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

Solid Tumours Clinical Trial

Official title:

A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in Combination With Pazopanib in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732420
• Other study ID #: HYT109091
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2008
• Last updated: November 8, 2017
• Start date: September 24, 2008
• Est. completion date: June 12, 2013

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in combination with Pazopanib in Subjects with Advanced Solid Tumors

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 12, 2013
• Est. primary completion date: June 12, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumours

Intervention

Drug:
• topotecan
Topoisomerase I inhibition.
• pazopanib
Tyrosine kinase inhibitor

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Utrecht
United States	GSK Investigational Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.		5 weeks
Secondary	Indications of efficacy through tumour shrinkage. Specific biomarker analysis.		12 weeks

External Links

•   Results for study HYT109091 can be found on the GSK Clinical Study Register.