Last updated: 11/04/2018 08:33:11
Ispinesib In Combination With Capecitabine In Patients With Solid Tumors
GSK study ID
KSP10004
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination with Capecitabine on an Every 21-Day Schedule in Subjects with Advanced Solid Tumors
Trial description: The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. 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 Ispinesib. 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:
Plasma levels for SB-715992 and Capecitabine
Timeframe: will be checked at Day 1 for Cycle 1.
Secondary outcomes:
- Medical history
Timeframe: at screening
- ECOG Performance Status, Physical Exam, vitals, & labs
Timeframe: done at screening, Week 1 (each cycle), & follow-up (f/u)
- Continuous Adverse Event monitoring
Timeframe: throughout the study
Interventions:
Drug: Ispinesib
Drug: Capecitabine
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)
November 2004 to April 2007
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.
- Bone marrow function:
- ANC greater than 1500/mm3.
- Platelet count greater than or equal to 100,000/mm3.
- Hemoglobin greater than 9 g/dL.
- Renal function:
- Calculated creatinine clearance greater than or equal to 50 mL.min.
- Total bilirubin greater than 1.5 mg/dL.
- AST/ALT less than 2.5 X upper limit of normal.
Exclusion criteria:
- Females who are pregnant or nursing.
- Pre-existing hemolytic anemia.
- Pre-existing peripheral neuropathy greater than or equal grade 2.
- Known deficiency in dihydropyrimidine dehydrogenase (DSD).
Trial location(s)
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
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
2007-13-04
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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