NeutropeniaPhase 1NCT04187898
Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer
A Phase 1 study testing Eflapegrastim, Docetaxel and Cyclophosphamide in people with Neutropenia and Breast Cancer, run by Spectrum Pharmaceuticals, Inc at 8 sites in United States.
Trial summary
The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neutropenia, Breast Cancer
- What is being tested?
- Eflapegrastim, Docetaxel and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Mar 2020to 16 Aug 2024
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and capable of giving written Informed Consent and able to adhere to study drug dosing time and blood draw schedules
- New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
- Candidate to receive adjuvant or neoadjuvant TC chemotherapy
- Age must be at least 18 years for the Early Phase, and between 18 to ≤55 years for the Expansion Phase
- ANC ≥1.5×10^9/liter (L).
- Platelet count ≥100×10^9/liter (L).
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- Hemoglobin >10 grams per deciliter (g/dL).
- Calculated creatinine clearance >50 milliliter per minute (mL/min).
- Total bilirubin ≤1.5 milligrams per deciliter (mg/dL).
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤2.5×upper limit of normal (ULN).
- Alkaline phosphatase ≤2.0×ULN.
- Eastern Cooperative Oncology Group (ECOG) ≤2
- Willing to practice 2 forms of contraceptives (1 must be a barrier method), from study entry through 30 days after last dose of study drug/ early discontinuation
- Negative urine pregnancy test within 30 days before randomization
Who cannot join
- Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
- Known sensitivity to Escherichia coli (E. coli) derived products
- Concurrent adjuvant cancer therapy other than the trial-specified therapies
- Locally recurrent/metastatic breast cancer
- Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 3 months prior to the administration of study drug
- Receiving anti-infectives, has an underlying medical condition or other serious illness that would impair the ability to receive protocol-specified treatment
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- 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 bone marrow or stem cell transplant
- Prior radiation therapy within 30 days prior to enrollment
- Major surgery within 30 days prior to enrollment
- Pregnant or breastfeeding
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Pacific Cancer Medical Center
Anaheim, California, 92801
SCL Health Research Institute, Inc.
Billings, Montana, 59102
City of Hope
Long Beach, California, 90813
BRCR Medical Center, Inc.
Plantation, Florida, 33322
ACRC/ Arizona Clinical Research Center
Tucson, Arizona, 85715
Bond & Steele Clinic, P.A.
Winter Haven, Florida, 33881
Mercy Health Youngstown
Youngstown, Ohio, 44501
Yuma Regional Medical Center Cancer Center
Yuma, Arizona, 85364
About this study
Official title: Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After the Same-Day, Varying Dosing Time Schedules of Eflapegrastim Administration in Patients With Breast-Cancer Receiving Docetaxel and Cyclophosphamide
The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration.
Read the detailed description
This is a Phase 1, randomized, open label, actively-controlled study to evaluate the same day dosing of Eflapegrastim on duration of neutropenia when administered at varying intervals following Docetaxel and Cyclophosphamide (TC) chemotherapy in patients with early-stage breast cancer.
The study will be conducted in two phases: Early Phase and Expansion Phase.
- In the Early Phase, approximately 45 patients were enrolled and randomized in a 1:1:1 ratio to 3 dosing time schedule arms. Each cycle was of 21 days. Total 4 cycles were evaluated for this phase. On Day 1 of Cycle 1, patients received Docetaxel and Cyclophosphamide (TC) chemotherapy followed by administration of Eflapegrastim at 1 of 3-time schedules post-TC (30 minutes [mins], 3 hours or 5 hours). During Cycles 2-4, patients received Eflapegrastim 24 hours after TC administration (on Day 2).
- In the Expansion Phase, additional 45 patients will be enrolled in Cycles 1-4, who will receive fixed dose of Eflapegrastim 30 mins after TC administration (on Day 1).
Safety evaluations will be conducted once the first 3 patients (for Early Phase) and the first 6 patients (for Expansion Phase) have completed Cycle 1 to determine if it is safe for patients to continue in that particular treatment arm.
