Clinical trial · Interventional
Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia
A Phase I/II Open-label Study of Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia (CIT) in Subjects With Advanced Soft Tissue and Bone Sarcomas Receiving Gemcitabine and Docetaxel Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to accrue subjects to the study.
Summary
Brief summary (as posted)
The purpose of this study is to study the effect of eltrombopag on chemotherapy induced thrombocytopenia. Thrombocytopenia is when there is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Connective and Soft Tissue | Connective and Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eltrombopag | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Tolerated Eltrombopag Dose
- timeFrame
- 1 year
- description
- Measured in milligrams (mg). The primary objective of the phase I study is to determine the recommended phase II dose. The maximum dose is the dose of which less than 2 of 6 patients experienced an unacceptable event/side effect
- measure
- Efficacy
- timeFrame
- 20 weeks
- description
- The primary outcome for the Phase II study is the proportion of subjects without grade 3 or 4 thrombocytopenia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 82 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic soft tissue or bone sarcoma * 18 years of age or older * Adequate blood counts * Adequate kidney and liver function * At least 1 but no more than 3 prior systemic therapy regimens for this cancer * Good performance status - able to carry out work of a light or sedentary nature Exclusion Criteria: * Pre-existing hear disease such as congestive heart failure, or arrhythmia known to increase the risk of thromboembolic events (blood clots) * Blood clot in the last 6 months, known clotting problem or platelet disorder * History of brain cancer
References
Publications (0)
Data not yet available