Study of Pazopanib and Paclitaxel in Advanced Non-small Cell Lung Cancer

Lung Cancer, Non-Small Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866528
• Other study ID #: 111109
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2009
• Last updated: November 8, 2017
• Start date: July 9, 2009
• Est. completion date: October 25, 2012

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 25, 2012
• Est. primary completion date: October 25, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-Small Cell
• Lung Neoplasms

Intervention

Drug:
• pazopanib
oral pazopanib once daily (Phase I starting dose 800 mg)
• paclitaxel
paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Newcastle upon Tyne
United Kingdom	GSK Investigational Site	Sutton	Surrey
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: safety and tolerability (Serious adverse events, adverse events, dose-limiting toxicities, clinical laboratory data, vital signs, ECG, ECOG performance status)		at least one cycle of treatment (3 weeks)
Secondary	Phase I: paclitaxel and pazopanib pharmacokinetics		Cycle 1 and Cycle 2 PK sampling
Secondary	Phase I: clinical activity		at least 6 weeks

External Links

•   Results for study 111109 can be found on the GSK Clinical Study Register.