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

September 18, 2013 updated by: Amgen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Graz, Austria
        • Research Site
      • Innsbruck, Austria, 6020
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Klagenfurt, Austria
        • Research Site
      • Klagenfurt, Austria, 9026
        • Research Site
      • Linz, Austria
        • Research Site
      • Linz, Austria, 4010
        • Research Site
      • Rankweil, Austria, 6830
        • Research Site
      • Rankweil, Austria
        • Research Site
      • Wien, Austria
        • Research Site
      • Wien, Austria, 1090
        • Research Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Sainte-Foy, Quebec, Canada
        • Research Site
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • Research Site
  • Germany
      • Bad Berka, Germany, 99437
        • Research Site
      • Bad Berka, Germany
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Dresden, Germany
        • Research Site
      • Halle/ Saale, Germany, 06120
        • Research Site
      • Halle/ Saale, Germany
        • Research Site
      • Hemer, Germany, 58675
        • Research Site
      • Hemer, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Budapest, Hungary, 1125
        • Research Site
      • Budapest, Hungary, 1529
        • Research Site
      • Edeleny, Hungary, 3780
        • Research Site
      • Edeleny, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Gyula, Hungary, 5703
        • Research Site
      • Matrahaza, Hungary, 3233
        • Research Site
      • Matrahaza, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
      • Pecs, Hungary, 7623
        • Research Site
      • Szekesfehervar, Hungary
        • Research Site
      • Szekesfehervar, Hungary, 8000
        • Research Site
      • Torokbalint, Hungary
        • Research Site
      • Torokbalint, Hungary, 2045
        • Research Site
      • Zalaegerszeg - Pozva, Hungary, 8900
        • Research Site
      • Zalaegerszeg - Pozva, Hungary
        • Research Site
  • Ireland
      • Cork, Ireland
        • Research Site
      • Cork, Ireland, Cork
        • Research Site
      • Dublin, Ireland, 4
        • Research Site
      • Dublin, Ireland, 8
        • Research Site
      • Dublin, Ireland
        • Research Site
  • Italy
      • Novara, Italy
        • Research Site
      • Novara, Italy, 28100
        • Research Site
      • Orbassano, Italy, 10043
        • Research Site
      • Orbassano, Italy
        • Research Site
      • Palermo, Italy
        • Research Site
      • Palermo, Italy, 90126
        • Research Site
      • Torino, Italy, 10126
        • Research Site
      • Torino, Italy
        • Research Site
  • Portugal
      • Coimbra, Portugal
        • Research Site
      • Coimbra, Portugal, 3040-316
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Lisboa, Portugal, 1649-035
        • Research Site
      • Porto, Portugal, 4200-072
        • Research Site
      • Porto, Portugal
        • Research Site
      • Vila Nova de Gaia, Portugal
        • Research Site
      • Vila Nova de Gaia, Portugal, 4430-502
        • Research Site
  • United States
    • Arizona
      • Glendale, Arizona, United States
        • Research Site
      • Glendale, Arizona, United States, 85304
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Anaheim, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Los Angeles, California, United States, 90048
        • Research Site
      • Rancho Mirage, California, United States
        • Research Site
      • Rancho Mirage, California, United States, 92270
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Research Site
      • Boynton Beach, Florida, United States
        • Research Site
      • Vero Beach, Florida, United States
        • Research Site
      • Vero Beach, Florida, United States, 32960
        • Research Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • Research Site
      • Athens, Georgia, United States
        • Research Site
      • Macon, Georgia, United States
        • Research Site
      • Macon, Georgia, United States, 31201
        • Research Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Research Site
      • Peoria, Illinois, United States
        • Research Site
    • Iowa
      • Sioux City, Iowa, United States
        • Research Site
      • Sioux City, Iowa, United States, 51101
        • Research Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Research Site
      • Paducah, Kentucky, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States, 71101
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Michigan
      • Sterling Heights, Michigan, United States, 48314
        • Research Site
      • Sterling Heights, Michigan, United States
        • Research Site
    • Montana
      • Billings, Montana, United States, 59101
        • Research Site
      • Billings, Montana, United States
        • Research Site
    • New Jersey
      • Flemington, New Jersey, United States
        • Research Site
      • Flemington, New Jersey, United States, 08822
        • Research Site
    • New York
      • Johnson City, New York, United States, 13790
        • Research Site
      • Johnson City, New York, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States
        • Research Site
      • Drexel Hill, Pennsylvania, United States, 19026
        • Research Site
      • Dunmore, Pennsylvania, United States
        • Research Site
      • Dunmore, Pennsylvania, United States, 18512
        • Research Site
      • Radnor, Pennsylvania, United States, 19087
        • Research Site
      • Radnor, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Research Site
      • Columbia, South Carolina, United States, 29203
        • Research Site
    • Tennessee
      • Germantown, Tennessee, United States
        • Research Site
      • Germantown, Tennessee, United States, 38138
        • Research Site
    • Texas
      • Austin, Texas, United States, 78705
        • Research Site
      • Austin, Texas, United States
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Gemcitabine
Intravenous infusion
Drug: Cisplatin
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Drug: Placebo
Placebo subcutaneous injection.
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.
Drug: Gemcitabine
Intravenous infusion
Drug: Cisplatin
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Biological: Romiplostim
Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
Other Names:
  • Nplate®
  • AMG 531
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.
Drug: Gemcitabine
Intravenous infusion
Drug: Cisplatin
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Biological: Romiplostim
Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
Other Names:
  • Nplate®
  • AMG 531
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.
Drug: Gemcitabine
Intravenous infusion
Drug: Cisplatin
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Biological: Romiplostim
Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
Other Names:
  • Nplate®
  • AMG 531

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 4 months
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Grade 3 or 4 Thrombocytopenia
Time Frame: 3 weeks
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.
3 weeks
Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.
Time Frame: 3 weeks
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.
3 weeks
Number of Participants With Platelet Transfusions
Time Frame: 3 weeks
Number of participants who were administered platelet transfusions during first on study treatment cycle.
3 weeks
Platelet Count on Day 22
Time Frame: Day 22
Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group
Day 22
Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle
Time Frame: 8 days
Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 15, 2006

First Submitted That Met QC Criteria

December 15, 2006

First Posted (Estimate)

December 19, 2006

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

September 18, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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