Last updated: 11/04/2018 13:27:04
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Study To Assess Long Term Safety Of Pazopanib
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients
Trial description: This study is a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors
Timeframe: Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 months.
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
200
Primary completion date:
2013-13-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Carcinoma, Renal Cell
Product
lapatinib, pazopanib
Collaborators
Not applicable
Study date(s)
June 2006 to December 2016
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
- Able to understand and provide written informed consent
- The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer
- If you are pregnant or breast feeding
Inclusion and exclusion criteria
Inclusion criteria:
- Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
- Able to understand and provide written informed consent
- Women and men agree to use protocol specific birth control measures
Exclusion criteria:
- The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer
- If you are pregnant or breast feeding
- Your doctor does not think you would be a good candidate for the study
- Poorly controlled high blood pressure
- Subject is unwilling or unable to follow the procedures outlined in the protocol.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
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
No longer a GSK study
Actual primary completion date
2013-13-02
Actual study completion date
Not applicable
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
Additional information
Not applicable
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Access to clinical trial data by researchers
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