Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumours

Thank you

Trial Information

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


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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

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

Outcome Time Frame:

5 weeks

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

HYT109091

NCT ID:

NCT00732420

Start Date:

September 2008

Completion Date:

May 2013

Related Keywords:

  • Solid Tumours
  • pazopanib
  • Phase I
  • topotecan
  • Advanced Solid Tumors
  • Neoplasms

Name

Location

GSK Investigational SitePittsburgh, Pennsylvania  15213