Sarcoma
Conditions
Brief summary
Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.
Interventions
DRUGPN-152,243)/PN-196,444
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy
Exclusion criteria
* Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis. | — |
| Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia. | — |
| Assess the likelihood that patients were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles. | — |
| Assess the safety of multiple IV doses of rhTPO. | — |
| Identify the effect of rhTPO on the number of platelet transfusions. | — |
| Assess the antitumor activity of AI chemotherapy. | — |
| Evaluate the impact of rhTPO prophylaxis on patient quality of life. | — |
| Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness. | — |
| Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration | — |
| Determine the occurrence and clinical implications of any anti-TPO antibodies. | — |
Countries
United States
Outcome results
None listed