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NCT00413283 Clinical Trial

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

Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00413283
Other study ID # 20050154
Secondary ID
Status Completed
Phase Phase 2
First received December 15, 2006
Last updated September 18, 2013
Start date December 2006
Est. completion date February 2009

Study information
Verified date September 2013
Source Amgen
Contact n/a
Is FDA regulated No
Health authority Austria: Secretariat of HealthCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: Ministry of HealthPortugal: National Institute of Pharmacy and MedicinesUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date February 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Biological:
• Romiplostim
Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
Drug:
• Placebo
Placebo subcutaneous injection.
• Gemcitabine
Intravenous infusion
• Carboplatin
Intravenous infusion
• Cisplatin
Intravenous infusion

Locations
Country Name City State
Austria Research Site Graz
Austria Research Site Graz
Austria Research Site Innsbruck
Austria Research Site Innsbruck
Austria Research Site Klagenfurt
Austria Research Site Klagenfurt
Austria Research Site Linz
Austria Research Site Linz
Austria Research Site Rankweil
Austria Research Site Rankweil
Austria Research Site Wien
Austria Research Site Wien
Canada Research Site Sainte-Foy Quebec
Canada Research Site Sainte-Foy Quebec
Canada Research Site Toronto Ontario
Canada Research Site Toronto Ontario
Germany Research Site Bad Berka
Germany Research Site Bad Berka
Germany Research Site Dresden
Germany Research Site Dresden
Germany Research Site Halle/ Saale
Germany Research Site Halle/ Saale
Germany Research Site Hemer
Germany Research Site Hemer
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Edeleny
Hungary Research Site Edeleny
Hungary Research Site Gyula
Hungary Research Site Gyula
Hungary Research Site Matrahaza
Hungary Research Site Matrahaza
Hungary Research Site Pecs
Hungary Research Site Pecs
Hungary Research Site Szekesfehervar
Hungary Research Site Szekesfehervar
Hungary Research Site Torokbalint
Hungary Research Site Torokbalint
Hungary Research Site Zalaegerszeg - Pozva
Hungary Research Site Zalaegerszeg - Pozva
Ireland Research Site Cork
Ireland Research Site Cork
Ireland Research Site Dublin
Ireland Research Site Dublin
Ireland Research Site Dublin
Italy Research Site Novara
Italy Research Site Novara
Italy Research Site Orbassano
Italy Research Site Orbassano
Italy Research Site Palermo
Italy Research Site Palermo
Italy Research Site Torino
Italy Research Site Torino
Portugal Research Site Coimbra
Portugal Research Site Coimbra
Portugal Research Site Lisboa
Portugal Research Site Lisboa
Portugal Research Site Porto
Portugal Research Site Porto
Portugal Research Site Vila Nova de Gaia
Portugal Research Site Vila Nova de Gaia
United States Research Site Anaheim California
United States Research Site Anaheim California
United States Research Site Athens Georgia
United States Research Site Athens Georgia
United States Research Site Austin Texas
United States Research Site Austin Texas
United States Research Site Baltimore Maryland
United States Research Site Baltimore Maryland
United States Research Site Billings Montana
United States Research Site Billings Montana
United States Research Site Boynton Beach Florida
United States Research Site Boynton Beach Florida
United States Research Site Columbia South Carolina
United States Research Site Columbia South Carolina
United States Research Site Drexel Hill Pennsylvania
United States Research Site Drexel Hill Pennsylvania
United States Research Site Dunmore Pennsylvania
United States Research Site Dunmore Pennsylvania
United States Research Site Flemington New Jersey
United States Research Site Flemington New Jersey
United States Research Site Germantown Tennessee
United States Research Site Germantown Tennessee
United States Research Site Glendale Arizona
United States Research Site Glendale Arizona
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Johnson City New York
United States Research Site Johnson City New York
United States Research Site Los Angeles California
United States Research Site Los Angeles California
United States Research Site Macon Georgia
United States Research Site Macon Georgia
United States Research Site Oklahoma City Oklahoma
United States Research Site Oklahoma City Oklahoma
United States Research Site Paducah Kentucky
United States Research Site Paducah Kentucky
United States Research Site Peoria Illinois
United States Research Site Peoria Illinois
United States Research Site Radnor Pennsylvania
United States Research Site Radnor Pennsylvania
United States Research Site Rancho Mirage California
United States Research Site Rancho Mirage California
United States Research Site Shreveport Louisiana
United States Research Site Shreveport Louisiana
United States Research Site Sioux City Iowa
United States Research Site Sioux City Iowa
United States Research Site Sterling Heights Michigan
United States Research Site Sterling Heights Michigan
United States Research Site Vero Beach Florida
United States Research Site Vero Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events 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 Yes
Secondary Duration of Grade 3 or 4 Thrombocytopenia 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 No
Secondary Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle. 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 No
Secondary Number of Participants With Platelet Transfusions Number of participants who were administered platelet transfusions during first on study treatment cycle. 3 weeks No
Secondary Platelet Count on 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 No
Secondary Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle. 8 days No
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