Last updated: 11/04/2018 08:16:58
Open-label Study of Topotecan and Pazopanib in advanced solid tumors
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: To determined what dose of topotecan can be safely given with daily pazopanib.
Primary purpose:
Screening
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.
Timeframe: 5 weeks
Secondary outcomes:
Indications of efficacy through tumour shrinkage. Specific biomarker analysis.
Timeframe: 12 weeks
Interventions:
Drug: topotecan
Drug: pazopanib
Enrollment:
68
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Solid Tumours
Product
pazopanib, topotecan
Collaborators
Not applicable
Study date(s)
September 2008 to June 2013
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion Criteria -
- signed, written informed consent.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2013-12-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study HYT109091 can be found on the GSK Clinical Study Register.
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