SB-715992 In Combination With Docetaxel In Patients With Solid Tumors

October 15, 2008 updated by: GlaxoSmithKline

A Phase I, Open-Label Study of SB-715992 in Combination With Docetaxel in Patients With Advanced Solid Tumors.

The purpose of this study is to determine the dose regimen of SB-715992 in combination with docetaxel in patients with solid tumors. SB-715992 and docetaxel were dosed by 1-hour intravenous infusion every 3 weeks (on the same day). A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with SB-715992. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.

Study Overview

Status

Completed

Conditions

Solid Tumor Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - London, United Kingdom, SW3 6JJ
    - GSK Investigational Site
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom, OX2 6PD
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.

Exclusion criteria:

Females who are pregnant or nursing.
Pre-existing hemolytic anemia.
Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens.
Absolute neutrophil count less than 1,500/mm3.
Platelets less than 100,000/mm3.
Hemoglobin less than 9 g/dL.
Total bilirubin greater than1.5 mg/dL.
AST/ALT greater than 2.5 X upper limit of normal.
Creatinine clearance less than or equal to 60 mL/min (calculated by the Cockcroft Gault Formula).
Known contraindications to the use of docetaxel or to other drugs formulated with polysorbate 80.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability endpoints will consist of the valuation of adverse events (AEs),vital signs and laboratory values. A dose regimen where 1 of 6 (or 17%) subjects experience a dose-limiting toxicity. Time Frame: throughout the study	throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
PK endpoints of SB-715992 and docetaxel pending the conduct of the PK interaction portion. Antitumor activity will be assessed every 2 cycles (PD). Time Frame: every 2 cycles	every 2 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria