 Participants n=93 Participants	39 Participants n=4 Participants	121 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment Ukraine	46 participants n=93 Participants	22 participants n=4 Participants	68 participants n=27 Participants
Region of Enrollment Russia	32 participants n=93 Participants	16 participants n=4 Participants	48 participants n=27 Participants
Region of Enrollment Hungary	4 participants n=93 Participants	1 participants n=4 Participants	5 participants n=27 Participants
Reproductive Status Childbearing potential	37 Participants n=93 Participants	15 Participants n=4 Participants	52 Participants n=27 Participants
Reproductive Status Non-childbearing potential - Post-menopausal	42 Participants n=93 Participants	23 Participants n=4 Participants	65 Participants n=27 Participants
Reproductive Status Non-childbearing potential - Surgically sterile	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
BMI (kg/m^2)	26.2 kg/m^2 STANDARD_DEVIATION 5.36 • n=93 Participants	27.4 kg/m^2 STANDARD_DEVIATION 6.22 • n=4 Participants	26.6 kg/m^2 STANDARD_DEVIATION 5.65 • n=27 Participants
Baseline ECOG Grade 0	46 Participants n=93 Participants	27 Participants n=4 Participants	73 Participants n=27 Participants
Baseline ECOG Grade 1	37 Participants n=93 Participants	12 Participants n=4 Participants	49 Participants n=27 Participants
Cancer Stage at Screening Stage II	43 Participants n=93 Participants	21 Participants n=4 Participants	64 Participants n=27 Participants
Cancer Stage at Screening Stage III	22 Participants n=93 Participants	12 Participants n=4 Participants	34 Participants n=27 Participants
Cancer Stage at Screening Stage IV	18 Participants n=93 Participants	6 Participants n=4 Participants	24 Participants n=27 Participants
Days from Diagnosis	224.5 days STANDARD_DEVIATION 572.21 • n=93 Participants	445.9 days STANDARD_DEVIATION 1337.99 • n=4 Participants	294.6 days STANDARD_DEVIATION 888.93 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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.
The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo	1.3 days Standard Deviation 1.17	3.9 days Standard Deviation 1.35

SECONDARY outcome

Timeframe: Over all 4 cycles, about 12 weeks

Population: Missing ANC data. No multiple imputation

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.

Outcome measures

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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.
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. Cycle 3	0.3 days Standard Deviation 0.84	0.5 days Standard Deviation 1.19
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. Cycle 4	0.2 days Standard Deviation 0.62	0.7 days Standard Deviation 1.39
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. All cycles	0.5 days Standard Deviation 0.62	1.4 days Standard Deviation 1.32
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. Cycle 2	0.3 days Standard Deviation 0.76	0.8 days Standard Deviation 1.20

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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.
The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles. Grade 4	0.5 days Standard Deviation 0.62	1.4 days Standard Deviation 1.32
The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles. Grade 3	1.2 days Standard Deviation 1.08	1.9 days Standard Deviation 1.46
The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles. Grade 2	1.8 days Standard Deviation 1.24	2.7 days Standard Deviation 1.71

SECONDARY outcome

Timeframe: 4 chemotherapy cycles, about 12 weeks

Population: 3 subjects terminated early.

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

Outcome measures

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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.
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles Cycle 1 · Subjects with FN	4 Participants	10 Participants
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles Cycle 1 · Subject without FN	79 Participants	29 Participants
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles Cycle 2 · Subjects with FN	0 Participants	1 Participants
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles Cycle 2 · Subject without FN	83 Participants	37 Participants
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles Cycle 3 · Subjects with FN	0 Participants	0 Participants
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles Cycle 3 · Subject without FN	82 Participants	37 Participants
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles Cycle 4 · Subjects with FN	0 Participants	0 Participants
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles Cycle 4 · Subject without FN	82 Participants	37 Participants
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles All cycles · Subjects with FN	4 Participants	11 Participants
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles All cycles · Subject without FN	79 Participants	28 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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.
Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles. Grade 4 Neutropenia · yes	58 Participants	37 Participants
Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles. Grade 4 Neutropenia · no	25 Participants	2 Participants
Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles. Grade 3 Neutropenia · yes	71 Participants	37 Participants
Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles. Grade 3 Neutropenia · no	12 Participants	2 Participants
Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles. Grade 2 Neutropenia · yes	77 Participants	37 Participants
Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles. Grade 2 Neutropenia · no	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 chemotherapy cycles, about 12 weeks

Population: 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.

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).

Outcome measures

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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.
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. Cycle 3	1.6 days Standard Deviation 1.34	1.7 days Standard Deviation 1.79
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. Cycle 4	1.9 days Standard Deviation 1.39	1.5 days Standard Deviation 1.73
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. Cycle 1	2.1 days Standard Deviation 1.08	4.0 days Standard Deviation 2.07
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. Cycle 2	1.6 days Standard Deviation 1.35	2.0 days Standard Deviation 1.37
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. All cycles	1.8 days Standard Deviation 0.94	2.4 days Standard Deviation 1.20

SECONDARY outcome

Timeframe: 4 chemotherapy cycles, about 12 weeks

Population: 3 subjects terminated early.

