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):

August 7, 2006
August 9, 2006
November 17, 2017
September 12, 2006
August 9, 2007   (Final data collection date for primary outcome measure)
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 ]
CL and Vss of total topotecan
Complete list of historical versions of study NCT00361803 on Archive Site
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 ]
  • Cmax
  • tmax
  • AUC(0-t)
  • AUC(0-8) of total topotecan.
  • Safety and tolerability will also be evaluated.
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Topotecan Pharmacokinetic Characterization Study
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.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: topotecan
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.
Intervention: Drug: topotecan
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).

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 9, 2007
August 9, 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: GSK Clinical Trials GlaxoSmithKline
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP