A Study Of The Safety And Effects Of One Or More Doses Of... | NCT02650193

ID	Type	Description	Link
C1221002	Other Identifier	Alias Study Number
2015-002057-35	EudraCT Number

Name	Class
Hospira, now a wholly owned subsidiary of Pfizer	INDUSTRY

Description Module

Detailed Description

This is an open-label, sequential enrollment study characterizing the pharmacodynamic (PD), pharmacokinetic (PK) and safety of HSP-130 in subjects with non-metastatic breast cancer who have not previously received chemotherapy at any point prior to enrollment in this study (ZIN-130-1504).

The purpose of this study is to evaluate the effects and safety of single and multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will determine the dose to move forward for future clinical trials.

There are two aspects of the study. In the initial part of the study, 6 subjects will be sequentially enrolled to receive HSP-130 treatment (3 mg , or 6 mg by subcutaneous injection) during the period between biopsy and definitive surgery. This will determine whether 3 mg and 6 mg have similar or different effects on the PD variables (absolute neutrophil counts and CD34+ cell counts). This part of the study is referred to as Cycle 0 since study subjects will receive no chemotherapy while receiving HSP-130 until the effect of HSP-130 on the PD variables is known. A total of 12 subjects may be enrolled in Cycle 0.

The objective of Cycle 1-4 is to determine the dose to be taken forward to Phase 3 clinical trials. Cycles 1-4 subjects will receive HSP-130 after their definitive breast surgery at the time they receive TAC chemotherapy (docetaxel, doxorubicin, and cyclophosphamide). Subjects will receive up to 4 cycles of every 3 week TAC chemotherapy with HSP-130 given on Day 2 of the chemotherapy regimen.

If the 3 mg dose is found to be inferior (potentially subtherapeutic) to the 6 mg dose in Cycle 0, only the 6 mg dose will be studied in Cycles 1-4 (n=12), when subjects receive concomitant chemotherapy.
If the 3 mg dose is found to be comparable to the PD results obtained in Cycle 0 with 6 mg, the 3 mg dose (n=12) will also be studied in women receiving TAC chemotherapy.

Data from the HSP-130 6 mg regimen (plus 3 mg, as appropriate) will be analysed, discussed with the FDA and determination if a dose greater than 6 mg is appropriate to study (e.g., 12 mg). If all three doses are studied, a total enrollment of up to 36 subjects is projected for Cycles 1-4.

Label	Type	Description	Intervention Names
HSP-130	Experimental	Cycle 0: Regimen A: HSP 130, 3 mg, single SC injection in the deltoid region (n = 6) Regimen B: HSP 130, 6 mg, single SC injection in the deltoid region (n = 6) Cycles 1-4: Regimen B (n = 12): HSP 130, 6 mg, single SC injection in the deltoid region, at least 24 hours after administration of chemotherapy in Cycle 1, Cycle 2, Cycle 3, and Cycle 4. Potential Regimen A (n = 12): 3 mg with background chemotherapy: Inclusion of this cohort will be based on assessment of comparability between Regimens A and B in Cycle 0 for ANC and CD34+ as defined above. If performed, this regimen will be HSP 130, 3 mg, single SC injection in the deltoid region, at least 24 hours after administration of chemotherapy in Cycle 1, Cycle 2, Cycle 3, and Cycle 4, as appropriate. Conditional Regimen C (12 mg):This cohort will not be initiated until data from cycle 0 for 3 mg and 6 mg and Cycles 1-4 for 6 mg has been reviewed and analyzed.	Drug: HSP-130

Name	Type	Description	Arm Group Labels	Other Names
HSP-130	Drug	Dosage will vary per each cohort: (Five independent cohorts) Cycle 0 Regimen A - 3 mg Cycle 0 Regimen B - 6 mg Cycles 1-4 Regimen B - 6 mg Cycles 1-4 Regimen A (Potential)- 3 mg Cycles 1-4 Regimen C (Conditional)- 12 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0	Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.	Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0	AUCinf = Area under the serum concentration of HSP-130 versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).	Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
Maximum Observed Serum Concentration (Cmax): Cycle 0		Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
Duration of Severe Neutropenia (DSN): Cycle 1	Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9 per liter. DSN was defined as the days with grade 4 neutropenia (ANC < 0.5 x10^9/L).	Cycle 1: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4	AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).	Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4

