Status:
COMPLETED
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors
Lead Sponsor:
GlaxoSmithKline
Conditions:
Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determined what dose of topotecan can be safely given with daily pazopanib.
Detailed 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
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 24 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2013
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00732420
Start Date
September 24 2008
End Date
June 12 2013
Last Update
November 13 2017
Active Locations (3)
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1
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
2
GSK Investigational Site
Amsterdam, Netherlands, 1066 CX
3
GSK Investigational Site
Utrecht, Netherlands, 3584 CX