A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study)

Phase 1

Conditions: Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 16.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864
MedDRA version: 16.0Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-001371-20-ES

Lead Sponsor: GlaxoSmithKline, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 22

Inclusion Criteria

Subjects eligible for enrolment in the study must meet all of the following criteria:
1. Written informed consent has been obtained from the subject (or subject?s legally acceptable representative) prior to performance of any study-specific procedure.
2. The subject is participating in a GSK sponsored investigational study of eltrombopag (parent study) within the past 28 days and is receiving clinical benefit without unacceptable toxicity as determined by the investigator.
3. Subjects with a QTc <450msec or <480msec for subjects with bundle branch.
4. Women must be either of non-child bearing potential (see Section 8.4.8.1, for
definition) or women with child-bearing potential and men with reproductive
potential must be willing to practice acceptable methods of birth control during the study (See Section 8.4.8.1 for acceptable methods of birth control).
5. Women of childbearing potential must have a negative serum pregnancy test within
14 days of the first dose of study treatment and agree to use effective contraception,
as defined in Section 8.4.8.1 during the study and for 4 weeks following the last dose
of study treatment.
6. Men with a female partner of childbearing potential must have either had a prior
vasectomy or agree to use effective contraception as described in Section 6.1 from time of first dose until 16 weeks after the last dose of study treatment.
7. In France, a subject will be eligible for inclusion in this study only if either affiliated
to, or a beneficiary of, a social security category.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study:
1. Permanent discontinuation of eltrombopag in the parent study based upon the study treatment discontinuation or study withdrawal criteria from the parent study.
Subjects who permanently discontinued treatment because they completed all study
related treatments remain eligible.
2. The subject is pregnant or a lactating female.
3. Any serious and/or unstable pre-existing medical, psychiatric disorder or other
conditions at the time of transition to this study that could interfere with subject?s
safety, obtaining informed consent or compliance with the study procedures, in the
opinion of the investigator or GSK Medical Monitor.
4. French subjects: the French subject has participated in any study using an
investigational drug during the previous 30 days, with the exception of eltrombopag,
in the parent study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.;Secondary Objective: Not applicable.;Primary end point(s): The objective of this study is to provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data;Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A