Severe ThrombocytopeniaPhase 2NCT00886743
Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia
A Phase 2 study testing oprelvekin in people with Severe Thrombocytopenia, run by Pfizer at 14 sites in United States.
Trial summary
This is an open-label study in which oprelvekin will be administered for the prevention of severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side effect of blocking your bone marrow from… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Thrombocytopenia
- What is being tested?
- oprelvekin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2009to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women must be 18 to 65 years of age, with nonmyeloid malignancies for whom oprelvekin is indicated.
- At least one documented occasion of adequate hematologic recovery from previous or current chemotherapy.
- Adequate renal and hepatic excretory function.
Who cannot join
- A marked baseline prolongation of QT/QTc interval (eg, repeated [two out of three readings] demonstration of a QTcF interval >450 msec.
- Additional risk factors for torsades de pointes including heart failure (subjects that have functional class III or IV congestive heart failure), hypokalemia, hypomagnesemia, or hypocalcemia.
- A pace maker or defibrillator.
- A history of LQTS, syncope, seizure, or the unexplained cardiac-related death of a family member at less than 30 years of age.
- Requirement of concomitant prescription or non-prescription medications or dietary supplements that have a risk of causing torsades de pointes or prolonged QT/QTc interval.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
Pfizer Investigational Site
Canton, Ohio, 44718
Gabrail Cancer Center Research
Dover, Ohio, 44622
Pfizer Investigational Site
Dover, Ohio, 44622
Pfizer Investigational Site
Laredo, Texas, 78041
South Texas Research Alliance LLC.
Laredo, Texas, 78041
Pfizer Investigational Site
Middletown, Ohio, 45042
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353
Pfizer Investigational Site
Mount Sterling, Kentucky, 40353
Pfizer Investigational Site
Santa Monica, California, 90403
Sarcoma Oncology Center
Santa Monica, California, 90403
Howard University
Washington D.C., District of Columbia, 20060
Pfizer Investigational Site
Washington D.C., District of Columbia, 20060
About this study
Official title: Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy
This is an open-label study in which oprelvekin will be administered for the prevention of severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side effect of blocking your bone marrow from making platelet cells. The purpose of this study is to learn more about the effects of the recommended dose of oprelvekin on the heart's electrical cycle.
- Conditions
- Severe Thrombocytopenia
- Being tested
- oprelvekin
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oprelvekinDrug
injection, 50 mg/kg, once daily
| Study group | Role | What they receive |
|---|---|---|
| Oprelvekin as subcutaneous injection (50 mg/kg once daily) | Other | Open label treatment with oprelvekin Receives: Drug: oprelvekin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)
Because the sponsor terminated the study prematurely, this population-specific correction of QT was not done. QT data collected during the study corrected using the Bazett's and Fridericia formulae are presented as secondary outcome measures.
Measured: Postdose Day 1 to end of treatment
Secondary outcomes (2)
Number of Participants With Time-matched Change From Baseline in Corrected QT (QTc) Interval ≥30 or 60 Msec Using Fridericia's (QTcF) and Bazett's (QTcB) Correction Formulas
Based on average across triplicates for a given hourly measurement.
Measured: Postdose Day 1 to end of treatment
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
Definition of QTc is based on observed individual values rather than the average across triplicate starting from Day 1 postdose through the end of treatment.
Measured: Postdose Day 1 to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Business reason, Pfizer's requested withdrawal of the Biologics License Application (BLA) . This study is not being discontinued for efficacy or safety reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886743
- Sponsor's protocol ID
- 3067K1-2213
- Other IDs
- B2491001
- Status last verified
- Mar 2017
- First submitted
- 22 Apr 2009
- Last updated
- 19 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT00886743
- Acronym / sponsor ID
- 3067K1-2213
- Conditions
- Severe Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reason, Pfizer's requested withdrawal of the Biologics License Application (BLA) . This study is not being discontinued for efficacy or safety reason
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 19 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study in which oprelvekin will be administered for the prevention of severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side effect of blocking your bone marrow from making platelet cells. The purpose of this study is to learn more about the effects of the recommended dose of oprelvekin on the heart's electrical cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oprelvekin as subcutaneous injection (50 mg/kg once daily) | Other | Drug: oprelvekinOpen label treatment with oprelvekin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women must be 18 to 65 years of age, with nonmyeloid malignancies for whom oprelvekin is indicated.
- At least one documented occasion of adequate hematologic recovery from previous or current chemotherapy.
- Adequate renal and hepatic excretory function.
Key exclusion criteria (5 listed)
- A marked baseline prolongation of QT/QTc interval (eg, repeated [two out of three readings] demonstration of a QTcF interval >450 msec.
- Additional risk factors for torsades de pointes including heart failure (subjects that have functional class III or IV congestive heart failure), hypokalemia, hypomagnesemia, or hypocalcemia.
- A pace maker or defibrillator.
- A history of LQTS, syncope, seizure, or the unexplained cardiac-related death of a family member at less than 30 years of age.
- Requirement of concomitant prescription or non-prescription medications or dietary supplements that have a risk of causing torsades de pointes or prolonged QT/QTc interval.
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 |
|---|---|---|
| oprelvekininjection, 50 mg/kg, once daily | Drug | Oprelvekin as subcutaneous injection (50 mg/kg once daily) |
Primary outcome
Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)
Time frame: Postdose Day 1 to end of treatment
Because the sponsor terminated the study prematurely, this population-specific correction of QT was not done. QT data collected during the study corrected using the Bazett's and Fridericia formulae are presented as secondary outcome measures.
2 secondary outcomes
Number of Participants With Time-matched Change From Baseline in Corrected QT (QTc) Interval ≥30 or 60 Msec Using Fridericia's (QTcF) and Bazett's (QTcB) Correction Formulas
Time frame: Postdose Day 1 to end of treatment
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
Time frame: Postdose Day 1 to end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oprelvekin in people with Severe Thrombocytopenia, run by Pfizer at 14 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 3 inclusion and 5 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 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?
Yes. Results are posted in the registry (first posted 19 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN) (time frame: Postdose Day 1 to end of treatment). 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 Apr 2017.