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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01724866




Registration number
NCT01724866
Ethics application status
Date submitted
24/10/2012
Date registered
12/11/2012
Date last updated
15/04/2022

Titles & IDs
Public title
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Scientific title
Phase 2, Open-Label, Dose-Ranging Study of SPI-2012 (HM10460A) or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophosphamide (TC) Regimen
Secondary ID [1] 0 0
2013-003094-10
Secondary ID [2] 0 0
SPI-GCF-12-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neutropenia 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SPI-2012
Treatment: Drugs - Pegfilgrastim
Treatment: Drugs - Docetaxel
Treatment: Drugs - Cyclophosphamide

Experimental: Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) - Participants received SPI-2012 45 microgram/kilogram (µg/kg), subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:

Docetaxel 75 milligram/ square metre (mg/m\^2) intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.

Experimental: Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC) - Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:

Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.

Experimental: Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC) - Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:

Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.

Experimental: Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) - Participants received Pegfilgrastim 6 milligram (mg), SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:

Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.


Treatment: Drugs: SPI-2012
SPI-2012 SC injection.

Treatment: Drugs: Pegfilgrastim
Pegfilgrastim SC injection, per manufacturer's Prescribing Information.

Treatment: Drugs: Docetaxel
Docetaxel given based on standard dose for chemotherapy.

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide given based on standard dose for chemotherapy.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of Severe Neutropenia (DSN) in Cycle 1
Timepoint [1] 0 0
Cycle 1 (each cycle was 21 days)
Secondary outcome [1] 0 0
Duration of DSN in Cycle 2
Timepoint [1] 0 0
Cycle 2 (each cycle was 21 days)
Secondary outcome [2] 0 0
Duration of DSN in Cycle 3
Timepoint [2] 0 0
Cycle 3 (each cycle was 21 days)
Secondary outcome [3] 0 0
Duration of DSN in Cycle 4
Timepoint [3] 0 0
Cycle 4 (each cycle was 21 days)
Secondary outcome [4] 0 0
Time to ANC Recovery in Cycle 1
Timepoint [4] 0 0
Cycle 1 (each cycle was 21 days)
Secondary outcome [5] 0 0
Time to ANC Recovery in Cycle 2
Timepoint [5] 0 0
Cycle 2 (each cycle was 21 days)
Secondary outcome [6] 0 0
Time to ANC Recovery in Cycle 3
Timepoint [6] 0 0
Cycle 3 (each cycle was 21 days)
Secondary outcome [7] 0 0
Time to ANC Recovery in Cycle 4
Timepoint [7] 0 0
Cycle 4 (each cycle was 21 days)
Secondary outcome [8] 0 0
Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1
Timepoint [8] 0 0
Cycle 1 (each cycle was 21 days)
Secondary outcome [9] 0 0
Absolute ANC Nadir Overtime in Cycle 2
Timepoint [9] 0 0
Cycle 2 (each cycle was 21 days)
Secondary outcome [10] 0 0
Absolute ANC Nadir Overtime in Cycle 3
Timepoint [10] 0 0
Cycle 3 (each cycle was 21 days)
Secondary outcome [11] 0 0
Absolute ANC Nadir Overtime in Cycle 4
Timepoint [11] 0 0
Cycle 4 (each cycle was 21 days)
Secondary outcome [12] 0 0
Depth of ANC Nadir in Cycle 1
Timepoint [12] 0 0
Cycle 1 (each cycle was 21 days)
Secondary outcome [13] 0 0
Depth of ANC Nadir in Cycle 2
Timepoint [13] 0 0
Cycle 2 (each cycle was 21 days)
Secondary outcome [14] 0 0
Depth of ANC Nadir in Cycle 3
Timepoint [14] 0 0
Cycle 3 (each cycle was 21 days)
Secondary outcome [15] 0 0
Depth of ANC Nadir in Cycle 4
Timepoint [15] 0 0
Cycle 4 (each cycle was 21 days)
Secondary outcome [16] 0 0
Time to ANC Nadir in Cycle 1
Timepoint [16] 0 0
Cycle 1 (each cycle was 21 days)
Secondary outcome [17] 0 0
Time to ANC Nadir in Cycle 2
Timepoint [17] 0 0
Cycle 2 (each cycle was 21 days)
Secondary outcome [18] 0 0
Time to ANC Nadir in Cycle 3
Timepoint [18] 0 0
Cycle 3 (each cycle was 21 days)
Secondary outcome [19] 0 0
Time to ANC Nadir in Cycle 4
Timepoint [19] 0 0
Cycle 4 (each cycle was 21 days)
Secondary outcome [20] 0 0
Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4
Timepoint [20] 0 0
Cycle 1 to Cycle 4 (each cycle was 21 days)
Secondary outcome [21] 0 0
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities
Timepoint [21] 0 0
From the first dose up to 30 days post last dose of study drug (up to 4 months)
Secondary outcome [22] 0 0
Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4
Timepoint [22] 0 0
All cycles from Cycle 1 to Cycle 4 (each cycle was 21 days)
Secondary outcome [23] 0 0
Number of Participants With Positive Antibodies for SPI-2012
Timepoint [23] 0 0
Up to the end of the study (Approximately 3.5 months)
Secondary outcome [24] 0 0
Time to Reach Maximum Concentration of SPI-2012 (Tmax)
Timepoint [24] 0 0
Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
Secondary outcome [25] 0 0
Maximum Concentration of SPI-2012 (Cmax)
Timepoint [25] 0 0
Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
Secondary outcome [26] 0 0
Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312)
Timepoint [26] 0 0
Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
Secondary outcome [27] 0 0
Half-life of SPI-2012 (t1/2)
Timepoint [27] 0 0
Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)

