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

NCT00169520 | Completed Phase 1

• 1 other identifier: KSP10003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor Cancer

Keywords

Safety; tolerability; dose limiting toxicity; solid tumors; docetaxel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

docetaxel DRUG

SB-715992 DRUG

Also known as: docetaxel

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Oxford, Oxfordshire, OX2 6PD, United Kingdom

Location

GSK Investigational Site

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Interventions

Docetaxel; ispinesib

Intervention Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2004
• Last Updated: October 16, 2008

Record last verified: 2008-10

Locations

GB (2)