Solid TumorsPhase 2NCT01940601
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors
A Phase 2 study testing Balugrastim and Filgrastim in people with Solid Tumors, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Balugrastim and Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2015
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Histological or cytologically-confirmed solid tumor in a patient for whom the study chemotherapy regimen [Vincristine plus ifosfamide plus doxorubicin plus etoposide (VIDE), Vincristine plus doxorubicin plus cyclophosphamide alternating with ifosfamide plus etoposide (VDC/IE), Ifosfamide plus vincristine plus actinomycin D (IVA) or Ifosfamide plus vincristine plus Adriamycin (IVAd)] is considered an appropriate treatment.
- Minimum body weight of 15 kg
- Life expectancy of at least 3 months with appropriate therapy
- Female or male children and adolescents aged 2 to 17 years
- Written informed consent provided by parent(s)/legal representative(s) of the pediatric patient and patient's assent if appropriate at the time of screening.
- Fertile patients (male or female) must use highly reliable contraceptive measures.
- Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
- White blood cell (WBC) count >2.5*10^9/L, ANC ≥1.5*10^9/L, and platelet count ≥100*10^9/L (at screening and prior to chemotherapy)
Who cannot join
- Primary myeloid disorders
- Prior radiation therapy within 4 weeks of randomization into this study.
- Previous exposure to filgrastim, pegfilgrastim, lenograstim or other G-CSF less than 6 months before randomization.
- Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim or any balugrastim excipients
- Pregnancy or breastfeeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
- Major surgery, serious infection, within 3 weeks before first administration of study drug, serious trauma or compound medical procedure within the 4 weeks prior to the first study drug dose.
- Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, laboratory tests or imaging.
About this study
Official title: An Open Label, Randomized, Active Controlled, Dose Finding Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim at Doses of 300 µg/kg and 670 µg/kg in Pediatric Patients Diagnosed With Solid Tumors Receiving Chemotherapy
The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving chemotherapy.
- Conditions
- Solid Tumors
- Being tested
- Balugrastim, Filgrastim
- Keywords
- solid tumors, balugrastim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalugrastimDrug
Balugrastim 300 ug/kg and Balugrastim 670 ug/kg
FilgrastimDrug
Filgrastim 5 μg/kg
| Study group | Role | What they receive |
|---|---|---|
| Balugrastim 300 ug/kg | Experimental | Balugrastim 300 μg/kg subcutaneously (SC) administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles Receives: Drug: Balugrastim |
| Balugrastim 670 μg/kg | Experimental | Balugrastim 670 μg/kg (maximum 40 mg) SC administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles Receives: Drug: Balugrastim |
| Filgrastim 5 μg/kg | Active comparator | Filgrastim will be administered at a dose of 5 μg/kg SC once a day for at least 5 consecutive days or until absolute neutrophil count (ANC) has returned to ≥2*10^9/L for each chemotherapy cycle up to 4 cycles. The maximum period of filgrastim administration is 14 days in each cycle. Receives: Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of absolute neutrophil count (ANC)
Measured: Day 1 to 14
Secondary outcomes (7)
ANC nadir
ANC nadir (measured in 10^9/L), which is the lowest ANC recorded
Measured: Baseline to Week 16
Time to ANC nadir
Time to ANC nadir, which is the time from the beginning of chemotherapy up to the occurrence of the ANC nadir
Measured: Baseline to Week 16
Time to ANC recovery
Time to ANC recovery (ANC >1.5*10^9/L) from nadir within each treatment cycle
Measured: Baseline to Week 16
Duration of severe neutropenia (DSN)
Number of days subject experiences severe neutropenia (ANC <0.5*10^9/L)
Measured: Baseline to Week 16
Incidence of severe neutropenia
Proportion of subjects who experience severe neutropenia (ANC <0.5*10^9/L)
Measured: Baseline to Week 16
Frequency of febrile neutropenia
Frequency of febrile neutropenia (defined as body temperature >38.5°C for more than one hour [axillary measurement] and ANC <0.5*10^9/L) by cycle and across all cycles.
Measured: Baseline to Week 16
Summary of Participants with Adverse Events
Measured: From signing of informed consent to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startSep 2014
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940601
- Sponsor's protocol ID
- NEUGR-005
- Status last verified
- Jan 2015
- First submitted
- 9 Sep 2013
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Active Controlled, Dose Finding Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim at Doses of 300 µg/kg and 670 µg/kg in Pediatric Patients Diagnosed With Solid Tumors Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01940601
- Acronym / sponsor ID
- NEUGR-005
- Conditions
- Solid Tumors
- Keywords
- solid tumors, balugrastim
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Sep 2013 (estimated)
- 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 primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Balugrastim 300 ug/kg | Experimental | Drug: BalugrastimBalugrastim 300 μg/kg subcutaneously (SC) administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles |
| Balugrastim 670 μg/kg | Experimental | Drug: BalugrastimBalugrastim 670 μg/kg (maximum 40 mg) SC administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles |
| Filgrastim 5 μg/kg | Active comparator | Drug: FilgrastimFilgrastim will be administered at a dose of 5 μg/kg SC once a day for at least 5 consecutive days or until absolute neutrophil count (ANC) has returned to ≥2*10^9/L for each chemotherapy cycle up to 4 cycles. The maximum period of filgrastim administration is 14 days in each cycle. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Histological or cytologically-confirmed solid tumor in a patient for whom the study chemotherapy regimen [Vincristine plus ifosfamide plus doxorubicin plus etoposide (VIDE), Vincristine plus doxorubicin plus cyclophosphamide alternating with ifosfamide plus etoposide (VDC/IE), Ifosfamide plus vincristine plus actinomycin D (IVA) or Ifosfamide plus vincristine plus Adriamycin (IVAd)] is considered an appropriate treatment.
- Minimum body weight of 15 kg
- Life expectancy of at least 3 months with appropriate therapy
- Female or male children and adolescents aged 2 to 17 years
- Written informed consent provided by parent(s)/legal representative(s) of the pediatric patient and patient's assent if appropriate at the time of screening.
Key exclusion criteria (7 listed)
- Primary myeloid disorders
- Prior radiation therapy within 4 weeks of randomization into this study.
- Previous exposure to filgrastim, pegfilgrastim, lenograstim or other G-CSF less than 6 months before randomization.
- Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim or any balugrastim excipients
- Pregnancy or breastfeeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
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 |
|---|---|---|
| BalugrastimBalugrastim 300 ug/kg and Balugrastim 670 ug/kg | Drug | Balugrastim 300 ug/kg, Balugrastim 670 μg/kg |
| FilgrastimFilgrastim 5 μg/kg | Drug | Filgrastim 5 μg/kg |
Primary outcome
Area under the curve (AUC) of absolute neutrophil count (ANC)
Time frame: Day 1 to 14
7 secondary outcomes
ANC nadir
Time frame: Baseline to Week 16
Time to ANC nadir
Time frame: Baseline to Week 16
Time to ANC recovery
Time frame: Baseline to Week 16
Duration of severe neutropenia (DSN)
Time frame: Baseline to Week 16
Incidence of severe neutropenia
Time frame: Baseline to Week 16
Frequency of febrile neutropenia
Time frame: Baseline to Week 16
Summary of Participants with Adverse Events
Time frame: From signing of informed consent to 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Balugrastim and Filgrastim in people with Solid Tumors, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Area under the curve (AUC) of absolute neutrophil count (ANC) (time frame: Day 1 to 14). 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 14 Jan 2015.