Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

The combination chemotherapy regimen of gemcitabine and docetaxel has become an increasingly used treatment choice for subjects with advanced sarcomas. The regimen has shown activity in first and second line for subjects with metastatic uterine leiomyosarcoma, relapsed/refractory pediatric sarcomas, and improved progression-free survival and overall survival in persons with metastatic sarcoma when compared to gemcitabine alone. The regimen has additionally been recognized as a treatment option for subjects with advanced sarcoma.

Chemotherapy-induced toxicity in the blood such as low platelet level is a common and often therapy-limiting side effect of treatment.

There are two phases in this study. The purpose of the Phase I study is to determine the recommended dose of eltrombopag. The purpose of the Phase II study is to determine the safety, tolerability, and efficacy (how well the drug works) of eltrombopag in subjects who are receiving gemcitabine and docetaxel chemotherapy.

Eltrombopag (Promacta) is an FDA approved drug for the treatment of chronic idiopathic thrombocytopenic purpura (ITP)- a condition of having an abnormally low platelet count. Eltrombopag is now being further investigated for other thrombocytopenic (low platelet)disorders.

Participants will take the assigned dose of eltrombopag once a day starting five days before each cycle of chemotherapy and for 5 days after chemotherapy. Eltrombopag is not taken on the day of chemotherapy. Eltrombopag is taken orally. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Neoplasms, Connective and Soft Tissue
Osteosarcoma
Sarcoma
Sarcoma, Soft Tissue
Thrombocytopenia
Thrombocytosis

Clinical Trial Details

NCT number	NCT01491594
Study type	Interventional
Source	Duke University
Contact
Status	Terminated
Phase	Phase 1
Start date	April 2012
Completion date	March 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00026780` - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Not yet recruiting	`NCT05515068` - Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Completed	`NCT02383901` - A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX	N/A
Active, not recruiting	`NCT01758666` - A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy	N/A
Completed	`NCT01674101` - Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy	N/A
Completed	`NCT01615640` - Diffusion Study on Patients With Osteosarcoma
Completed	`NCT00520936` - A Study of Pemetrexed in Children With Recurrent Cancer	Phase 2
Completed	`NCT00523419` - Chemotherapy for Patients With Osteosarcoma	Phase 2
Completed	`NCT00132158` - ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors	Phase 1
Not yet recruiting	`NCT04319874` - Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma	Phase 2
Recruiting	`NCT06029218` - Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy	N/A
Recruiting	`NCT05642455` - SPEARHEAD-3 Pediatric Study	Phase 1/Phase 2
Recruiting	`NCT06117878` - Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma	Early Phase 1
Not yet recruiting	`NCT04316091` - A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma	Phase 1
Recruiting	`NCT03932058` - Proteomics Research of Osteosarcoma
Withdrawn	`NCT01236586` - RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia	Phase 1
Completed	`NCT00743496` - A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma	Phase 1
Recruiting	`NCT04040205` - Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration	Phase 2
Recruiting	`NCT05970497` - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors	Phase 1
Active, not recruiting	`NCT03628209` - Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.