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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00413283
First received: December 15, 2006
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Chemotherapy-Induced Thrombocytopenia
Non-Small Cell Lung Cancer
Cancer
Lung Neoplasms
Oncology
Solid Tumors
Thrombocytopenia
Biological: Romiplostim
Drug: Placebo
Drug: Gemcitabine
Drug: Carboplatin
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official 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.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.


Secondary Outcome Measures:
  • Duration of Grade 3 or 4 Thrombocytopenia [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The duration of grade 3 or 4 thrombocytopenia (defined as platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group.

  • Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count < 50 x 10^9/L, but ≥ 25 x 10^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count < 25 x 10^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.

  • Number of Participants With Platelet Transfusions [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Number of participants who were administered platelet transfusions during first on study treatment cycle.

  • Platelet Count on Day 22 [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group

  • Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.


Enrollment: 63
Study Start Date: December 2006
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Drug: Placebo
Placebo subcutaneous injection.
Drug: Gemcitabine
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Drug: Cisplatin
Intravenous infusion
Experimental: Romiplostim 250 μg
Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Biological: Romiplostim
Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
Other Names:
  • AMG 531
  • Nplate®
Drug: Gemcitabine
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Drug: Cisplatin
Intravenous infusion
Experimental: Romiplostim 500 μg
Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Biological: Romiplostim
Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
Other Names:
  • AMG 531
  • Nplate®
Drug: Gemcitabine
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Drug: Cisplatin
Intravenous infusion
Experimental: Romiplostim 750 μg
Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Biological: Romiplostim
Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
Other Names:
  • AMG 531
  • Nplate®
Drug: Gemcitabine
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Drug: Cisplatin
Intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413283

  Show 113 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00413283     History of Changes
Other Study ID Numbers: 20050154
Study First Received: December 15, 2006
Results First Received: September 24, 2010
Last Updated: September 18, 2013
Health Authority: Austria: Secretariat of Health
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Portugal: National Institute of Pharmacy and Medicines
United States: Food and Drug Administration

Keywords provided by Amgen:
Advanced Non-Small Cell Lung Cancer
Chemotherapy Induced Thrombocytopenia
CIT
NSCLC
Stage IIIB NSCLC
Stage IV NSCLC
Gemcitabine
Carboplatin
Cisplatin

Additional relevant MeSH terms:
Thrombocytopenia
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Blood Platelet Disorders
Bronchial Neoplasms
Carcinoma, Bronchogenic
Hematologic Diseases
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014