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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02093325
• Date of registration: 17/03/2014
• Prospective Registration: No
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: A Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-induced Thrombocytopenia
• Scientific title: A Randomized, Double Blind Placebo-controlled Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-induced Thrombocytopenia in Patients With Solid Tumor
• Date of first enrolment: March 2014
• Target sample size: 83
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT02093325
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Hung-Hsueh Chou
• Affiliation: Clinical Trial Center, Chang Gung Memorial Hospital at Linkou

Key inclusion & exclusion criteria

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:

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Solid Tumor

Intervention(s)

Drug: Eltrombopag

Drug: Placebo

Primary Outcome(s)

efficacy of eltrombopag (50mg once daily) [Time Frame: up to treatment eltrombopag 7 days]

Secondary Outcome(s)

safety and feasibility of 7-day eltrombopag [Time Frame: up to treatment eltrombopag 7 days]

Secondary ID(s)

102-4363A3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis