CClinicalTrials.gg
Sign In
CompletedNCT00046111Updated May 30, 2017

A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors

A Phase 1 interventional study of topotecan in Lung Cancer, Small Cell and Solid Tumor Cancer, sponsored by GlaxoSmithKline. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.

02

Conditions studied

  • Lung Cancer, Small Cell
  • Solid Tumor Cancer

Keywords

  • oral
  • Bioequivalence
  • Hycamtin
  • Topotecan
03

In context

Small Cell Lung Carcinoma

1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.

This study's enrollment of 1 is below the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent
  • Patients with confirmed advanced solid tumors.
  • No prior chemotherapy within 5 years of the diagnosis of SCLC (small cell lung cancer).
  • At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
  • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion criteria

Exclusion criteria:

  • Women who are pregnant or lactating.
  • Patients of child bearing potential refusing to practice adequate contraception.
  • Patients with uncontrolled vomiting.
  • Active infection.
  • Patients with clinical evidence of any gastrointestinal (GI) conditions which would alter GI absorption or GI motility.
  • Patients requiring treatment with cyclosporin A.
  • Severe medical problems other than the cancer, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
  • Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for cancer treatment.
  • Use of investigational drug within 30 days prior to the first dose of study medication.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Primary Group

    40 subjects on medium doses of Topotecan and tested for bioequivalence for 4 weeks.

    Drug: topotecan

Interventions

  • Drugtopotecan

    A topoisomerase I inhibitor used for ovarian and lung cancer treatment

06

What researchers measure

Primary outcomes

  1. To determine the bioequivalence of new formulation (test) of oral topotecan relative to the current Phase III formulation (reference) of oral topotecan by comparing AUC in patients with advanced solid tumors.

    Time frame: Four weeks

07

Study locations

5 sites
  • GSK Investigational Site
    New York, New York 10021, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19111, United States
  • GSK Investigational Site
    Nashville, Tennessee 37203, United States
  • GSK Investigational Site
    San Antonio, Texas 78229, United States
  • GSK Investigational Site
    Ottawa, Ontario K1H 1C4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00046111
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 23, 2002
Start date
Sep 2001
Primary completion
Apr 2004
Completion
Apr 2004
Last update
May 30, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Small Cell Lung Carcinoma→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion