NCT00046111

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2001

Typical duration for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 19, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.6 years

First QC Date

September 19, 2002

Last Update Submit

May 24, 2017

Conditions

Lung Cancer, Small CellSolid Tumor Cancer

Keywords

oralBioequivalenceHycamtinTopotecan

Outcome Measures

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.

    Four weeks

Study Arms (1)

Primary Group

EXPERIMENTAL

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

Drug: topotecan

Interventions

topotecanDRUG

A topoisomerase I inhibitor used for ovarian and lung cancer treatment

Primary Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

New York, New York, 10021, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Ottawa, Ontario, K1H 1C4, Canada

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2002

First Posted

September 23, 2002

Study Start

September 1, 2001

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

CA(1)US(4)