Clinical trial · Interventional
Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
An Open-label, Dose Ranging Study to Assess the Safety, Efficacy, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (Eltrombopag) Administered to Subjects Receiving Adriamycin and Ifosfamide (AI) Regimen
NCT00358540CI-TRIAL-00030310completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thrombocytopaenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eltrombopag | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group B
- 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
- interventionNames
- Drug: eltrombopag
- type
- EXPERIMENTAL
- label
- Group A
- 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.
- interventionNames
- Drug: eltrombopag
Primary outcomes (1)
- measure
- Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDHayes S, Mudd PN Jr, Ouellet D, Johnson BM, Williams D, Gibiansky E. Population PK/PD modeling of eltrombopag in subjects with advanced solid tumors with chemotherapy-induced thrombocytopenia. Cancer Chemother Pharmacol. 2013 Jun;71(6):1507-20. doi: 10.1007/s00280-013-2150-9. Epub 2013 Apr 6. PMID 23564375
- DERIVEDChawla SP, Staddon A, Hendifar A, Messam CA, Patwardhan R, Kamel YM. Results of a phase I dose escalation study of eltrombopag in patients with advanced soft tissue sarcoma receiving doxorubicin and ifosfamide. BMC Cancer. 2013 Mar 16;13:121. doi: 10.1186/1471-2407-13-121. PMID 23497336