Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia
NCT00886743
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia | |||
Official Title ICMJE | Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy | |||
Brief 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 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Severe Thrombocytopenia | |||
Intervention ICMJE | Drug: oprelvekin
injection, 50 mg/kg, once daily | |||
Study Arms ICMJE | Oprelvekin as subcutaneous injection (50 mg/kg once daily)
Open label treatment with oprelvekin Intervention: Drug: oprelvekin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 19 | |||
Original Estimated Enrollment ICMJE | 40 | |||
Actual Study Completion Date ICMJE | December 2015 | |||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | Puerto Rico | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00886743 | |||
Other Study ID Numbers ICMJE | 3067K1-2213 B2491001 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |