Clinical trial NCT00169520: SB-715992 In Combination With Docetaxel In Patients With Solid Tumors
Official title: A Phase I, Open-Label Study of SB-715992 in Combination With Docetaxel in Patients With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor Cancer
Keywords: Safety
tolerability
dose limiting toxicity
solid tumors
docetaxel
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: throughout the study
Secondary outcomes:
measure: PK endpoints of SB-715992 and docetaxel pending the conduct of the PK interaction portion. Antitumor activity will be assessed every 2 cycles (PD).
timeFrame: every 2 cycles
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
state: Oxfordshire
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: