Open-label Study of Topotecan and Pazopanib in Advanced S... | NCT00732420

Studies
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors

NCT00732420

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 13, 2017Actual

Enrollment

68Actual

Phase

Phase 1

Conditions

Solid Tumours

Interventions

topotecan
pazopanib

Countries

United States
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 24, 2008Actual

Primary Completion Date

Jun 12, 2013Actual

Completion Date

Jun 12, 2013Actual

First Submitted Date

Aug 11, 2008

First Submission Date that Met QC Criteria

Aug 11, 2008

First Posted Date

Aug 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2017

Last Update Posted Date

Nov 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: topotecan Drug: 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: topotecan Drug: pazopanib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
topotecan	Drug	Topoisomerase I inhibition.	Treatment Arm A Treatment Arm B

Measure	Description	Time Frame
First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.		5 weeks

Measure	Description	Time Frame
Indications of efficacy through tumour shrinkage. Specific biomarker analysis.		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria -

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.

Exclusion Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Philadelphia	Pennsylvania	19104	United States
GSK Investigational Site

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds