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

Solid Tumor Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169520
• Other study ID #: KSP10003
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: October 15, 2008
• Start date: June 2004

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor Cancer

Intervention

Drug:
• docetaxel

• SB-715992

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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