Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00119171

Enrollment

Registered

2005-07-13

Start date

2004-11-30

Completion date

Unknown

Last updated

2008-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor Cancer

Keywords

Safety, tolerability, dose limiting toxicity, solid tumors, capecitabine

Brief summary

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.

Interventions

DRUGIspinesib

DRUGCapecitabine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
Plasma levels for SB-715992 and Capecitabine	will be checked at Day 1 for Cycle 1.

Secondary

Measure	Time frame
- Medical history	at screening
- ECOG Performance Status, Physical Exam, vitals, & labs	done at screening, Week 1 (each cycle), & follow-up (f/u)
- Continuous Adverse Event monitoring	throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026