- Conditions
- Neutropenia, Breast Cancer
- Being tested
- Eflapegrastim, Docetaxel, Cyclophosphamide
- Keywords
- Neutropenia, Early Stage Breast Cancer, Long-acting Myeloid Growth Factor, Docetaxel + Cyclophosphamide (TC) Chemotherapy
- Medical subject headings
- Neutropenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EflapegrastimBiological
Administered in Cycle 1, 30 minutes after TC chemotherapy.
Administered in Cycles 2-4, on day 2 of each cycle.
EflapegrastimBiological
Administered in Cycle 1, 3 hours after TC chemotherapy.
Administered in Cycles 2-4, on day 2 of each cycle.
EflapegrastimBiological
Administered in Cycle 1, 5 hours after TC chemotherapy.
Administered in Cycles 2-4, on day 2 of each cycle.
EflapegrastimBiological
Administered in Cycles 1-4, 30 mins after TC chemotherapy.
DocetaxelDrug
Also called Taxotere
75 mg/m^2 IV infusion.
Administered on Day 1 of each cycle.
CyclophosphamideDrug
Also called Cytoxan
600 mg/m^2 IV infusion.
Administered on Day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Early Phase: Eflapegrastim @ 30mins post TC | Experimental | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg granulocyte colony-stimulating factor [G-CSF]).
Supplied in prefilled single-use syringes for subcutaneous injection.
Cycle 1: Administered on the same day as TC chemotherapy, 30 minutes from the end of TC administration.
Cycles 2-4: Administered 24 hours after TC chemotherapy administration.
Each cycle is 21 days. Receives: Biological: Eflapegrastim; Drug: Docetaxel; Drug: Cyclophosphamide |
| Early Phase: Eflapegrastim @ 3 hours post TC | Experimental | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF).
Supplied in prefilled single-use syringes for subcutaneous injection.
Cycle 1: Administered on the same day as TC chemotherapy, 3 hours from the end of TC administration.
Cycles 2-4: Administered 24 hours after TC chemotherapy administration.
Each cycle is 21 days. Receives: Biological: Eflapegrastim; Drug: Docetaxel; Drug: Cyclophosphamide |
| Early Phase: Eflapegrastim @ 5 hours post TC | Experimental | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF).
Supplied in prefilled single-use syringes for subcutaneous injection.
Cycle 1: Administered on the same day as TC chemotherapy, 5 hours from the end of TC administration.
Cycles 2-4: Administered 24 hours after TC chemotherapy administration.
Each cycle is 21 days. Receives: Biological: Eflapegrastim; Drug: Docetaxel; Drug: Cyclophosphamide |
| Expansion Phase: Eflapegrastim @ 30 mins post TC | Experimental | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF).
Supplied in prefilled single-use syringes for subcutaneous injection.
Cycles 1-4: Administered on the same day as TC chemotherapy, 30 minutes following the end of TC administration.
Each cycle is 21 days. Receives: Biological: Eflapegrastim; Drug: Docetaxel; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recovery of Absolute Neutrophil Count (ANC) From Nadir to ≥1.5×10^9/L in Cycle 1
Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×10^9/liter (L) after the expected nadir.
Measured: Cycle 1 is 21 days
Secondary outcomes (11)
Duration of Grade 4 Neutropenia (DSN) in Cycle 1
DSN is defined as the number of days of severe neutropenia where the ANC<0.5x10^9/L from the first occurrence of an ANC below the threshold.
Measured: Cycle 1 is 21 days
Proportion of Patients With Grade 4 Neutropenia in Cycle 1
Measured: Cycle 1 is 21 days
Incidence of Grade 3 Febrile Neutropenia (FN) in Cycle 1
FN is defined as having an ANC<1.0x10^9/L and either a single temperature of >38.3 degrees Celsius (101.0 Fahrenheit [F]) or a sustained temperature of >38.0 degrees Celsius (100.4 F).
Measured: Cycle 1 is 21 days
Incidence of Neutropenic Complications, Including Hospitalization due to Neutropenia, FN, and use of Anti-infectives During Cycle 1
Measured: Cycle 1 is 21 days
Expansion Phase: Time to Recovery of ANC From Nadir to ≥1.5×10^9/L in Cycles 2-4
Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×10^9/L after the expected nadir.
Measured: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: DSN in Cycles 2-4
DSN is defined as the number of days of severe neutropenia where the ANC <0.5x10^9/L from the first occurrence of an ANC below the threshold.