Secondary Outcomes

Measure	Description	Time Frame
Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0	ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.	Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Other Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after the HSP-130 administration up to and including 30 days post HSP-130 administration (up to Day 94). AEs included both serious and non-serious.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A subject will be eligible for study participation if all of the following criteria are met at Screening:
1. Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics committee (IEC) prior to any study related activities
2. Females ≥ 18 years
3. Histologically confirmed and documented invasive breast cancer
4. Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up
5. Chemotherapy naive, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide-based regimen, e.g., TAC, as background chemotherapy
6. Zubrod/WHO/ECOG performance status ≤ 2
7. Adequate bone marrow, hepatic, and renal function reserve as evidenced by:
  1. Hemoglobin ≥ 10 mg/dl
  2. ANC ≥ 1.5 x 10^9/L
  3. Platelet count of ≥ 100 x 10^9/L
  4. Total bilirubin ≤ 2 mg/dl
  5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x the upper limit of normal (ULN) of the reference lab
  6. Serum creatinine of ≤ 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ≥ 60 mg/min
8. Body mass index (BMI) of 19 to 40 kg/m^2 , inclusive
9. Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status. Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study
  
  Medically acceptable forms of birth control can include, with approval of the treating physician:
  1. Barrier methods (condom or diaphragm with spermicide)
  2. Intrauterine device (IUD)
  3. Hormone contraceptives (such as oral [pill], injection, skin patch, implant, cervical ring)
  4. Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. Sexually active subjects must use contraception while on HSP-130 from admission to the final Follow-up Visit
10. Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study

Exclusion Criteria:

A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:
1. Previous G-CSF exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM-CSF), or any other branded or biosimilar G-CSF
2. Prior autologous stem cell harvest of any type
3. Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents
4. Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin
5. For subjects receiving doxorubicin, no concurrent use of inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp or with trastuzumab due to increased risk of cardiac dysfunction
6. Chemotherapy other than that included in this study (taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP-130, prior bone marrow or stem cell transplantation, or malignancy within 5 years
7. Known HER2 + ( overexpressing breast cancer)
8. Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer
9. ≥ Grade 2 underlying neuropathy
10. Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections
11. Treatment with systemically active antibiotics within 72 hours before chemotherapy
12. Known infection with HIV
13. Known sickle cell disease
14. Known severe persistent drug-induced myelosuppression
15. New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant ECG abnormalities) or MI within the previous 6 months before the first administration of HSP-130
16. Any malignancy other than breast cancer, with exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within 5 years before the first administration of the HSP-130
17. Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product
18. Pregnancy or lactation; Subjects planning to be pregnant or to breastfeed before, during, or within 12 months after administration of the HSP-130 are not permitted to enroll in the study
19. Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130
20. Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP-130, or patient is high risk for treatment complication

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CRU Hungary Kft.,CRU Early Phase Unit, Miskolci Semmelweis Kórház és Egyetemi Oktató Kórház		Miskolc	BAZ Megye	3529	Hungary

PubMed Identifier	Type	Citation	Retractions
34618197	Derived	Yao HM, Jones SR, Morales S, Moosavi S, Zhang J, Freyman A, Ottery FD. Phase I/II study to assess the clinical pharmacology and safety of single ascending and multiple subcutaneous doses of PF-06881894 in women with non-distantly metastatic breast cancer. Cancer Chemother Pharmacol. 2021 Dec;88(6):1033-1048. doi: 10.1007/s00280-021-04355-6. Epub 2021 Oct 7.

ID	Title	Description
FG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 milligram (mg) of HSP-130 subcutaneously (SC) at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 22, 2015	Sep 21, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0

Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Posted

Mean

Standard Deviation

hour*10^9 Neutrophils per Liter

Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG0006 OG0016

Title

Denominators

Categories

Title	Measurements
	OG0003900.482± 683.6870 OG0015880.985± 1287.2887

Primary

Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0

AUCinf = Area under the serum concentration of HSP-130 versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

hour*picogram per milliliter (h*pg/mL)

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Primary

Maximum Observed Serum Concentration (Cmax): Cycle 0

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

picogram per milliliter (pg/mL)

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Primary

Duration of Severe Neutropenia (DSN): Cycle 1

Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9 per liter. DSN was defined as the days with grade 4 neutropenia (ANC < 0.5 x10^9/L).

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.

Posted

Mean

Standard Deviation

days

Cycle 1: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Primary

Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4

AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

h*pg/mL

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Primary

Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

pg/mL

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0

ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Posted

Mean

Standard Deviation

*10^9 Neutrophils per Liter

Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts

Secondary

Time of Maximum Effect for Absolute Neutrophil Count (ANC_Tmax): Cycle 0

ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Posted

Median

Full Range

hour

Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Secondary

Area Under the Effect Curve for CD34+ (AUECCD34+): Cycle 0

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Posted

Mean

Standard Deviation

hour*cells per microliter (h*cells/ mcL)

Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Maximum Effect for CD34+ Count (CD34+_Emax): Cycle 0

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Posted

Mean

Standard Deviation

cells per microliter (cells/mcL)

Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Time of Maximum Effect for CD34+ Count (CD34+ Tmax): Cycle 0

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Posted

Median

Full Range

hour

Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 0

ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

FAS included all participants who received at least 1 dose of study medication. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.

