At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of solid tumors at high risk for chemotherapy-induced severe thrombocytopenia from carboplatin (AUC=11), adriamycin/ifosfamide regimen, or high-dose ifosfamide
- ✓Age 18 years or older
- ✓Adequate hematologic function: ANC ≥1500/mm³, platelets ≥100×10⁹/L, hemoglobin ≥8 g/dL
- ✓Adequate renal function: serum creatinine ≤2.0 mg/dL
- ✕Hematologic malignancies
- ✕History of CNS metastasis
- ✕Significant cardiac disease (NYHA Class III or IV), dysrhythmia, or recent MI/ischemia/TIA/CVA within 6 months
- ✕History of thromboembolic events (DVT or pulmonary embolism)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Study of AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
In Brief
A Phase 2 clinical trial evaluating AMG 531, Carboplatin, and 2 other interventions for Solid Tumors and Advanced Cancer. Completed, enrolled 55 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy 2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy Secondary Objective: 1\. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy
Study Details
Timeline
Interventions
Beginning with Cycle 2, administered in one of two schedules, either on day after chemotherapy and 2 days later (study cycle) or on day -5 (pre dose) and on day after chemotherapy (post dose) or combination of pre/post days of 21-28 day treatment cycle. Combination if Optimal biological dose (OBD) not reached, additional treatment at 10 mcg/kg dose level, with AMG 531 administered on day -5 (pre dose) and on day after chemotherapy (post dose). 1, 3, or 10 mcg/kg given as injection under the skin (subcutaneous)
AUC=11; Cycle 1 chemotherapy alone then 3 weeks later, in Cycle 2, same dose of chemotherapy followed by AMG 531.
75-90 mg/m\^2 IV
10 gm/m\^2 IV; OR, High dose ifosfamide = 14 gm/m\^2.