Chemotherapy-induced NeutropeniaPhase 2NCT03559387
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
A Phase 2 study testing ANF-RHO™ and Neulasta® in people with Chemotherapy-induced Neutropenia, run by Prolong Pharmaceuticals at 8 sites in 2 countries.
Trial summary
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Neutropenia
- What is being tested?
- ANF-RHO™ and Neulasta®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 3 Aug 2017to 22 May 2018
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients, 18 years of age or older
- Signed and dated written consent/assent by the patient or legally authorized representative
- Histologically confirmed non-metastatic breast cancer
- ECOG performance status ≤ 2
- Myelosuppressive chemotherapy naive
- Scheduled to receive and anticipated to complete the following chemotherapy regimen
Show all 25Show fewer
- FEC (fluorouracil/epirubicin (100) / cyclophosphamide) (3 cycles);
- Docetaxel (3 cycles) chemotherapy
- White blood cells (WBC) ≥ 3 × 10^9/L; Absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L; platelet count ≥ 100 × 10^9/L; and hemoglobin ≥ 10 g/dL (6.2 mmol/L)
- Adequate cardiac function (e.g. LVEF > 50% as determined by standard care) and adequate hepatic function (e.g. liver transaminases < 2.5 x ULN)
- Women of childbearing potential with a negative serum pregnancy test and using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives and intrauterine devices (IUDs)). Periodic abstinence is not an acceptable contraceptive method during the study period.
- Exclusion Criteria: A subject will not be enrolled if any they meet any of the following criteria:
- Known hypersensitivity to E.coli derived products or polyethylene glycol
- No other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥ 5 years ago with curative intent
- Evidence of myelodysplasia, aplastic anemia, myelofibrosis, rheumatoid arthritis, systemic lupus erythematosus, or sickle cell disease
- Clinical diagnosis or history of chronic infection such as hepatitis B virus (HBV), hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or history of tuberculosis
- Previous exposure to filgrastim, perfilgrastim or lipegfilgrastim within 30 days before randomization
- Treatment with systemically active antibiotics within 72 hours before chemotherapy
- Chronic use of oral corticosteroids
- Participation in a pharmacological clinical trial within 30 days before randomization
- Clinical diagnosis of drug abuse or substance abuse within 30 days prior to screening
- Documented alcohol abuse within 30 days prior to screening
- Unwilling and/or not capable of ensuring compliance with the provisions of the study protocol
- Pregnant or breastfeeding women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum HCG laboratory test
- Other serious medical condition that would prevent individual from receiving protocol treatment
Who cannot join
None listed.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France4 sites
Hôpital Saint Louis - Center des Maladies du Sein
Paris, 75475
Institut de cancérologie Jean Godinot
Reims, 51100
Strasbourg Oncologie Libérale
Strasbourg, 67000
CHU de Tours
Tours, 37044
Netherlands4 sites
Erasmus Medical Center
Rotterdam, 3008
Ikazia Ziekenhuis
Rotterdam, 3038
Maasstad Ziekenhuis
Rotterdam, 3079
Franciscus Gasthuis & Vlietland
Schiedam, 3118
About this study
Official title: A Randomized and Open-label Dose-finding, Ph. 2, Efficacy, Safety, and Pharmacokinetic Study of Once-per-cycle Prophylactic Injections of ANF-RHO™ Versus Pegfilgrastim (Neulasta®) in Non-metastatic Breast Cancer Patients at High-risk of Chemotherapy-induced Neutropenia
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia
Read the detailed description
Forty Eight (48) adult female, chemotherapy treatment-naïve, stage I to III, breast cancer patients scheduled to receive FEC100 (3 cycles)/docetaxel (3 cycles) myelosuppressive chemotherapy will be enrolled into the study after they meet all the inclusion/exclusion criteria. Four (4) Cohorts of 12 patients each will be studied; they will be randomized either in the ANF-RHO™ treatment arm at different doses (10 μg/kg, 20 μg/kg, or 30 μg/kg, for the cohorts 1-3, respectively) or Neulasta® (6 mg / 0.6 ml SC injection, for cohort 4). For the cohorts 1-3, 12 patients from each of the respective ANF-RHO™ cohorts will be randomized with four patients from cohort 4 (Neulasta®). Patients in the ANF-RHO™ cohorts will receive study drug on Day 1 of each Chemotherapy cycle. Patients in the Neulasta® cohort will receive study drug on Day 2 of each Chemotherapy cycle. Doses of ANF-RHO™/Neulasta® will be provided for a total of 6 cycles (21 days each). The total duration of the study 129 ± 2 days (126 Days of treatment period followed by end of study visit)
