Breast CancerPhase 1NCT03135951
Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
A Phase 1 study testing SPI-2012 in people with Breast Cancer and Pharmacokinetics, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Pharmacokinetics
- What is being tested?
- SPI-2012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 18 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable Stage I to Stage IIIA breast cancer.
- Candidate to receive adjuvant or neoadjuvant TC chemotherapy.
- ANC ≥1.5x10^9/L
- Platelet count ≥100x10^9/L
- Hemoglobin >9 g/dL
- Calculated creatinine clearance >50 mL/min
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- Total bilirubin ≤1.5 mg/dL
- AST and ALT ≤2.5xULN
- Alkaline phosphatase ≤2.0xULN
- ECOG ≤2
Who cannot join
- Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. If history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years.
- Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing.
- Concurrent adjuvant cancer therapy.
- Locally recurrent/metastatic breast cancer.
- Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.
- Active infection, receiving antibiotics or any serious underlying medical condition which would impair the ability of the patient to receive protocol-specified treatment.
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- Prior bone marrow or hematopoietic stem cell transplant
- Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
- Prior radiation therapy within 30 days prior to enrollment.
- Major surgery within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.
Read the detailed description
This is a Phase 1, single-arm multicenter study to evaluate the PK and safety of SPI-2012 (a long acting myeloid growth factor) in breast cancer patients treated with TC chemotherapy.
Approximately 25 patients will be enrolled.
Each cycle will be 21 days and patients will receive 4 cycles of treatment with 2 additional cycles based on the investigator's discretion. On Day 1 of each cycle, patients will receive TC chemotherapy and on Day 2 of each cycle, patients will receive SPI-2012.
Pharmacokinetics will be evaluated only in Cycles 1 and 3.
- Conditions
- Breast Cancer, Pharmacokinetics
- Being tested
- SPI-2012
- Keywords
- Breast Cancer, Pharmacokinetics, Long-acting Myeloid Growth Factor, Early Stage Breast Cancer, Docetaxel + Cyclophosphamide (TC) Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI-2012Drug
Also called Rolontis™, Eflapegrastim
Supplied in prefilled, single-use syringes for subcutaneous injection and administered on Day 2 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| SPI-2012 | Experimental | * SPI-2012 (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF per cycle)
* Supplied in 1 mL prefilled, single-use syringes for subcutaneous injection
* Administered on Day 2 of each cycle after TC administration Receives: Drug: SPI-2012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
PK samples will be collected at predetermined time intervals and Peak Concentration is measured at highest value among all concentrations.
Measured: Up to 42 days
Area under the plasma concentration versus time curve (AUC)
PK samples will be collected at predetermined time intervals. AUC is calculated in the plot of plasma concentration versus time curve
Measured: Up to 42 days
Secondary outcomes (2)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A treatment-emergent AE (TEAE) is any AE that occurs from the first dose of study treatment through 35 (±5) days after the date of patient early discontinuation.
Measured: 6 months
Population slope of the relationship between the change from baseline in QTc intervals and plasma concentrations of SPI-2012
A linear mixed effects modeling approach will be used to quantify the relationship between the plasma concentrations of SPI-2012 and change from baseline in QT intervals (∆QTc). Plasma concentration, intercept, and subject are to be included as random effects.
Measured: Up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start11 May 2017
- Primary completion19 Feb 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shanta Chawla, MD, Study director, Spectrum Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135951
- Sponsor's protocol ID
- SPI-GCF-301-PK
- Status last verified
- Nov 2020
- First submitted
- 20 Apr 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
- ClinicalTrials.gov ID
- NCT03135951
- Acronym / sponsor ID
- SPI-GCF-301-PK
- Conditions
- Breast Cancer, Pharmacokinetics
- Keywords
- Breast Cancer, Pharmacokinetics, Long-acting Myeloid Growth Factor, Early Stage Breast Cancer, Docetaxel + Cyclophosphamide (TC) Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 11 May 2017 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.
Detailed description
This is a Phase 1, single-arm multicenter study to evaluate the PK and safety of SPI-2012 (a long acting myeloid growth factor) in breast cancer patients treated with TC chemotherapy.
Approximately 25 patients will be enrolled.
Each cycle will be 21 days and patients will receive 4 cycles of treatment with 2 additional cycles based on the investigator's discretion. On Day 1 of each cycle, patients will receive TC chemotherapy and on Day 2 of each cycle, patients will receive SPI-2012.
Pharmacokinetics will be evaluated only in Cycles 1 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPI-2012 | Experimental | Drug: SPI-2012* SPI-2012 (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF per cycle) * Supplied in 1 mL prefilled, single-use syringes for subcutaneous injection * Administered on Day 2 of each cycle after TC administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable Stage I to Stage IIIA breast cancer.
- Candidate to receive adjuvant or neoadjuvant TC chemotherapy.
- ANC ≥1.5x10^9/L
- Platelet count ≥100x10^9/L
- Hemoglobin >9 g/dL
Key exclusion criteria (10 listed)
- Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. If history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years.
- Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing.
- Concurrent adjuvant cancer therapy.
- Locally recurrent/metastatic breast cancer.
- Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPI-2012Also: Rolontis™, EflapegrastimSupplied in prefilled, single-use syringes for subcutaneous injection and administered on Day 2 of each cycle. | Drug | SPI-2012 |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: Up to 42 days
PK samples will be collected at predetermined time intervals and Peak Concentration is measured at highest value among all concentrations.
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 42 days
PK samples will be collected at predetermined time intervals. AUC is calculated in the plot of plasma concentration versus time curve
2 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 6 months
Population slope of the relationship between the change from baseline in QTc intervals and plasma concentrations of SPI-2012
Time frame: Up to 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanta Chawla, MD study director
Spectrum Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPI-2012 in people with Breast Cancer and Pharmacokinetics, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: Up to 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.