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Topotecan Pharmacokinetic Characterization Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00361803
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: topotecan Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Characterize the Pharmacokinetics of 4 mg/m2 Weekly Intravenous Topotecan in Patients With Cancer
Actual Study Start Date : September 12, 2006
Actual Primary Completion Date : August 9, 2007
Actual Study Completion Date : August 9, 2007

Resource links provided by the National Library of Medicine

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.
Drug: topotecan

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00361803

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United States, Arizona
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Kurtis, KK, Jewell RC, Hartney JT, Griffin, PP, et al. Phase I study to characterize pharmacokinetics (PK) of topotecan (T) at 4 mg/m2 administered weekly as a 30-minute IV infusion. J Clin Oncol 26: 2008 (May 20 suppl; abstr 13551).

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Responsible Party: GlaxoSmithKline Identifier: NCT00361803    
Other Study ID Numbers: HYT104152
First Posted: August 9, 2006    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
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Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents