Last updated: 11/04/2018 08:15:38

Topotecan Pharmacokinetic Characterization Study

GSK study ID
HYT104152
See study documents
Clinicaltrials.gov ID
NCT00361803
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase I Study to Characterize the Pharmacokinetics of 4 mg/m2 Weekly Intravenous Topotecan in Patients with Cancer
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

CL and Vss of total topotecan

Timeframe: 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 outcomes:

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

Timeframe: Up to 77 days

Interventions:
Drug: topotecan
Enrollment:
15
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical 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).
Medical condition
Cancer
Product
topotecan
Collaborators
Not applicable
Study date(s)
September 2006 to August 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Written informed consent
  • Performance status of 0, 1, or 2 on the Eastern Co-operative Oncology Group (ECOG) Scale
  • 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).
Inclusion and exclusion 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Status
Terminated/Withdrawn
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Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-09-08

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study HYT104152 can be found on the GSK Clinical Study Register.
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