- Conditions
- Chemotherapy-induced Neutropenia
- Being tested
- ANF-RHO™, Neulasta®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANF-RHO™Drug
Also called Pegylated Granulocyte Colony-Stimulating Factor (PEG-GCSF)
Subjects randomized to the ANF-RHO™ treatment arm will receive the investigational product on Day 1(day of chemotherapy treatment) of each Chemotherapy cycle. ANF-RHO™ will be administered to the subjects as a subcutaneous injection. Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg.
ANF-RHO™ is provided as a single-use glass vial containing 1.0 ml of solution at a concentration of 5 mg/ml
Neulasta®Drug
Also called Pegylated Granulocyte Colony-Stimulating Factor (PEG-GCSF)
Subjects randomized to the Neulasta® treatment arm will receive the comparator drug on Day 2(day after chemotherapy treatment) of each Chemotherapy cycle. Neulasta® will be administered to the subjects at a standard dose of 6.0 mg in 0.6 ml as a subcutaneous injection.
Neulasta® is also provided as a single-use pre-filled syringe.
| Study group | Role | What they receive |
|---|---|---|
| ANF-RHO™ | Experimental | Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg as a subcutaneous injection. Receives: Drug: ANF-RHO™ |
| Neulasta® | Active comparator | Neulasta® will be administered to the subjects at a dose of 6.0 mg in 0.6 ml as a subcutaneous injection. Receives: Drug: Neulasta® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the first cycle of chemotherapy (FE100C).
Measured: 21 days
Secondary outcomes (25)
Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the fourth cycle of chemotherapy (docetaxel).
Measured: 21 days
Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the first chemotherapy cycle (21-day cycle FE100C)
Measured: 21 days
Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the fourth chemotherapy cycle (21-day cycle docetaxel)
Measured: 21 days
Incidence of severe neutropenia (ANC < 0.5 x 10^9/L) during all chemotherapy cycles
Measured: ~ 128 ± 2 days
Incidence and duration of febrile neutropenia defined as peak temperature ≥38.5°C and ANC < 0.5 x 10^9/L, during all chemotherapy cycles
Measured: ~ 128 ± 2 days
Incidence and duration of febrile neutropenia defined as peak temperature ≥38.0°C for two readings over two hours and ANC < 0.5 x 10^9/L, during all chemotherapy cycles
Measured: ~ 128 ± 2 days
Incidence and duration of infection and infection-related events based on use of antibiotics during all chemotherapy cycles
Measured: ~ 128 ± 2 days
Incidence and duration of infection and infection-related events based on the need for hospitalization during all chemotherapy cycles
Measured: ~ 128 ± 2 days
Incidence and duration of moderate (ANC ≥ 50 x 10^9/L) leukocytosis during all chemotherapy cycles
Measured: ~ 128 ± 2 days
Incidence and duration of severe (ANC ≥ 100 x 10^9/L) leukocytosis during all chemotherapy cycles
Measured: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Blood pressure
Assessment of Blood pressure (systolic and diastolic) helps determine the safety of the medications under study - ANF-RHO and Neulasta
Measured: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Heart rate
Assessment of Heart rate helps determine the safety of the medications under study - ANF-RHO and Neulasta
Measured: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Respiratory rate
Assessment of Respiratory rate helps determine the safety of the medications under study - ANF-RHO and Neulasta
Measured: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Body Temperature
Assessment of Respiratory rate helps determine the safety of the medications under study - ANF-RHO and Neulasta
Measured: ~ 128 ± 2 days
Incidence of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Measured: ~ 128 ± 2 days
Duration of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Measured: ~ 128 ± 2 days
Severity of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Measured: ~ 128 ± 2 days
Site of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Measured: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of Maximum Plasma Concentration (Cmax)
Cmax is the maximum concentration of the drug (either ANF-RHO or Neulasta) that is achieved after administration of a dose
Measured: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of Time taken to reach the maximum concentration (Tmax)
Tmax is the time taken to reach the maximum concentration (Cmax) after administration of a dose.
