Phase 2
N=63
Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)
Lung Cancer · Chemotherapy-Induced Thrombocytopenia · Non-Small Cell Lung Cancer · Cancer · Lung Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00413283 ↗Enrolled (actual)
63
Serious AEs
29.0%
Results posted
Oct 2010
Primary outcome: Primary: Number of Participants With Adverse Events — 12; 16; 18; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Romiplostim (Biological); Placebo (Drug); Gemcitabine (Drug); Carboplatin (Drug); Cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
12; 16; 18; 14 | — |
| SECONDARY Duration of Grade 3 or 4 Thrombocytopenia |
2.1; 3.6; 2.6; 2.1 | 0.972 |
| SECONDARY Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle. |
5; 7; 7; 7 | 1.000 |
| SECONDARY Number of Participants With Platelet Transfusions |
1; 4; 1; 1 | 1.000 |
| SECONDARY Platelet Count on Day 22 |
281.2; 222.6; 412.8; 336.0 | 0.454 |
| SECONDARY Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle |
2; 4; 4; 5 | 0.662 |
Summary
The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed locally advanced or metastatic stage IIIB or stage IV NSCLC receiving 21-day cycles of gemcitabine/carboplatin or gemcitabine/cisplatin
- Life expectancy ≥ 12 weeks at the time of screening
- Thrombocytopenia as evidenced by a platelet count ≤ 50 x 10^9/L during the qualifying cycle of chemotherapy, OR platelet count 1 prior systemic chemotherapy regimen
- Sepsis, disseminated coagulation or any other condition (i.e. immune [idiopathic] thrombocytopenic purpura [ITP], thrombotic thrombocytopenic purpura [TTP], hemolytic uremic syndrome [HUS]) that may exacerbate thrombocytopenia
- History of unstable angina, congestive heart failure, uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year of screening ) myocardial infarction
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening
- History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots)
- Use of any nitrosourea or mitomycin-C within 6 weeks of screening
- Have received any thrombopoietic growth factor or related substance
- Have received granulocyte macrophage colony stimulating factor (GM-CSF) within the last 4 weeks prior to screening
- Have received any experimental therapy within 4 weeks prior to screening
- Have ever received a bone marrow or peripheral blood stem cell infusion (within 1 year of screening)
- Known hypersensitivity to any recombinant E. coli-derived product.
Data sourced from ClinicalTrials.gov (NCT00413283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.