Last updated: 11/07/2018 03:11:42
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 GSK Clinical Study Register is no longer maintained for this study.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 of pazopanib and paclitaxel in advanced non-small cell lung cancer
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, multicenter, phase I/II study of pazopanib in combination with paclitaxel in first-line treatment of subjects with stage IIIBwet/IV non-small cell lung cancer
Trial description: The Phase I part of the study will identify the doses of pazopanib and paclitaxel that can be administered safely in combination. The Phase II part of the study will not be progressed as documented in Protocol Amendment 01.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Phase I: safety and tolerability (Serious adverse events, adverse events, dose-limiting toxicities, clinical laboratory data, vital signs, ECG, ECOG performance status)
Timeframe: at least one cycle of treatment (3 weeks)
Secondary outcomes:
Phase I: paclitaxel and pazopanib pharmacokinetics
Timeframe: Cycle 1 and Cycle 2 PK sampling
Phase I: clinical activity
Timeframe: at least 6 weeks
Interventions:
Drug: pazopanib
Drug: paclitaxel
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
2012-25-10
Time perspective:
Not applicable
Clinical publications:
Kendra KL, Plummer ER, Salgia R, et al.A Multicenter Phase I Study of Pazopanib in Combination with Paclitaxel in First-Line Treatment of Patients with Advanced Solid Tumors.Molecular Cancer Therapeutics.2015;14(2):1-9
Medical condition
Lung Cancer, Non-Small Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
July 2009 to October 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Written informed consent
- At least 18 years old
- Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC (or for Phase I, other than the primary solid tumor)
- CNS metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent
- At least 18 years old
- Histologically- or cytologically-confirmed diagnosis of Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC (or for Phase I only, advanced solid tumor for which there is no standard therapy or for whom paclitaxel is standard therapy).
- No prior systemic first-line therapy for advanced disease
- Measurable disease
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks.
- Able to swallow and retain oral medication
- Adequate organ system function (hematological, renal, and hepatic)
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception
Exclusion criteria:
- Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC (or for Phase I, other than the primary solid tumor)
- CNS metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
- Clinically significant gastrointestinal abnormalities
- Prolongation of corrected QT interval (QTc) > 480 msecs
- History of any one or more cardiovascular conditions within the past 6 months prior to randomization
- Poorly controlled hypertension
- History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer
- Evidence of active bleeding or bleeding diathesis
- Recent hemoptysis
- Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
- Use of any prohibited medication
- Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
- Ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity except alopecia
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, paclitaxel, and/or carboplatin.
Trial location(s)
Location
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
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
No longer a GSK study
Actual primary completion date
2012-25-10
Actual study completion date
2012-25-10
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 111109 can be found on the GSK Clinical Study Register.
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