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Topotecan Pharmacokinetic Characterization Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00361803
First Posted: August 9, 2006
Last Update Posted: June 4, 2012
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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 Intervention Phase
Malignancy Solid Tumor Cancer Cancer Drug: topotecan Phase 1

Study Type: Interventional
Study Design: 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 Topotecan at 4 mg/m2 Administered Weekly as a 30-Minute Intravenous Infusion in Patients With Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • CL and Vss of total topotecan

Secondary Outcome Measures:
  • Cmax tmax t½ AUC(0-t) AUC(0-8) of total topotecan. Safety and tolerability will also be evaluated.

Estimated Enrollment: 15
Study Start Date: September 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00361803


Locations
United States, Arizona
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
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).

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00361803     History of Changes
Other Study ID Numbers: HYT104152
First Submitted: August 7, 2006
First Posted: August 9, 2006
Last Update Posted: June 4, 2012
Last Verified: March 2011

Keywords provided by GlaxoSmithKline:
chemotherapy
recurrent
refractory
research
cancer
pharmacokinetics

Additional relevant MeSH terms:
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents


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