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

• Status: Completed
• Trial end date: 2013-06-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Topotecan

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.