Measured: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Proportion of Patients With Grade 4 Neutropenia in Cycles 2-4
Measured: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Incidence of FN in Cycles 2-4
FN is defined as having an ANC<1.0x10^9/L and either a single temperature of >38.3 degrees Celsius (101.0 F) or a sustained temperature of >38.0 degrees Celsius (100.4 F).
Measured: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Incidence of Neutropenic Complications, Including Hospitalization due to Neutropenia, FN, and use of Anti-infectives During Cycles 2-4
Measured: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety
Measured: Up to approximately 40 days after the last dose of study treatment or early study discontinuation (up to approximately 4 months)
Proportion of Patients Discontinuing Because of a TEAE
Measured: Up to approximately 40 days after the last dose of study treatment or early study discontinuation (up to approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start11 Mar 2020
- Primary completion16 Jul 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Considering two-phase study, where Expansion Phase followed Early Phase. The dosing within the Early Phase was in parallel assignment wherein participants were assigned to three arms in a 1:1:1 ratio. Patients completing Early Phase will enter the Expansion Phase to receive dosing in a single arm.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187898
- Sponsor's protocol ID
- SPI-GCF-104
- Status last verified
- Sep 2024
- First submitted
- 30 Oct 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After the Same-Day, Varying Dosing Time Schedules of Eflapegrastim Administration in Patients With Breast-Cancer Receiving Docetaxel and Cyclophosphamide
- ClinicalTrials.gov ID
- NCT04187898
- Acronym / sponsor ID
- SPI-GCF-104
- Conditions
- Neutropenia, Breast Cancer
- Keywords
- Neutropenia, Early Stage Breast Cancer, Long-acting Myeloid Growth Factor, Docetaxel + Cyclophosphamide (TC) Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 5 Dec 2019 (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 compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration.
Detailed description
This is a Phase 1, randomized, open label, actively-controlled study to evaluate the same day dosing of Eflapegrastim on duration of neutropenia when administered at varying intervals following Docetaxel and Cyclophosphamide (TC) chemotherapy in patients with early-stage breast cancer.
The study will be conducted in two phases: Early Phase and Expansion Phase.
- In the Early Phase, approximately 45 patients were enrolled and randomized in a 1:1:1 ratio to 3 dosing time schedule arms. Each cycle was of 21 days. Total 4 cycles were evaluated for this phase. On Day 1 of Cycle 1, patients received Docetaxel and Cyclophosphamide (TC) chemotherapy followed by administration of Eflapegrastim at 1 of 3-time schedules post-TC (30 minutes [mins], 3 hours or 5 hours). During Cycles 2-4, patients received Eflapegrastim 24 hours after TC administration (on Day 2).
- In the Expansion Phase, additional 45 patients will be enrolled in Cycles 1-4, who will receive fixed dose of Eflapegrastim 30 mins after TC administration (on Day 1).
Safety evaluations will be conducted once the first 3 patients (for Early Phase) and the first 6 patients (for Expansion Phase) have completed Cycle 1 to determine if it is safe for patients to continue in that particular treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Considering two-phase study, where Expansion Phase followed Early Phase. The dosing within the Early Phase was in parallel assignment wherein participants were assigned to three arms in a 1:1:1 ratio. Patients completing Early Phase will enter the Expansion Phase to receive dosing in a single arm.
| Arm | Type | Receives |
|---|---|---|
| Early Phase: Eflapegrastim @ 30mins post TC | Experimental | Biological: Eflapegrastim, Drug: Docetaxel, Drug: CyclophosphamideEflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg granulocyte colony-stimulating factor [G-CSF]). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 30 minutes from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days. |
| Early Phase: Eflapegrastim @ 3 hours post TC | Experimental | Biological: Eflapegrastim, Drug: Docetaxel, Drug: CyclophosphamideEflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 3 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days. |
| Early Phase: Eflapegrastim @ 5 hours post TC | Experimental | Biological: Eflapegrastim, Drug: Docetaxel, Drug: CyclophosphamideEflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 5 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days. |
| Expansion Phase: Eflapegrastim @ 30 mins post TC | Experimental | Biological: Eflapegrastim, Drug: Docetaxel, Drug: CyclophosphamideEflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycles 1-4: Administered on the same day as TC chemotherapy, 30 minutes following the end of TC administration. Each cycle is 21 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Willing and capable of giving written Informed Consent and able to adhere to study drug dosing time and blood draw schedules
- New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
- Candidate to receive adjuvant or neoadjuvant TC chemotherapy
- Age must be at least 18 years for the Early Phase, and between 18 to ≤55 years for the Expansion Phase
- ANC ≥1.5×10^9/liter (L).
