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SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adult Cancer Patients Receiving Chemotherapy

NCT00102726 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2017-03-23

No results posted yet for this study

Summary

SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 versus placebo as treatment for patients with advanced solid tumors scheduled to receive chemotherapy with carboplatin and paclitaxel every 21 days. Patients will receive SB497115 on days 2-11 of each 21 day cycle for at least 2 cycles of chemotherapy and for a maximum of 8 cycles of chemotherapy.

Conditions

  • Thrombocytopaenia

Interventions

DRUG

SB497115

SB497115/Placebo will be administered for at least 2 cycles. Additional cycles are permited if: 1) chemotherapy is continued, 2) the subject appears to be benefitting from the study drug, and 3) the subject has not encountered greater than moderate toxicity with the study drug. The maximum number of cycles would be 8.

OTHER

Placebo

Placebo administered orally daily on days 2 through 11 of each 21-day cycle.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States
  • Argentina
  • Austria
  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • India
  • Italy
  • Mexico
  • Peru
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00102726 on ClinicalTrials.gov