Measured: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of half-life (T1/2)
T1/2 is the time taken for ANF-RHO and Neulasta to reach half the value of their initial concentrations. T1/2 determination helps in understanding the duration for which ANF-RHO or Neulasta would be active upon administration.
Measured: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-t])
AUC[0-t] is an important parameter for determining as to how much of the drug is available in the body after administration of a drug formulation, in this case ANF-RHO vs Neulasta. Understanding the AUC for both these drug formulations will help us to determine the efficacy and safety profiles of these medicines.
Measured: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-∞])
Similar to AUC[0-t] which is estimated till time 't', in AUC[0-∞], the estimation is done on the concentration of the drug to an infinite time. Calculation of the AUC[0-∞], helps understand how much of the drug is available in the body at extremely low concentrations, beyond the limits of measurable concentrations.
Measured: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-t]/AUC[0-∞])
The parameter AUC[0-t]/AUC[0-∞] is useful to calculate the fraction of the Total AUC that was added due to the extrapolated AUC (AUC[0-∞]). It helps understand if the methods employed for determining the total AUC and drug's availability in the body are correct.
Measured: ~ 128 ± 2 days
Incidence of anti-drug antibodies to ANF-RHO and Neulasta
Measured: ~ 128 ± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start3 Aug 2017
- Primary completion18 Apr 2018
- Study completion22 May 2018
Why it stopped: Study redesign
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolong Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559387
- Sponsor's protocol ID
- PGFN-001
- Status last verified
- Jun 2018
- First submitted
- 10 May 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Open-label Dose-finding, Ph. 2, Efficacy, Safety, and Pharmacokinetic Study of Once-per-cycle Prophylactic Injections of ANF-RHO™ Versus Pegfilgrastim (Neulasta®) in Non-metastatic Breast Cancer Patients at High-risk of Chemotherapy-induced Neutropenia
- ClinicalTrials.gov ID
- NCT03559387
- Acronym / sponsor ID
- PGFN-001
- Conditions
- Chemotherapy-induced Neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study redesign
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Prolong PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 18 Jun 2018 (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.
