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

NCT00413283 | Completed Phase 2 Results

• 1 other identifier: 20050154
• Study Type: interventional
• Target: 63
• Locations: 8 countries
• Sites: 113

Brief 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.

Conditions

Lung Cancer; Chemotherapy-Induced Thrombocytopenia; Non-Small Cell Lung Cancer; Cancer; Lung Neoplasms; Oncology; Solid Tumors; Thrombocytopenia

Keywords

Advanced Non-Small Cell Lung Cancer; Chemotherapy Induced Thrombocytopenia; CIT; NSCLC; Stage IIIB NSCLC; Stage IV NSCLC; Gemcitabine; Carboplatin; Cisplatin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Duration of Grade 3 or 4 Thrombocytopenia

  3 weeks

• Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.

  3 weeks

• Number of Participants With Platelet Transfusions

  3 weeks

• Platelet Count on Day 22

  Day 22

• Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle

  8 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin

Romiplostim 250 μg

EXPERIMENTAL

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; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin

Romiplostim 500 μg

EXPERIMENTAL

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; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin

Romiplostim 750 μg

EXPERIMENTAL

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; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin

Interventions

Romiplostim BIOLOGICAL

Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.

Also known as: AMG 531, Nplate®

Romiplostim 250 μg; Romiplostim 500 μg; Romiplostim 750 μg

Placebo DRUG

Placebo subcutaneous injection.

Placebo

Gemcitabine DRUG

Intravenous infusion

Placebo; Romiplostim 250 μg; Romiplostim 500 μg; Romiplostim 750 μg

Carboplatin DRUG

Intravenous infusion

Placebo; Romiplostim 250 μg; Romiplostim 500 μg; Romiplostim 750 μg

Cisplatin DRUG

Intravenous infusion

Placebo; Romiplostim 250 μg; Romiplostim 500 μg; Romiplostim 750 μg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (113)

Research Site

Glendale, Arizona, 85304, United States

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Glendale, Arizona, United States

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Anaheim, California, 92801, United States

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Anaheim, California, United States

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Los Angeles, California, 90048, United States

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Los Angeles, California, United States

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Rancho Mirage, California, 92270, United States

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Rancho Mirage, California, United States

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Boynton Beach, Florida, 33435, United States

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Boynton Beach, Florida, United States

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Vero Beach, Florida, 32960, United States

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Vero Beach, Florida, United States

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Athens, Georgia, 30607, United States

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Athens, Georgia, United States

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Macon, Georgia, 31201, United States

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Macon, Georgia, United States

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Peoria, Illinois, 61615, United States

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Peoria, Illinois, United States

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Sioux City, Iowa, 51101, United States

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Sioux City, Iowa, United States

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Paducah, Kentucky, 42003, United States

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Paducah, Kentucky, United States

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Shreveport, Louisiana, 71101, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, United States

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Sterling Heights, Michigan, 48314, United States

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Sterling Heights, Michigan, United States

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Billings, Montana, 59101, United States

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Billings, Montana, United States

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Flemington, New Jersey, 08822, United States

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Flemington, New Jersey, United States

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Johnson City, New York, 13790, United States

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Johnson City, New York, United States

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Oklahoma City, Oklahoma, 73104, United States

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Oklahoma City, Oklahoma, United States

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Drexel Hill, Pennsylvania, 19026, United States

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Drexel Hill, Pennsylvania, United States

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Dunmore, Pennsylvania, 18512, United States

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Dunmore, Pennsylvania, United States

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Radnor, Pennsylvania, 19087, United States

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Radnor, Pennsylvania, United States

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Columbia, South Carolina, 29203, United States

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Columbia, South Carolina, United States

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Germantown, Tennessee, 38138, United States

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Germantown, Tennessee, United States

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Austin, Texas, 78705, United States

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Austin, Texas, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77074, United States

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Houston, Texas, United States

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Graz, 8036, Austria

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Graz, Austria

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Innsbruck, 6020, Austria

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Innsbruck, Austria

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Klagenfurt, 9026, Austria

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Klagenfurt, Austria

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Linz, 4010, Austria

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Linz, Austria

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Rankweil, 6830, Austria

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Rankweil, Austria

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Vienna, 1090, Austria

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Vienna, Austria

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Toronto, Ontario, M5G 2M9, Canada

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Toronto, Ontario, Canada

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Sainte-Foy, Quebec, G1V 4G5, Canada

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Sainte-Foy, Quebec, Canada

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Bad Berka, 99437, Germany

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Bad Berka, Germany

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Dresden, 01307, Germany

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Dresden, Germany

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Halle, 06120, Germany

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Halle, Germany

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Hemer, 58675, Germany

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Hemer, Germany

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Budapest, 1125, Hungary

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Budapest, 1529, Hungary

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Budapest, Hungary

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Edelény, 3780, Hungary

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Edelény, Hungary

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Gyula, 5703, Hungary

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Gyula, Hungary

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Mátraháza, 3233, Hungary

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Mátraháza, Hungary

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Pécs, 7623, Hungary

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Pécs, Hungary

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Székesfehérvár, 8000, Hungary

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Székesfehérvár, Hungary

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Törökbálint, 2045, Hungary

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Törökbálint, Hungary

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Zalaegerszeg - Pozva, 8900, Hungary

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Zalaegerszeg - Pozva, Hungary

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Cork, Cork, Ireland

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Cork, Ireland

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Dublin, 4, Ireland

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Dublin, 8, Ireland

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Dublin, Ireland

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Novara, 28100, Italy

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Novara, Italy

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Orbassano, 10043, Italy

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Orbassano, Italy

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Palermo, 90126, Italy

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Palermo, Italy

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Torino, 10126, Italy

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Torino, Italy

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Coimbra, 3040-316, Portugal

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Coimbra, Portugal

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Lisbon, 1649-035, Portugal

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Lisbon, Portugal

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Porto, 4200-072, Portugal

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Porto, Portugal

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Vila Nova de Gaia, 4430-502, Portugal

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Vila Nova de Gaia, Portugal

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms; Thrombocytopenia

Interventions

romiplostim; Gemcitabine; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 19, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: October 24, 2013
• Results First Posted: October 21, 2010

Record last verified: 2013-09

Locations

IT (8); PT (8); DE (8); CA (4); HU (17); AU (12); US (51); IE (5)