Ispinesib In Combination With Capecitabine In Patients With Solid Tumors - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00119171

Purpose

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.

Condition	Intervention	Phase
Solid Tumor Cancer	Drug: Ispinesib Drug: Capecitabine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Capecitabine Ispinesib

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Plasma levels for SB-715992 and Capecitabine [ Time Frame: will be checked at Day 1 for Cycle 1. ]

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119171

Locations

United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	KSP10004
Study First Received:	July 5, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00119171 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Safety
tolerability
dose limiting toxicity
solid tumors
capecitabine

Study placed in the following topic categories:

Antimetabolites
Capecitabine

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009