NCT00136578

Brief Summary

The purpose of this study is to determine the dose regimen of Ispinesib in combination with carboplatin in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion and carboplatin is dosed by 30 minute 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 Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2004

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2006

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

August 25, 2005

Last Update Submit

September 22, 2017

Conditions

Solid Tumours

Keywords

solid tumorsdose limiting toxicitycarboplatintolerabilitySafety

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to Day 154

Secondary Outcomes (1)

  • Antitumor activity will be assessed every 2 cycles and will be recorded as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

    Up to 140

Study Arms (1)

Subjects receiving carboplatin and SB-715992

EXPERIMENTAL

Subjects will receive carboplatin on Day 1 as an intravenous (IV) infusion over 30 minutes followed by 1-hour IV infusion of SB-715992 once every 21 days.

Drug: SB-715992Drug: carboplatin

Interventions

SB-715992DRUG

SB-715992 will be available either as 5 milliliter (mL) vial containing 4 milligram (mg) of SB-715992 or 4 mL vial containing 5 mg of SB-715992 at a concentration of 1 mg/mL OR a 10 mL vial that contains 10 mg of SB-715992 in a 10 mL solution at a concentration of 1 mg/mL.

Subjects receiving carboplatin and SB-715992
carboplatinDRUG

Carboplatin will be available as sterile, lyophilized white powder available in single-dose vials containing 50 mg, 150 mg, and 450 mg of carboplatin for administration by IV infusion. Each vial will be reconstituted with either Sterile Water for Injection, USP, 5% Dextrose in Water (D 5 W), or 0.9% Sodium Chloride Injection, USP.

Subjects receiving carboplatin and SB-715992

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 50 mL/min (calculated by the Cockcroft Gault Formula).
  • Known contra-indications to the use of carboplatin, cisplatin, or other platinum-containing compounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Newcastle upon Tyne, Northumberland, NE4 6BE, United Kingdom

Location

Related Links

MeSH Terms

Interventions

ispinesibCarboplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

October 20, 2004

Primary Completion

October 25, 2006

Study Completion

October 25, 2006

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

US(1)GB(1)