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

NCT02093325 | Unknown Phase 3 DMC

• 1 other identifier: 102-4363A3
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 3

Brief 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 .

Conditions

Solid Tumor

Keywords

eltrombopag , thrombocytopenia, solid tumor

Outcome Measures

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

  up to treatment eltrombopag 7 days

Secondary Outcomes (1)

• safety and feasibility of 7-day eltrombopag

  up to treatment eltrombopag 7 days

Study Arms (2)

eltrombpag

EXPERIMENTAL

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

Eltrombopag/placebo

PLACEBO COMPARATOR

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

Eltrombopag DRUG

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

eltrombpag

Placebo DRUG

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.

Eltrombopag/placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Novartis: collaborator

Study Sites (3)

Department of Obstetrics & Gynecology and Department of Oncology Chang Gung Memorial Hospital

Chiayi City, Taiwan

Location

Department of Obstetrics & Gynecology Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Division of Gynecologic Oncology, Department of Obstetrics & Gynecology and Division of Oncology Chang Gung Memorial Hospital

Linkou District, Taiwan

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Hung-Hsueh Chou

  Clinical Trial Center, Chang Gung Memorial Hospital at Linkou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 21, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

TW (3)