Last updated: 11/04/2018 08:33:01

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

GSK study ID
KSP10003
Clinicaltrials.gov ID
NCT00169520
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase I, Open-Label Study of SB-715992 in Combination with Docetaxel in Patients with Advanced Solid Tumors.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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:

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

Interventions:
Drug: docetaxel
Drug: SB-715992
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Solid Tumor Cancer
Product
ispinesib
Collaborators
Not applicable
Study date(s)
June 2004 to October 2005
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • 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.
  • Females who are pregnant or nursing.
  • Pre-existing hemolytic anemia.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
London, United Kingdom, SW3 6JJ
Status
Study Complete
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Location
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX2 6PD
Status
Study Complete
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Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-21-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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