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Status unknownNCT02093325Updated Oct 24, 2017

A Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-induced Thrombocytopenia

A Phase 3 interventional study of Eltrombopag and Placebo in Solid Tumor, sponsored by Chang Gung Memorial Hospital. Status unknown at 3 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-24.

Sponsored by Chang Gung Memorial Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is evaluate the efficacy and safety of eltrombopag as a rescue of isolated chemotherapy-induced thrombocytopenia in patients with solid tumor .

Read the detailed description

For the phase III study, a double-blind randomized, placebo controlled, parallel-group design will be conducted to evaluate the efficacy of eltombopag . Each subject will be randomly assigned to either Arm A (eltombopag) or Arm B (placebo) in 2:1 ratio.

The primary objective is to compare the response rates of the two treatment arms, Therefore, the two-proportion z test will be considered and sample size can be chosen to achieve an 95% power for detecting a clinically meaningful difference at level of significance=0.05. A difference of 40% in clinical response is considered of clinically meaningful difference between the two treatment arms (75% for eltombopag vs. 35% for placebo). It requires a total sample of 83 subjects (55 for eltombopag and 28 for placebo). According to the 10% loss of screening failure, 90-100 subjects (60-67 for eltombopag and 30-33 for placebo) will be recruited.

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Conditions studied

  • Solid Tumor

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Keywords

  • eltrombopag , thrombocytopenia, solid tumor
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In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's planned enrollment of 83 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects aged ≥18 years
  • Diagnosed with solid tumor
  • On active chemotherapy with combined regimen
  • A baseline platelet count of \<75,000/μL within 2 days of screening
  • Hb ≧ 9.0 g/dL
  • ANC ≧ 1,500/uL
  • GOT and GPT ≤ 3 x ULN
  • Serum bilirubin ≤ 1.5 x ULN
  • Albumin ≥ 2.5 g/dL
  • Adequate renal function for chemotherapy:

serum creatinine ≤ 1.5 × ULN (CTCAE Grade 1).

  • Be able to take oral medicine
  • ECOG performance ≤ 2
  • Has a negative urine or serum pregnancy test at screening and is willing to use contraceptive measures during medication of this trial (Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation and post-menopausal status) for patients with childbearing potential
  • Ability to participate and willingness to give written informed consent and to comply with the study restrictions

Exclusion criteria

Exclusion Criteria:

  • Single agent chemotherapy or not having chemotherapy
  • Serious cardiac, cerebrovascular, or pulmonary disease that, in the opinion of the investigator, would preclude trial medication
  • Severe GI tract obstruction that require continuous NG decompression
  • Subjects with hemoglobinopathies, e.g. sickle cell anaemia, thalassemia major
  • Any prior history of arterial or venous thrombosis
  • Any disease condition associated with active bleeding or requiring anticoagulation, heparin or warfarin
  • Pre-existing cardiac disease (congestive heart failure New York Heart Association (NYHA) Grade III/IV), (See Appendix 1), or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc >450 msec.
  • Seizure disorder that has not been well controlled
  • Pregnant or nursing women
  • Thyroid dysfunction not adequately controlled.
  • Within 2months prior to entering the study, been received radiotherapy to more than 20% bone marrow bearing sites.
  • Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of investigational product in the study. Concurrent participation in another interventional clinical trial or administration of any investigational drug during the study is also not permitted.
  • A known immediate or delayed hypersensitivity reaction or idiosyncrasy that, in the opinion of the Investigator is due to drugs chemically related to eltrombopag
  • Subjects taking anti-neoplastic and immunomodulatory medications (this includes mycophenolate mofetil, thymosine alpha, and extended courses of supraphysiologic doses of steroids)
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
83 participants (estimated)

Study arms

  • Experimental
    eltrombpag

    Eligible patients will be enrolled randomly in 2:1 ratio to Investigational Drug (Eltrombopag) arm, 50 mg/day, or placebo arm for 7 days.

    Drug: Eltrombopag

  • Placebo comparator
    Eltrombopag/placebo

    Eligible patients will be enrolled randomly in 2:1 ratio to Investigational Drug (Eltrombopag) arm, 50 mg/day, or placebo arm for 7 days

    Drug: Placebo

Interventions

  • DrugEltrombopag

    This will be a Phase III, randomized, double-blind, placebo-controlled clinical trial. Qualified subjects will be randomly assigned to receive either the test treatment or the placebo at 2:1 ratio. Once subjects are randomized, they will be treated with Arm A: Eltrombopag 50 mg/day (n=55) or Arm B: placebo (n=28) once a day for 7 days.

    Also known as: Revolade

  • DrugPlacebo

    This will be a Phase III, randomized, double-blind, placebo-controlled clinical trial. Qualified subjects will be randomly assigned to receive either the test treatment or the placebo at 2:1 ratio. Once subjects are randomized, they will be treated with Arm A: Eltrombopag 50 mg/day (n=55) or Arm B: placebo (n=28) once a day for 7 days.

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What researchers measure

Primary outcomes

  1. efficacy of eltrombopag (50mg once daily)

    Evaluate the efficacy of eltrombopag (50mg once daily) compared to the placebo by assessment of response rate

    Time frame: up to treatment eltrombopag 7 days

Secondary outcomes

  1. safety and feasibility of 7-day eltrombopag

    Number of Participants with Chemotherapy-induced thrombocytopenia to assess safety and feasibility to Change from Baseline in use eltrombopag at 7 days

    Time frame: up to treatment eltrombopag 7 days

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Study locations

3 sites
  • Department of Obstetrics & Gynecology and Department of Oncology Chang Gung Memorial Hospital
    Chiayi City, Taiwan
  • Department of Obstetrics & Gynecology Chang Gung Memorial Hospital
    Kaohsiung, Taiwan
  • Division of Gynecologic Oncology, Department of Obstetrics & Gynecology and Division of Oncology Chang Gung Memorial Hospital
    Linkou, Taiwan
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02093325
Lead sponsor
Chang Gung Memorial Hospital
Collaborators
Novartis
Responsible party
Sponsor
First posted
Mar 21, 2014
Start date
Mar 2014
Primary completion
Mar 2019 (estimated)
Completion
Aug 2019 (estimated)
Last update
Oct 24, 2017

Study contacts

Hung-Hsueh Chou
principal investigator · Clinical Trial Center, Chang Gung Memorial Hospital at Linkou

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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