Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Thrombocytopaenia

Treatments: Drug: eltrombopag

Study type: Interventional

Funder types: Industry

Identifiers

NCT00358540

TRC105499

Details and patient eligibility

About

The study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subjects, 18 years or older
• Adequate liver and kidney function
• Prior history of ≥grade 2 thrombocytopenia (platelet nadir ≤ 75,000/microliters)
• Ability to ingest and retain oral medication
• Practice acceptable birth control
• Ability to understand and follow study requirements
• Life expectancy of at least 3 months

Exclusion criteria

• History of platelet disorders, dysfunction, or a bleeding disorder
• Anti-coagulant used within 2 weeks prior to study start
• Females who are lactating or expecting
• History of thromboembolic events or drug induced thrombocytopenia
• History of central nervous system, brain and/or leptomeningeal metastases
• Prior surgery within 2 weeks or radiotherapy within 4 weeks of study start
• Pre-existing cardiac disease

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 2 patient groups

Group B

Experimental group

Description:

Group B is a dose escalation phase designed to determine the optimal biological dose of eltrombopag in subjects with sarcoma who received chemotherapy treatment with Adriamycin and Ifosfamide

Treatment:

Drug: eltrombopag

Group A

Experimental group

Description:

Group A will be used for further exploration of the optimal biological dose (as initially established by completion of Group B), by using 2 different dosing schedules of eltrombopag.

Treatment:

Drug: eltrombopag