Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00413283
• Date of registration: 15/12/2006
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)
• Scientific title: Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 For Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum.
• Date of first enrolment: December 2006
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00413283
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Austria, Canada, Germany, Hungary, Ireland, Italy, Portugal, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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 < 100 x 10^9/L on Day 22 of the qualifying
cycle (for eligibility inclusion: ability to receive the same dose of chemotherapy on
study), this criteria ensures that the patient must be dose delayed for platelet
recovery

- Ability to receive the same dose and schedule of chemotherapy during the first
on-study treatment cycle as was given in the qualifying cycle (except Day 8
gemcitabine)

- Absolute neutrophil count (ANC) = 1,000/µL, hemoglobin = 9.5 g/dL, and platelet count
= 100 x 10 ^9/L on Day 1 of the first on study chemotherapy treatment cycle

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of
screening

- Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) < 3.0 x upper limit of normal (ULN) (except for patients with a confirmed
diagnosis of Gilbert's Syndrome)

- Adequate renal function; serum creatinine < 1.5 x ULN

Exclusion Criteria:

- Receipt of > 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cancer

Chemotherapy-Induced Thrombocytopenia

Lung Cancer

Solid Tumors

Thrombocytopenia

Lung Neoplasms

Oncology

Non-Small Cell Lung Cancer

Intervention(s)

Drug: Cisplatin

Drug: Placebo

Drug: Carboplatin

Drug: Gemcitabine

Biological: Romiplostim

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: 4 months]

Secondary Outcome(s)

Duration of Grade 3 or 4 Thrombocytopenia [Time Frame: 3 weeks]

Number of Participants With Platelet Transfusions [Time Frame: 3 weeks]

Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle. [Time Frame: 3 weeks]

Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle [Time Frame: 8 days]

Platelet Count on Day 22 [Time Frame: Day 22]

Secondary ID(s)

20050154

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/10/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00413283