Severe Thrombocytopenia Clinical Trial
Official title:
Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy
| Verified date | February 2016 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 19 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | Gabrail Cancer Center Research | Dover | Ohio |
| United States | Flavio Castaneda M.D. | Laredo | Texas |
| United States | South Texas Research Alliance LLC. | Laredo | Texas |
| United States | Signal Point Hematology / Oncology Inc | Middletown | Ohio |
| United States | Montgomery Cancer Center | Mount Sterling | Kentucky |
| United States | Sarcoma Oncology Center | Santa Monica | California |
| United States | Howard University | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time-matched change from baseline in QT interval corrected for heart rate using a population-specific correction formula (QTcN). Based on average across triplicates for a given hourly time point after subcutaneous (SC) administration of oprelvekin. | 35 months | Yes | |
| Secondary | Time-matched change from baseline in the following QT variables: Fridericia correction (QTcF), Bazett corrections (QTcB) | 35 months | Yes | |
| Secondary | Incidence of QTcN, QTcB and QTcF:>=450 msecs, >=480, >=500 msecs, time-matched change from baseline >=30 msecs, time-matched change from baseline >=60 msecs. Based on average across triplicates for a given hourly | 35 months | Yes | |
| Secondary | measurement. | 35 months | Yes | |
| Secondary | Pharmacokinetic (PK) parameter Cmax | 35 months | Yes | |
| Secondary | Pharmacokinetic (PK) parameter tmax | 35 months | Yes | |
| Secondary | Time-matched changes in vital signs and laboratory data. Based on the value or the average across measures for a given hourly time point if more than 1 measure taken. | 35 months | Yes |