Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia

NCT00886743 | Terminated Phase 2 Results

• 2 other identifiers: 3067K1-2213B2491001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 14

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.

Conditions

Severe Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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

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

  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

  Postdose Day 1 to end of treatment

Other Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of Oprelvekin

  Postdose Day 1 to end of treatment

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin

  Postdose Day 1 to end of treatment

Study Arms (1)

Oprelvekin as subcutaneous injection (50 mg/kg once daily)

OTHER

Open label treatment with oprelvekin

Drug: oprelvekin

Interventions

oprelvekin DRUG

injection, 50 mg/kg, once daily

Oprelvekin as subcutaneous injection (50 mg/kg once daily)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (14)

Pfizer Investigational Site

Santa Monica, California, 90403, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20060, United States

Location

Montgomery Cancer Center

Mount Sterling, Kentucky, 40353, United States

Location

Pfizer Investigational Site

Mount Sterling, Kentucky, 40353, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Pfizer Investigational Site

Canton, Ohio, 44718, United States

Location

Gabrail Cancer Center Research

Dover, Ohio, 44622, United States

Location

Pfizer Investigational Site

Dover, Ohio, 44622, United States

Location

Pfizer Investigational Site

Middletown, Ohio, 45042, United States

Location

Signal Point Clinical Research Center, LLC

Middletown, Ohio, 45042, United States

Location

Pfizer Investigational Site

Laredo, Texas, 78041, United States

Location

South Texas Research Alliance LLC.

Laredo, Texas, 78041, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Thrombocytopenia

Interventions

oprelvekin

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 19, 2017
• Results First Posted: April 19, 2017

Record last verified: 2017-03

Locations

US (14)