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia
Detailed description
Forty Eight (48) adult female, chemotherapy treatment-naïve, stage I to III, breast cancer patients scheduled to receive FEC100 (3 cycles)/docetaxel (3 cycles) myelosuppressive chemotherapy will be enrolled into the study after they meet all the inclusion/exclusion criteria. Four (4) Cohorts of 12 patients each will be studied; they will be randomized either in the ANF-RHO™ treatment arm at different doses (10 μg/kg, 20 μg/kg, or 30 μg/kg, for the cohorts 1-3, respectively) or Neulasta® (6 mg / 0.6 ml SC injection, for cohort 4). For the cohorts 1-3, 12 patients from each of the respective ANF-RHO™ cohorts will be randomized with four patients from cohort 4 (Neulasta®). Patients in the ANF-RHO™ cohorts will receive study drug on Day 1 of each Chemotherapy cycle. Patients in the Neulasta® cohort will receive study drug on Day 2 of each Chemotherapy cycle. Doses of ANF-RHO™/Neulasta® will be provided for a total of 6 cycles (21 days each). The total duration of the study 129 ± 2 days (126 Days of treatment period followed by end of study visit)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANF-RHO™ | Experimental | Drug: ANF-RHO™Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg as a subcutaneous injection. |
| Neulasta® | Active comparator | Drug: Neulasta®Neulasta® will be administered to the subjects at a dose of 6.0 mg in 0.6 ml as a subcutaneous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Adult female patients, 18 years of age or older
- Signed and dated written consent/assent by the patient or legally authorized representative
- Histologically confirmed non-metastatic breast cancer
- ECOG performance status ≤ 2
- Myelosuppressive chemotherapy naive
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ANF-RHO™Also: Pegylated Granulocyte Colony-Stimulating Factor (PEG-GCSF)Subjects randomized to the ANF-RHO™ treatment arm will receive the investigational product on Day 1(day of chemotherapy treatment) of each Chemotherapy cycle. ANF-RHO™ will be administered to the subjects as a subcutaneous injection. Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg. ANF-RHO™ is provided as a single-use glass vial containing 1.0 ml of solution at a concentration of 5 mg/ml | Drug | ANF-RHO™ |
| Neulasta®Also: Pegylated Granulocyte Colony-Stimulating Factor (PEG-GCSF)Subjects randomized to the Neulasta® treatment arm will receive the comparator drug on Day 2(day after chemotherapy treatment) of each Chemotherapy cycle. Neulasta® will be administered to the subjects at a standard dose of 6.0 mg in 0.6 ml as a subcutaneous injection. Neulasta® is also provided as a single-use pre-filled syringe. | Drug | Neulasta® |
Primary outcome
Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the first cycle of chemotherapy (FE100C).
Time frame: 21 days
25 secondary outcomes
Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the fourth cycle of chemotherapy (docetaxel).
Time frame: 21 days
Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the first chemotherapy cycle (21-day cycle FE100C)
Time frame: 21 days
Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the fourth chemotherapy cycle (21-day cycle docetaxel)
Time frame: 21 days
Incidence of severe neutropenia (ANC < 0.5 x 10^9/L) during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of febrile neutropenia defined as peak temperature ≥38.5°C and ANC < 0.5 x 10^9/L, during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of febrile neutropenia defined as peak temperature ≥38.0°C for two readings over two hours and ANC < 0.5 x 10^9/L, during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of infection and infection-related events based on use of antibiotics during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of infection and infection-related events based on the need for hospitalization during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of moderate (ANC ≥ 50 x 10^9/L) leukocytosis during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of severe (ANC ≥ 100 x 10^9/L) leukocytosis during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Blood pressure
Time frame: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Heart rate
Time frame: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Respiratory rate
Time frame: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Body Temperature
Time frame: ~ 128 ± 2 days
Incidence of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Time frame: ~ 128 ± 2 days
Duration of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Time frame: ~ 128 ± 2 days
Severity of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Time frame: ~ 128 ± 2 days
Site of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of Maximum Plasma Concentration (Cmax)
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of Time taken to reach the maximum concentration (Tmax)
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of half-life (T1/2)
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-t])
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-∞])
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-t]/AUC[0-∞])
Time frame: ~ 128 ± 2 days
Incidence of anti-drug antibodies to ANF-RHO and Neulasta
Time frame: ~ 128 ± 2 days
Results and safety
The study was stopped early (reason given: Study redesign). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANF-RHO™ and Neulasta® in people with Chemotherapy-induced Neutropenia, run by Prolong Pharmaceuticals at 8 sites in 2 countries.
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 25 inclusion and 0 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: stopped early, as of the sponsor's last update on 12 Feb 2019. 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 France, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Study redesign). Results are not available in the source record.
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?
Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the first cycle of chemotherapy (FE100C). (time frame: 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 12 Feb 2019.