Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag

Thrombocytopaenia Clinical Trial

Official title:
A Randomized, Blinded, Placebo-controlled, Two-Phase, Sequential Cohort, Dose Finding Study to Assess the Safety and Efficacy of an Oral Thrombopoietin Receptor Agonist, Eltrombopag (SB-497115-GR), Administered to Patients With Solid Tumors Receiving Gemcitabine Monotherapy or the Combination of Gemcitabine Plus Carboplatin or Cisplatin

Status Completed

Clinical Trial Summary

The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort, dose finding study to assess the safety and efficacy of eltrombopag in patients with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin. Phase I of the study will examine safety and tolerability of various doses of eltrombopag to identify a dose and schedule of eltrombopag. Phase II will confirm that the chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful benefit(s) to thrombocytopenic patients by improving platelet numbers.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01147809
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 2
Start date	June 2010
Completion date	March 2015

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT01440374` - A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia	Phase 2
Completed	`NCT01957176` - A Rollover Study to Provide Continued Treatment With Eltrombopag	Phase 4
Withdrawn	`NCT01055600` - Milk-only Lactation Study for Patients on Eltrombopag	Phase 4
Terminated	`NCT02158936` - A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)	Phase 3
Completed	`NCT00358540` - Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide	Phase 1
Completed	`NCT00102726` - SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adult Cancer Patients Receiving Chemotherapy	Phase 2
Completed	`NCT01236014` - Indirect Comparison Between Eltrombopag & Romiplostim	N/A
Completed	`NCT01235988` - Meta-analysis - Eltrombopag	N/A
Completed	`NCT01657552` - Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects	Phase 1