NCT00732420

Brief Summary

To determined what dose of topotecan can be safely given with daily pazopanib.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1

Geographic Reach
2 countries

3 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

First Submitted

Initial submission to the registry

August 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 24, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2013

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

4.7 years

First QC Date

August 11, 2008

Last Update Submit

November 8, 2017

Conditions

Solid Tumours

Keywords

pazopanibPhase ItopotecanAdvanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.

    5 weeks

Secondary Outcomes (1)

  • Indications of efficacy through tumour shrinkage. Specific biomarker analysis.

    12 weeks

Study Arms (2)

Treatment Arm A

EXPERIMENTAL

Daily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose.

Drug: topotecanDrug: pazopanib

Treatment Arm B

EXPERIMENTAL

Daily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose.

Drug: topotecanDrug: pazopanib

Interventions

topotecanDRUG

Topoisomerase I inhibition.

Treatment Arm ATreatment Arm B
pazopanibDRUG

Tyrosine kinase inhibitor

Treatment Arm ATreatment Arm B

Eligibility Criteria

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

You may qualify if:

  • signed, written informed consent.
  • at least 18 years of age.
  • ECOG performance status 0 or 1.
  • Subjects must have histologically or cytologically confirmed diagnosis of advanced cancer and a solid tumor malignancy that has relapsed or is refractory to standard therapy or for which there is no established therapy.
  • able to swallow and retain oral medications.
  • females are eligible to enter and participate in this study providing adequate established contraception is being practiced.

You may not qualify if:

  • had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
  • received an investigational drug within 30 days or 5 half-lives (whichever is longer).
  • received prior treatment with pazopanib/investigational anti-angiogenic compounds.
  • presence of uncontrolled infection.
  • pregnant or lactating.
  • poorly controlled hypertension (SBP of ? 140 mmHg, or DBP of ? 90 mmHg.
  • Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.-
  • arterial thrombi, myocardial infarction, admission for unstable angina, uncontrolled or symptomatic arrhythmia, cardiac angioplasty, or stenting within the last 6 months.
  • any unresolved bowel obstruction or diarrhea ? Grade 1.
  • received an allogeneic bone marrow transplant.
  • known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or topotecan.
  • any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study.
  • psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • clinical history, current alcohol or illicit drug use which, in the judgment of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Amsterdam, 1066 CX, Netherlands

Location

GSK Investigational Site

Utrecht, 3584 CX, Netherlands

Location

Related Links

MeSH Terms

Interventions

Topotecanpazopanib

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 12, 2008

Study Start

September 24, 2008

Primary Completion

June 12, 2013

Study Completion

June 12, 2013

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

US(1)NL(2)