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| ID | Type | Description | Link |
|---|---|---|---|
| B2491001 | Other Identifier | Alias Study Number |
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Business reason, Pfizer's requested withdrawal of the Biologics License Application (BLA) . This study is not being discontinued for efficacy or safety reason
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oprelvekin as subcutaneous injection (50 mg/kg once daily) | Other | Open label treatment with oprelvekin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oprelvekin | Drug | injection, 50 mg/kg, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postdose Day 1 to end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Oprelvekin | Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods. | Postdose Day 1 to end of treatment |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Santa Monica | California | 90403 | United States | ||
| Sarcoma Oncology Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 45 participants were screened; of these, 19 received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oprelvekin, 50 μg/kg | Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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. |
| Postdose Day 1 to end of treatment |
Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods. |
| Postdose Day 1 to end of treatment |
| Santa Monica |
| California |
| 90403 |
| United States |
| Howard University | Washington D.C. | District of Columbia | 20060 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20060 | United States |
| Montgomery Cancer Center | Mount Sterling | Kentucky | 40353 | United States |
| Pfizer Investigational Site | Mount Sterling | Kentucky | 40353 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| Pfizer Investigational Site | Canton | Ohio | 44718 | United States |
| Gabrail Cancer Center Research | Dover | Ohio | 44622 | United States |
| Pfizer Investigational Site | Dover | Ohio | 44622 | United States |
| Pfizer Investigational Site | Middletown | Ohio | 45042 | United States |
| Signal Point Clinical Research Center, LLC | Middletown | Ohio | 45042 | United States |
| Pfizer Investigational Site | Laredo | Texas | 78041 | United States |
| South Texas Research Alliance LLC. | Laredo | Texas | 78041 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All participants who had received at least 1 dose of oprelvekin.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oprelvekin, 50 μg/kg | Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| |||||||||||||||||||||||
| Weight | Mean | Standard Deviation | Kilograms |
| ||||||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | Kilograms/meters^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Postdose Day 1 to end of treatment |
|
| ||||||||||||||||||||
| Secondary | 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. | Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses. | Posted | Number | Participants | Postdose Day 1 to end of treatment |
|
| |||||||||||||||||
| Secondary | 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. | Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses. | Posted | Number | Participants | Postdose Day 1 to end of treatment |
|
| |||||||||||||||||
| Other Pre-specified | Maximum Observed Plasma Concentration (Cmax) of Oprelvekin | Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods. | All participants who received at least 1 dose of study drug and had at least 1 concentration assessment. | Posted | Number | picograms/mililiter | Postdose Day 1 to end of treatment |
|
| |||||||||||||||||
| Other Pre-specified | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin | Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods. | All participants who received at least 1 dose of study drug and had at least 1 concentration assessment. | Posted | Number | hours | Postdose Day 1 to end of treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oprelvekin, 50 μg/kg | Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection. | 1 | 19 | 14 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 18.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 18.1 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | 18.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | 18.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 18.1 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | 18.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | 18.1 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | 18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | 18.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | 18.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 18.1 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | 18.1 | Non-systematic Assessment |
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| Blood triglycerides increased | Investigations | 18.1 | Non-systematic Assessment |
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| Haematocrit decreased | Investigations | 18.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 18.1 | Non-systematic Assessment |
| |
| Heart rate decreased | Investigations | 18.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | 18.1 | Non-systematic Assessment |
| |
| QRS axis abnormal | Investigations | 18.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 18.1 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | 18.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 18.1 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | 18.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 18.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | 18.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | 18.1 | Non-systematic Assessment |
| |
| Short QT Interval with ST changes | Cardiac disorders | No coding dictionary | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C105308 | oprelvekin |
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| Unknown or Not Reported |
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