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

Outcome measures

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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.
The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles. Cycle 3	1.7 cells/10^9/L Standard Deviation 1.58	1.8 cells/10^9/L Standard Deviation 1.63
The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles. Cycle 4	1.7 cells/10^9/L Standard Deviation 1.45	2.3 cells/10^9/L Standard Deviation 2.01
The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles. Cycle 1	0.7 cells/10^9/L Standard Deviation 1.16	0.2 cells/10^9/L Standard Deviation 0.57
The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles. Cycle 2	2.0 cells/10^9/L Standard Deviation 1.71	1.6 cells/10^9/L Standard Deviation 1.71
The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles. All cycles	1.5 cells/10^9/L Standard Deviation 1.20	1.4 cells/10^9/L Standard Deviation 1.23

SECONDARY outcome

Timeframe: 4 chemotherapy cycles, about 12 weeks

Population: Some subjects terminated earlier

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

Outcome measures

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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.
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. Cycle 1 · Subjects with infection	2 Participants	3 Participants
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. Cycle 1 · Subjects without infection	81 Participants	36 Participants
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. Cycle 2 · Subjects with infection	1 Participants	2 Participants
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. Cycle 2 · Subjects without infection	82 Participants	36 Participants
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. Cycle 3 · Subjects with infection	5 Participants	3 Participants
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. Cycle 3 · Subjects without infection	77 Participants	34 Participants
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. Cycle 4 · Subjects with infection	1 Participants	0 Participants
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. Cycle 4 · Subjects without infection	81 Participants	37 Participants
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. All cycles · Subjects with infection	9 Participants	8 Participants
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles. All cycles · Subjects without infection	74 Participants	31 Participants

SECONDARY outcome

Timeframe: 4 chemotherapy cycles, about 12 weeks

Population: 3 subjects terminated early

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

Outcome measures

Measure	F-627 n=83 Participants F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Placebo n=39 Participants 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.
Number of Participants With Use of Antibiotics and Pain Medications Cycle 2 · antibiotic and pain medications use	3 Participants	2 Participants
Number of Participants With Use of Antibiotics and Pain Medications Cycle 2 · no antibiotic and pain medications use	80 Participants	36 Participants
Number of Participants With Use of Antibiotics and Pain Medications Cycle 3 · antibiotic and pain medications use	2 Participants	1 Participants
Number of Participants With Use of Antibiotics and Pain Medications Cycle 3 · no antibiotic and pain medications use	80 Participants	36 Participants
Number of Participants With Use of Antibiotics and Pain Medications All cycles · antibiotic and pain medications use	13 Participants	15 Participants
Number of Participants With Use of Antibiotics and Pain Medications All cycles · no antibiotic and pain medications use	70 Participants	24 Participants
Number of Participants With Use of Antibiotics and Pain Medications Cycle 1 · antibiotic and pain medications use	9 Participants	13 Participants
Number of Participants With Use of Antibiotics and Pain Medications Cycle 1 · no antibiotic and pain medications use	74 Participants	26 Participants
Number of Participants With Use of Antibiotics and Pain Medications Cycle 4 · antibiotic and pain medications use	1 Participants	0 Participants
Number of Participants With Use of Antibiotics and Pain Medications Cycle 4 · no antibiotic and pain medications use	81 Participants	37 Participants

Adverse Events

Cycle 1 F-627

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Cycle 1 Placebo

Serious events: 10 serious events

Other events: 5 other events

Deaths: 0 deaths

All 4 Cycles F-627

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Cycle 1 Placebo and Cycle 2-4 F-627

Serious events: 11 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cycle 1 F-627 n=83 participants at risk F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Cycle 1 Placebo n=39 participants at risk Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle 1	All 4 Cycles F-627 n=83 participants at risk F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Cycle 1 Placebo and Cycle 2-4 F-627 n=39 participants at risk 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.
Blood and lymphatic system disorders Febrile Neutropenia	3.6% 3/83 • 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.	25.6% 10/39 • 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.	3.6% 3/83 • 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.	28.2% 11/39 • 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.
Gastrointestinal disorders Diarrhea	0.00% 0/83 • 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.	2.6% 1/39 • 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.	0.00% 0/83 • 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.	2.6% 1/39 • 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.
Infections and infestations Pneumonia	0.00% 0/83 • 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.	0.00% 0/39 • 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.	0.00% 0/83 • 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.	2.6% 1/39 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor hemorrhage	1.2% 1/83 • 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.	0.00% 0/39 • 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.	1.2% 1/83 • 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.	0.00% 0/39 • 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.

Other adverse events

Measure	Cycle 1 F-627 n=83 participants at risk F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Cycle 1 Placebo n=39 participants at risk Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle 1	All 4 Cycles F-627 n=83 participants at risk F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.	Cycle 1 Placebo and Cycle 2-4 F-627 n=39 participants at risk 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.
Gastrointestinal disorders Nausea	7.2% 6/83 • 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.	2.6% 1/39 • 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.	9.6% 8/83 • 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.	7.7% 3/39 • 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.
Gastrointestinal disorders Diarrhea	4.8% 4/83 • 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.	2.6% 1/39 • 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.	6.0% 5/83 • 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.	5.1% 2/39 • 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.
Gastrointestinal disorders Stomatitis	3.6% 3/83 • 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.	5.1% 2/39 • 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.	4.8% 4/83 • 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.	5.1% 2/39 • 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.
Musculoskeletal and connective tissue disorders Bone pain	4.8% 4/83 • 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.	0.00% 0/39 • 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.	6.0% 5/83 • 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.	2.6% 1/39 • 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.
General disorders Fatigue	3.6% 3/83 • 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.	5.1% 2/39 • 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.	4.8% 4/83 • 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.	10.3% 4/39 • 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.

Additional Information

Jianmin Chen

Generon

Phone: 7327100262

Email: jianmin_chen@generonbiomed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place