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

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

Sponsors

Lead Sponsor: GlaxoSmithKline

Source GlaxoSmithKline
Brief Summary

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.

Overall Status Completed
Start Date June 2004
Phase Phase 1
Study Type Interventional
Primary 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. throughout the study
Secondary 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). every 2 cycles
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: docetaxel

Intervention Type: Drug

Intervention Name: SB-715992

Other Name: docetaxel

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Location
Facility:
GSK Investigational Site | Oxford, Oxfordshire, OX2 6PD, United Kingdom
GSK Investigational Site | London, SW3 6JJ, United Kingdom
Location Countries

United Kingdom

Verification Date

October 2008

Responsible Party

Name Title: Study Director

Organization: GSK

Keywords
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov