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
• 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

• Cancer
• Carcinoma, Non-Small-Cell Lung
• Chemotherapy-Induced Thrombocytopenia
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• Oncology
• Solid Tumors
• Thrombocytopenia
• Thrombocytosis

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

External Links

•   AmgenTrials clinical trials website