Eligibility
Key inclusion criteria
* Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy
* Candidate for docetaxel and cyclophosphamide chemotherapy
* Female or male at least 18 years of age
* Eastern Cooperative Oncology Group (ECOG) = 2
* Absolute neutrophil count (ANC) = 1.5×109/L
* Platelet count = 100 x 10^9/L
* Creatinine = 1.5 x upper limit of normal (ULN)
* Total bilirubin =1.5 mg/dL(= 25.65 µmol/L).
* Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) = 2.5 x ULN
* Hemoglobin > 9 g/dL
* Alkaline phosphatase = 1.5 x ULN
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known sensitivity to E. coli-derived products or known sensitivity to any of the products to be administered
* Known Human Immunodeficiency Virus (HIV) infection
* Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease
* Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment
* Prior bone marrow or stem cell transplant
* Prolonged exposure to glucocorticosteroids and immunosuppressive agents

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/08/2014
Sample size
Target
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Frankston Hospital - Frankston
Recruitment hospital [2] 0 0
Royal Hobart - Brisbane
Recruitment hospital [3] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [4] 0 0
Breast Cancer Research Center, WA - Perth
Recruitment hospital [5] 0 0
Ballarat Oncology & Haematology - Wendouree
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
7000 - Brisbane
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment postcode(s) [5] 0 0
3355 - Wendouree
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
Georgia
State/province [6] 0 0
Batumi
Country [7] 0 0
Georgia
State/province [7] 0 0
Tbilisi
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
Hungary
State/province [9] 0 0
Debrecen
Country [10] 0 0
Hungary
State/province [10] 0 0
Nyíregyháza
Country [11] 0 0
Israel
State/province [11] 0 0
Zefat
Country [12] 0 0
Poland
State/province [12] 0 0
Grudziadz
Country [13] 0 0
Poland
State/province [13] 0 0
Kraków
Country [14] 0 0
Poland
State/province [14] 0 0
Racibórz
Country [15] 0 0
Poland
State/province [15] 0 0
Warszawa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spectrum Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT01724866
Trial related presentations / publications
Vacirca JL, Chan A, Mezei K, Adoo CS, Papai Z, McGregor K, Okera M, Horvath Z, Landherr L, Hanslik J, Hager SJ, Ibrahim EN, Rostom M, Bhat G, Choi MR, Reddy G, Tedesco KL, Agajanian R, Lang I, Schwartzberg LS. An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer. Cancer Med. 2018 May;7(5):1660-1669. doi: 10.1002/cam4.1388. Epub 2018 Mar 23.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01724866