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NCT01147809 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
130
Enrollment target

NCT01147809: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT01147809 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01147809, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
130 participants
Enrollment target

Study 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.

Primary Outcome

AEs are coded using the standard Medical Dictionary for Regulatory Activities (MedDRA) and were graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 4.0. AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new

Interventions

  • OTHER Placebo
  • DRUG Eltrombopag olamine

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2010-06
Est. Completion 2015-03
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT01147809 record still lists

NCT01147809 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01147809 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01147809 about?

NCT01147809 is a clinical study titled "Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag". 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 o...

What is the current status of trial NCT01147809?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2010-06. Estimated completion is 2015-03.

What interventions are being tested in trial NCT01147809?

The interventions under investigation include: Placebo (OTHER), Eltrombopag olamine (DRUG).

Who is sponsoring clinical trial NCT01147809?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01147809's enrollment target sits among peer trials

130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01147809, the US trial registry maintained by the National Library of Medicine. NCT01147809 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.