Dose/ Schedule Finding Trial of AMG 531 for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00413283

Purpose

The purpose of this study is to identify an effective, well tolerated dose and schedule of AMG 531 (romiplostim) that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in subjects 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: AMG 531 (romiplostim) Drug: Placebo	Phase II

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:

Genetics Home Reference related topics: MYH9-related disorder

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride AMG 531

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Incidence of Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Participant incidence of adverse events

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 (platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group
Incidence of Participants Experiencing Grade 3 or 4 Thrombocytopenia (<50 x 10^9/L) During First Treatment Cycle [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Incidence of participants in each treatment group grade 3 or 4 thrombocytopenia (<50 x 10^9/L) during first on study treatment cycle
Participant Incidence of Platelet Transfusions [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Incidence 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 ]
Incidence of participants that required 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: Cohort 01: Placebo Placebo: 250 µg Dose Level	Drug: Placebo Subjects in the control group will be administered a placebo once per 21 day chemotherapy cycle by subcutaneous injection.
Placebo Comparator: Cohort 02: Placebo Placebo: 500 µg Dose Level	Drug: Placebo Subjects in the control group will be administered a placebo once per 21 day chemotherapy cycle by subcutaneous injection.
Placebo Comparator: Cohort 03: Placebo Placebo: 750 µg Dose Level	Drug: Placebo Subjects in the control group will be administered a placebo once per 21 day chemotherapy cycle by subcutaneous injection.
Experimental: Cohort 01: AMG 531 (romiplostim) AMG 531 (romiplostim): 250 µg Dose Level	Biological: AMG 531 (romiplostim) AMG 531 (romiplostim) is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 (romiplostim) will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
Experimental: Cohort 02: AMG 531 (romiplostim) AMG 531(romiplostim): 500 µg Dose Level	Biological: AMG 531 (romiplostim) AMG 531 (romiplostim) is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 (romiplostim) will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
Experimental: Cohort 03: AMG 531 (romiplostim) AMG 531 (romiplostim): 750 µg Dose Level	Biological: AMG 531 (romiplostim) AMG 531 (romiplostim) is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 (romiplostim) will be administered once per chemotherapy 21 day cycle by subcutaneous injection.

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 Q21 day gemcitabine/carboplatin or gemcitabine/cisplatin
Life expectancy > or = 12 weeks at the time of screening
Thrombocytopenia as evidenced by a platelet count < or = 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 subject 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)
ANC > or = 1,000/µL, Hgb > or = 9.5 g/dL, and platelet count > or = 100 x 10 ^9/L on Day 1 of the first on study chemotherapy treatment cycle
ECOG performance status of 0 to 2 at the time of screening
Adequate Liver function; AST and ALT < 3.0 x ULN (except for subjects 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. ITP, TTP, HUS) that may exacerbate thrombocytopenia
History of unstable angina, CHF, uncontrolled hypertension (diastolic > 100mmHG), uncontrolled cardiac arrhythmia, or recent (within 1 year of screening ) MI
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

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

Show 55 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
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:	November 24, 2010
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:

Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Thrombocytopenia
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Blood Platelet Disorders
Hematologic Diseases
Gemcitabine

Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2012