Posted

Mean

Standard Deviation

hour*10^9 Neutrophils per Liter

Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Secondary

Area Under the Effect Curve From Time of Dose Administration to Time Infinity for CD34 + (AUEC_CD34+ Inf): Cycle 0

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm. Here "Overall number of participants analyzed" signifies number of participants evaluable for the specified outcome measure.

Posted

Mean

Standard Deviation

hour*cells per microliter (h*cells/mcL)

Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Secondary

Area Under the Serum Concentration Time Curve From the Time of Dose Administration to the Time of Last Measurable Concentration (AUCt): Cycle 0

AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

h*pg/mL

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Secondary

Time To Achieve Maximum Serum Concentration (Tmax): Cycle 0

FAS included all participants who received at least 1 dose of study medication.

Posted

Median

Full Range

hour

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Elimination Half-Life (t1/2): Cycle 0

t1/2 is the time taken for plasma concentration of HSP 130 to reduce by 50 percent (%) of its initial value.

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

hour

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Secondary

Elimination Rate Constant (λz): Cycle 0

Elimination rate constant was defined as the rate at which the drug was removed from the body.

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

per hour

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Secondary

Apparent Clearance (CL/F): Cycle 0

Clearance of a drug was defined as the rate at which a drug was metabolized or eliminated by normal biological processes.

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

milliliter per hour (mL/h)

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Secondary

Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0

The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

h*pg/mL

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Secondary

Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 0

The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

h*pg/mL

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Secondary

Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 0

The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

pg/mL

Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants

Secondary

Duration of Severe Neutropenia (DSN): Cycle 4

Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L. DSN was defined as the days with grade 4 neutropenia (ANC < 0.5 x10^9/L).

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, 'Overall number of participants analyzed" signifies number of participants evaluable for the specified outcome measure.

Posted

Mean

Standard Deviation

days

Cycle 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Absolute Neutrophil Count Nadir Concentration: Cycle 1 and Cycle 4

Nadir was defined as the lowest count for ANC concentration reported after first dose of study treatment.

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Posted

Mean

Standard Deviation

*10^9 Neutrophils per Liter

Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Time of ANC Nadir Concentration: Cycle 1 and Cycle 4

Time of ANC Nadir (in hours) was defined as the time from the first dose of study treatment on Day 2 of Cycle 1 and 4 to the time the lowest value was recorded.

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Posted

Mean

Standard Deviation

hour

Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Area Under the Effect Curve (AUEC_ANCt): Cycle 1 and Cycle 4

ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Posted

Mean

Standard Deviation

hour*10^9 Neutrophils per Liter

Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4

FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" field signifies that the number of participants were evaluable at specified time point.

Posted

Mean

Standard Deviation

hour*10^9 Neutrophils per Liter

Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4

Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 °C for >1 hour and ANC less than (<) 1.0 *10^9/L.

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Posted

Number

participants

Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Incidence of Severe Neutropenia: Cycle 1 and Cycle 4

Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L.

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Posted

Number

participants

Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Time to ANC Recovery: Cycle 1 and Cycle 4

Time to ANC recovery was defined as the time from documentation of the first day with ANC greater than equal to (>=) 2.0 x10^9/L after any day with ANC <2.0 x10^9/L.

FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Posted

Mean

Standard Deviation

days

Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4

AUC0-inf = Area under the serum concentration versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).

FAS included all participants who received at least 1 dose of study medication. Here, 'number analyzed' field signifies that the number of participants were evaluable at specified time point.

Posted

Mean

Standard Deviation

h*pg/mL

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Time To Achieve Maximum Serum Concentration (Tmax): Cycle 1 and Cycle 4

FAS included all participants who received at least 1 dose of study medication.

Posted

Median

Full Range

hour

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Elimination Half-Life (t1/2): Cycle 1 and Cycle 4

t1/2 is the time taken for plasma concentration of a drug to reduce by 50% of its initial value.

FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.

Posted

Mean

Standard Deviation

hour

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Elimination Rate Constant (λz): Cycle 1 and Cycle 4

Elimination rate constant was defined as the rate at which the drug was removed from the body.

FAS included all participants who received at least 1 dose of study medication. Here, 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.

