Phase I/II study of pazopanib and paclitaxel in advanced NSCLC
Research type
Research Study
Full 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.
IRAS ID
22805
Contact name
Elizabeth Ruth Plummer
Contact email
Eudract number
2009-010571-24
ISRCTN Number
Not available
Research summary
This is an open-label, multicenter, Phase I/II study of pazopanib in combination with paclitaxel in first-line treatment of subjects with Stage IIIBwet (with histologically- or cytologically-confirmed malignant pleural effusion) or Stage IV non-small cell lung cancer. The Phase I part of the study will also permit subjects with previously untreated advanced solid tumours for which there is no standard therapy or for whom paclitaxel is standard therapy. Phase I is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of pazopanib administered orally once daily in combination with paclitaxel administered as a 3-hour intravenous (IV) infusion once every 3 weeks. Dose escalation will occur in cohorts of 3 to 6 subjects to determine the maximum tolerated regime of pazopanib in combination with paclitaxel. At the maximum tolerated regimen, the cohort will expand to include an additional 6 subjects to further evaluate safety, tolerability, and PK, before recommending a Phase II dose regimen. All phase I subjects will receive pazopanib until disease progression, unacceptable toxicities or death. Phase II is designed to evaluate the efficacy, safety and tolerability of pazopanib in combination with paclitaxel in subjects with non-small cell lung cancer; a standard of care treatment (carboplatin and paclitaxel administered IV every 3 weeks) will be used to provide reference data for comparison with pazopanib and paclitaxel in Phase II. Pazopanib will be administered orally once daily until disease progression, unacceptable toxicities or death. Upon disease progression, subjects randomised to carboplatin and paclitaxel will be permitted to receive pazopanib monotherapy if their doctor considers this an appropriate treatment option after considering alternative options for second-line treatment. Subjects receiving pazopanib monotherapy will be followed for response, disease progression and survival.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
09/H0904/34
Date of REC Opinion
3 Aug 2009
REC opinion
Further Information Favourable Opinion