Last updated: 11/07/2018 02:45:12
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 GSK Clinical Study Register is no longer maintained for this study.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.
Phase I study of Pazopanib Alone and In Combination with Lapatinib in Japanese Patients with Solid Tumors
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination with Lapatinib in Japanese Patients with Solid Tumors
Trial description: This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Safety and tolerability
Timeframe: before and after taking the study medications
Secondary outcomes:
Pharmacokinetics
Timeframe: over a 24 hour period
Tumor response
Timeframe: 9 weeks
Interventions:
Drug: pazopanib
Drug: Lapatinib
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
2010-30-08
Time perspective:
Not applicable
Clinical publications:
Inoue M, Ando Y, Kawada K, et al.Phase 1 study of pazopanib alone or combined with lapatinib in Japanese patients with solid tumors.Cancer Chemother Pharmacol.2014;73(4):673-83doi: 10.1007/s00280-014-2374-3
Medical condition
Carcinoma, Renal Cell
Product
lapatinib, pazopanib
Collaborators
Not applicable
Study date(s)
September 2007 to October 2015
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- Signed informed consent.
- Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- Prior treatment with pazopanib, and with lapatinib for combo part.
- Clinically significant gastrointestinal abnormalities.
Inclusion and exclusion criteria
Inclusion criteria:
- Signed informed consent.
- Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study.
- ECOG performance status of 0 or 1.
- Adequate bone marrow reserve and hepato-renal function.
- Able to swallow and retain oral medication.
- For combo part, left ventricular ejection fraction within normal range or above 50%.
Exclusion criteria:
- Prior treatment with pazopanib, and with lapatinib for combo part.
- Clinically significant gastrointestinal abnormalities.
- Sevier diseases or conditions other than cancer.
- Poorly controlled hypertension.
- Use of warfarin for therapeutic anticoagulation.
- Use of other anti-angiogenesis agents, and other ErbB inhibitors for combo part.
- Unresolved and/or unstable toxicities
- Pregnant or lactating females
Trial location(s)
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
2010-30-08
Actual study completion date
2015-14-10
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 109693 can be found on the GSK Clinical Study Register.
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