Posted

Mean

Standard Deviation

per hour

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Apparent Clearance (CL/F): Cycle 1 and Cycle 4

CL/F was defined as a quantitative measure of the rate at which a drug substance is removed from the body.

FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.

Posted

Mean

Standard Deviation

mL/h

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4

The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

h*pg/mL

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4

The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).

FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable at the specified timepoints only.

Posted

Mean

Standard Deviation

h*pg/mL

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Secondary

Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4

The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).

FAS included all participants who received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

pg/mL

Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

ID	Title	Description
OG000	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after the HSP-130 administration up to and including 30 days post HSP-130 administration (up to Day 94). AEs included both serious and non-serious.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Baseline up to approximately Day 94

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.

Other Pre-specified

Number of Participants With Treatment-Emergent Adverse Events (AEs) of Special Interest

AEs of Special Interest (AESI) included Potential Allergic Reactions, Splenomegaly, Splenic Rupture, Acute Respiratory Distress Syndrome, Alveolar Hemorrhage, Hemoptysis, Leukocytosis, Thrombocytopenia, Capillary Leak Syndrome, Cytokine Release Syndrome, Cutaneous Vasculitis and Glomerulonephritis.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Baseline up to approximately Day 94

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG002	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Other Pre-specified

Number of Participants With Laboratory Abnormalities

Criteria: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, neutrophils); chemistry (alkaline phosphatase, glucose, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, albumin, creatinine and gamma-glutamyl transpeptidase, blood urea nitrogen, total protein, phosphate, and uric acid); urinalysis. The clinical laboratory results and patterns observed were consistent with the known therapeutic response and the safety profile for the US and EU approved pegylated filgrastim (Neulasta).

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Baseline up to approximately Day 94

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG002

Other Pre-specified

Number of Participants With Clinically Significant Vital Sign Abnormalities

Vital sign assessment included body temperature (tympanic or axillary), heart rate (sitting), blood pressure (sitting systolic and diastolic), and respiratory rate. Clinically significant abnormality was based upon investigator's discretion.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Baseline up to approximately Day 94

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG002	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Other Pre-specified

Number of Participants With Clinically Significant Physical Examination Abnormalities

Physical examination included physical assessment of the spleen. Clinically significant abnormality was based on investigator's discretion.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Baseline up to approximately Day 94

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG002	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Other Pre-specified

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

Clinically significant abnormality was based upon investigator's discretion.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Baseline up to approximately Day 94

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG002	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Other Pre-specified

Number of Participants With At Least 1 Concomitant Medication

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Baseline up to approximately Day 94

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG002	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Other Pre-specified

Duration of Exposure to Study Drug Medication

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Median

Full Range

days

Baseline up to approximately Day 94

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG002	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Other Pre-specified

Number of Participants With Positive Anti-pegfilgrastim (Anti-drug) Antibodies

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Baseline up to approximately Day 94

ID	Title	Description
OG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
OG002	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Vertigo	Ear and labyrinth disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Keratitis	Eye disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0024 affected13 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected13 at risk
Constipation	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0024 affected13 at risk
Dry mouth	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Gingival pain	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Nausea	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected6 at risk EG0027 affected13 at risk
Vomiting	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0023 affected13 at risk
Asthenia	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected13 at risk
Chest discomfort	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Chills	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Face oedema	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Fatigue	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0023 affected13 at risk
Inflammation	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Pain	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Pyrexia	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected13 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Conjunctivitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected13 at risk
Nasopharyngitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Skin infection	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Viral infection	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Wound	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Hepatic enzyme increased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Neutrophil count decreased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Platelet count decreased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
White blood cell count decreased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected13 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected6 at risk EG0012 affected6 at risk EG0024 affected13 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected13 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0023 affected13 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0023 affected13 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Arachnoid cyst	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Cerebral atrophy	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Dizziness	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Dysgeusia	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Headache	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0014 affected6 at risk EG0025 affected13 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Proteinuria	Renal and urinary disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0028 affected13 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0023 affected13 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected13 at risk
Arteriosclerosis	Vascular disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Flushing	Vascular disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Hot flush	Vascular disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Hypertension	Vascular disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected13 at risk
Hypotension	Vascular disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk
Varicose vein	Vascular disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected13 at risk

ID	Title	Description
BG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
BG001	Cycles 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
BG002	Cycles 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cycle 0: HSP-130 3mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	6	0	6	6	6
EG001	Cycle 0: HSP-130 6mg	Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	6	0	6	6	6
EG002	Cycle 1-4: HSP-130 6mg	Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.	13	2	13	13	13