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

NCT00866528 | Completed Phase 1

• 1 other identifier: 111109
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Lung Cancer, Non-Small Cell

Keywords

paclitaxel; NSCLC; pazopanib; Advanced Non-Small Cell Lung Cancer; non-small cell lung cancer; Advanced Solid Tumor; GW786034; Metastatic Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Phase I: paclitaxel and pazopanib pharmacokinetics

  Cycle 1 and Cycle 2 PK sampling

• Phase I: clinical activity

  at least 6 weeks

Study Arms (1)

Phase I

EXPERIMENTAL

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

Drug: pazopanib; Drug: paclitaxel

Interventions

pazopanib DRUG

oral pazopanib once daily (Phase I starting dose 800 mg)

Also known as: Votrient

Phase I

paclitaxel DRUG

paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).

Phase I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Chicago, Illinois, 60637, United States

Location

GSK Investigational Site

Columbus, Ohio, 43210, United States

Location

GSK Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

GSK Investigational Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pazopanib; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: July 9, 2009
• Primary Completion: October 25, 2012
• Study Completion: October 25, 2012
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

US (2); GB (2)