Key exclusion criteria (11 listed)
- Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
- Known sensitivity to Escherichia coli (E. coli) derived products
- Concurrent adjuvant cancer therapy other than the trial-specified therapies
- Locally recurrent/metastatic breast cancer
- Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 3 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 |
|---|---|---|
| EflapegrastimAdministered in Cycle 1, 30 minutes after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle. | Biological | Early Phase: Eflapegrastim @ 30mins post TC |
| EflapegrastimAdministered in Cycle 1, 3 hours after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle. | Biological | Early Phase: Eflapegrastim @ 3 hours post TC |
| EflapegrastimAdministered in Cycle 1, 5 hours after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle. | Biological | Early Phase: Eflapegrastim @ 5 hours post TC |
| EflapegrastimAdministered in Cycles 1-4, 30 mins after TC chemotherapy. | Biological | Expansion Phase: Eflapegrastim @ 30 mins post TC |
| DocetaxelAlso: Taxotere75 mg/m^2 IV infusion. Administered on Day 1 of each cycle. | Drug | Early Phase: Eflapegrastim @ 3 hours post TC, Early Phase: Eflapegrastim @ 30mins post TC, Early Phase: Eflapegrastim @ 5 hours post TC, Expansion Phase: Eflapegrastim @ 30 mins post TC |
| CyclophosphamideAlso: Cytoxan600 mg/m^2 IV infusion. Administered on Day 1 of each cycle. | Drug | Early Phase: Eflapegrastim @ 3 hours post TC, Early Phase: Eflapegrastim @ 30mins post TC, Early Phase: Eflapegrastim @ 5 hours post TC, Expansion Phase: Eflapegrastim @ 30 mins post TC |
Primary outcome
Time to Recovery of Absolute Neutrophil Count (ANC) From Nadir to ≥1.5×10^9/L in Cycle 1
Time frame: Cycle 1 is 21 days
Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×10^9/liter (L) after the expected nadir.
11 secondary outcomes
Duration of Grade 4 Neutropenia (DSN) in Cycle 1
Time frame: Cycle 1 is 21 days
Proportion of Patients With Grade 4 Neutropenia in Cycle 1
Time frame: Cycle 1 is 21 days
Incidence of Grade 3 Febrile Neutropenia (FN) in Cycle 1
Time frame: Cycle 1 is 21 days
Incidence of Neutropenic Complications, Including Hospitalization due to Neutropenia, FN, and use of Anti-infectives During Cycle 1
Time frame: Cycle 1 is 21 days
Expansion Phase: Time to Recovery of ANC From Nadir to ≥1.5×10^9/L in Cycles 2-4
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: DSN in Cycles 2-4
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Proportion of Patients With Grade 4 Neutropenia in Cycles 2-4
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Incidence of FN in Cycles 2-4
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Incidence of Neutropenic Complications, Including Hospitalization due to Neutropenia, FN, and use of Anti-infectives During Cycles 2-4
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety
Time frame: Up to approximately 40 days after the last dose of study treatment or early study discontinuation (up to approximately 4 months)
Proportion of Patients Discontinuing Because of a TEAE
Time frame: Up to approximately 40 days after the last dose of study treatment or early study discontinuation (up to approximately 4 months)
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eflapegrastim, Docetaxel and Cyclophosphamide in people with Neutropenia and Breast Cancer, run by Spectrum Pharmaceuticals, Inc at 8 sites 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 14 inclusion and 11 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Time to Recovery of Absolute Neutrophil Count (ANC) From Nadir to ≥1.5×10^9/L in Cycle 1 (time frame: Cycle 1 is 21 days). 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 19 Sep 2024.