Topotecan Pharmacokinetic Characterization Study
November 13, 2017 updated by: GlaxoSmithKline
A Phase I Study to Characterize the Pharmacokinetics of 4 mg/m2 Weekly Intravenous Topotecan in Patients With Cancer
A multi-center, open label, single dose Phase I pharmacokinetic (PK) characterization of weekly IV (intravenous) topotecan given at 4mg/m2.
15 patients will be evaluated.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Written informed consent
- Performance status of 0, 1, or 2 on the Eastern Co-operative Oncology Group (ECOG) Scale
- Predicted life expectancy of at least 3 months
- Subjects with histologically or cytologically confirmed advanced solid tumors who have failed conventional therapy for their tumor type or have a tumor type for which no standard effective therapy exists; OR Patients for whom single-agent topotecan therapy is suitable
- At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery
- Must be free of post-treatment side effects (with the exception of alopecia)
- No concurrent chemotherapy, biologic therapy or radiotherapy is allowed
- Hemoglobin = 9.0 g/dL
- WBC = 3,500/mm3 [= 3.5 x 109/L]
- Neutrophils = 1,500/mm3 [= 1.5 x 109/L]
- Platelets = 100,000/mm3 [= 100.0 x 109/L]
- Calculated creatinine clearance=60 mL/min using the Cockcroft-Gault formula
- Serum bilirubin < 2.0 mg/dL (34 µmol/L) AST, SGPT/ALT and alkaline phosphatase < 2 times the upper limit of normal if liver metastases cannot be visualized by abdominal computed tomography (CT) or magnetic resonance imaging (MRI scan)
- If liver metastases are present, subjects with < 5 times the upper limit of normal are eligible to participate
Exclusion criteria:
- Women who are pregnant or lactating
- Women subjects of childbearing potential who refuse to abstain from sexual intercourse or practice adequate contraception. Childbearing potential is defined as women who are not surgically sterilized (i.e. have not had a hysterectomy, bilateral oophorectomy [ovariectomy], or bilateral tubal ligation) or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study).
- Men unwilling to abstain from sex or use effective contraception during the study and for 3 months following completion of topotecan treatment
- Subjects with uncontrolled emesis, regardless of etiology
- Active infection
- Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
- Treatment with another investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer)
- History of allergic reactions to compounds chemically related to topotecan.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All treated subjects
All subjects received Topotecan, administered intravenously over 30 minutes at 4 milligrams per meter^2 weekly for 3 weeks every 28 days.
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topotecan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
CL and Vss of total topotecan
Time Frame: Predose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.5, 4.5, 6.5, 8.5, 12, and 24 hours after the start of infusion on Day 1
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Predose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.5, 4.5, 6.5, 8.5, 12, and 24 hours after the start of infusion on Day 1
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Cmax tmax t½ AUC(0-t) AUC(0-8) of total topotecan. Safety and tolerability will also be evaluated.
Time Frame: Up to 77 days
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Up to 77 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2006
Primary Completion (Actual)
August 9, 2007
Study Completion (Actual)
August 9, 2007
Study Registration Dates
First Submitted
August 7, 2006
First Submitted That Met QC Criteria
August 7, 2006
First Posted (Estimate)
August 9, 2006
Study Record Updates
Last Update Posted (Actual)
November 17, 2017
Last Update Submitted That Met QC Criteria
November 13, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYT104152
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.